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Background and Purpose

Question:

Discuss About The Perioperative Esmolol Early Postoperative?

The article by Ahn et al. (2015) had a clear focused issue, as it aimed to evaluate the effectiveness of intravenous lidocaine (intervention) in reducing postoperative pain (outcome) for laparascopic colectomy patient (population). The study was carried out by means of a randomized, double blind, placebo controlled study design. This indicates that participants were randomized to treatment group and the allocation sequence was concealed from investigators and patients. Few patients did not completed the trial, however data for all participant group was analyzed in the trial.


Blinding is mostly done in randomized controlled trials (RCTs) to minimize likelihood of differential treatment of outcome Karanicolas, Farrokhyar and Bhandari (2010) and Ahn et al. (2015) blinded investigator, anesthesiologist and patient to treatment. The similarity of the group was maintained by means of age range (20-65 years) and gender, however social class was not evaluated. The validity of the research is also understood from the fact that apart from experimental intervention, other protocols like administration of anesthesia and surgical technique was kept same for the participants. The primary outcome that was measured include pain level and the secondary outcome measured included incidence of vomiting, frequency of PCA device, amount of Fentanyl use and satisfaction score. On the basis of this outcome variable, the study result showed no difference in pain at discharge between the two groups, however the amount of Fentanyl use was lower in patients receiving intravenous lidocaine. Other outcomes like nausea, satisfaction score and vomiting was also less frequent in the intervention group. Hence, the study outcome proved that pain is reduced significantly in patient receiving intravenous lidocaine intraoperatively. The preciseness of the treatment effect is understood from the fact that P value for Fentanyl in control and intervention group.

The patient taken in the study were similar to the target population group, however it cannot be applied locally because it had major methodological limitation. Pain score was not measured preoperatively which was necessary to understand the effectiveness on lidocaine in pain management.  Hence, this aspect can affect decision making regarding use of lidocaine for target patient group. Despite this limitation, the study result is useful as use of lidocaine can be considered for improving recovery in patient undergoing laparascopic colectomy as its therapeutic effect is also proved by Li et al. (2018).

The review of the study by Tikuišis et al. (2014) revealed that it focused on examining the impact of IV lidocaine (intervention) on the quality of post operative pain (outcome) in patients with hand assisted laparascopic colon surgery (HALS) (population). The data for research was obtained by randomizing patients to lidocaine infusion or a normal 0.9% saline infusion. As per the requirement of a randomized controlled trial, allocation was concealed from patients and those involved in gathering data for the study. The factors related to dropout of participants were also considered as sample size was increased for this reason and there were four participants group who were excluded and not analyzed till the end. Apart from this, the researcher also eliminated treatment bias by measuring age, weight, BMI and duration of surgery in both group of patient.

Methodology


The quality of the research evidenced is also understood by the researcher’s compliance with RCT protocol. Apart from the experimental intervention, Tikuišis et al. (2014) maintained equal treatment of group by providing the same team of surgeons for performing HALS for all patient. Post-operative pain was the primary outcome analyzed for both group and length of hospital stay (LOS) and bowel function was secondary outcome measured for the study. They review of the results of the study clearly showed that intensity of pain was significantly lower in lidocaine group compared to placebo group. In addition, the mean time for first bowel movement and hospital stay was lesser in intervention group compared to control group. The preciseness of the effect is also understood from the fact that confidence interval was significantly lower for lidocaine group. The strength of this evidence is that it has targeted the right clinical outcomes to evaluate the effectiveness in target patient and this can be applied locally too. The study has useful implicating in promoting restoration of bowel function and length of hospital stay as this would save cost and lead to reduction in the cost associated with surgery too (Tam et al. 2016).

Lee et al. (2017) focused on addressing the issue of peri-operative pain control by investigating about the effectiveness of intravenous lignocaine (intervention) in reducing post-operative pain and length of hospital stay (outcome) in laparoscopic surgery patient (population). It did not used randomization method for analysis of intervention and data was collected by reviewing cases of patient who underwent elective laparoscopic resection of colorectal cancer and received lignocaine after 24 hours of operation between 2012 and 2015. Hence, the study did not used randomization method for recruitment of participant and it was a case series review. All patients who were selected for case review were analyzed and there was no need for blinding as the effect of intervention was not compared with any control. Demographic data relate to age, sex and types of surgery was analyzed, however there was no need for considering the similarity of groups as it was a case review based study.

By the analysis of data on all patients who received ligocaine infusion 24 hours post elective laparascopic resection of colorectal cancer, vital information related to pain scores, return of bowel function, time to tolerate diet, full mobilization and LOS was obtained. All these are clinically useful outcomes which can give idea regarding improvement in post-operative rehabilitation of patient. Majority of patient has good post-operative outcome and no serious side effect was reported. Although cases of mobilization issues and problem in tolerating diet were found, however these were very few. By this result, the study proved that the lignocain infusion is a feasible option for promoting pan relief in patients undergoing colorectal resection (Lee et al. 2017). However, the results are not valid for application in local population because no significant reduction in LOS was found. This means that social context of patients might be affecting this outcome and this element was not considered. Hence, this finding can be used to guide future research and prove complete efficacy of lidocaine before application in local context. Analysis of social factors in patient life is important to improve their quality of life post colorectal surgery (Bartels et al. 2010).

Primary and Secondary Outcome Measures

Wuethrich et al (2012) focused on evaluating the effect of systemic lidocaine on range of post-operative outcome in patients after laparascopic renal surgery. The last three articles analyzed only outcome measure of pain, however this study evaluated length of hospital stay, readiness for discharge, bowel function and inflammatory stress response in patient too. It also fulfilled blinding criteria in the trial by blinding participants, surgeon, nursing staff and the anesthesiologist to the group assignment. Only one patient was excluded and others were analyzed as per their allocation into the group. Other outcomes such as age, sex and social class of participants were not assessed as this may not have significant impact on the effectiveness of intervention.  Equal treatment of group was done by following the same protocol for anesthesia and keeping two staff urologist for all operations. This addressed difference in surgical procedure and time of operations too.


Wuethrich et al (2012) evaluated the benefits of lidocaine by primary outcome measure of LOS and secondary outcome measure of opioid requirement, pain intensity, side-effects, gastrointestinal function and inflammatory and stress response. No difference in LOS for lidocaine group and placebo group was found and any significant different in secondary outcomes variables were also not observed. Hence, it can be said that the study gave weak evidence for effect of systemic lidocaine on peri-operative outcome of patient with laparascopic surgery. The only favorable outcome was that difference in opioid requirement was reduced for lidocaine group. Therefore, the study cannot be applied locally as it is inconsistent with other research articles. Such unclear results might have been obtained because of too much emphasis on length of hospital stay than other clinical outcomes. Low pain score in patient might also have minimized chances of analyzing the true effect of morphine consumption. Despite this evidence, this study has given implications to researchers to create a condition, that favors analyzing the true effect of systemic lidocaine for specific surgeries. This could pave way for facilitating fast post-rehabilitation for patient as lidocaine is a minimally invasive form of analgesia (Tauzin-Fin et al. 2014).            

Unlike other research articles which compared the effect of lidocaine with saline infusion, Saadawy et al. (2010) aimed to compare the effect of lidocain and magnesium on pain, analgesic level, bowel function and quality of sleep in patients undergoing laparascopic cholecysctectomy. The intervention and comparator is clear from this study aim. Patients were randomized into three groups and all parties involved in research were blinded to study drugs and assignment of patient to different group. All patients were properly accounted for at its conclusion.

In surgical trials, ensuring a balanced group is essential so that any difference in outcome is seen only because of the effect of intervention instead of other factors (Farrokhyar et al. 2010). Saadawy et al. (2010) maintained similarity of group apart from treatment condition by providing training on use of visual analog scale to all patient and giving the same anesthesia to all. The treatment effect of lidocaine and magnesium was evaluated by means of pain score, morphine consumption, quality of sleep, side effect and time of first flatus. The level of morphine consumption was found to be significantly lower in magnesium and lidocaine group compared to saline group. Other outcomes were also similar as above, however in case of time to first flatus, the outcome was better in patients who received lidocained compared to those who received magnesium. In contrast, the favorable outcome for magnesium group was lower rate of insomnia in patient. The preciseness of the outcome is also understood from p value. Hence, the result clearly showed that both lidocaine and magnesium has analgesic sparing effect. In addition, specific therapeutic benefits of lidodacaine and magnesium were individually found. This result can be applied in local context easily based on types of pain complaints receive. This research is significant as it confirms the use of lidocaine for return of bowel function and improvement in post-operative pain. This study also gives idea for future research by investigating the possibility of using both lidocaine and magnesium for post-operative pain relief.

Results and Conclusion

Another research method focused on comparing the intraoperative effect of esmolol and lidocaine infusions on postoperative analgesia requirement in laparascopic cholecystectomy patient. The means that study had a clear issue of addressing opioid requirement after surgery in patients. The data was collected by means of randomization technique and there was no lost to follow up cases. All participants were analyzed till the end as per their allocation sequence (Özmen and Gümüfifi 2014). There is no consideration for similarity of the group at the start of the trial as this may have little impact on the outcome of the trial. However, the researcher tried to eliminate treatment biases by ensuring that apart from intervention, other conditions were kept same for all participants.  For example, all patients were premedicated with midazolam injection and anesthesia condition was also kept same.

Apart from methodological rigor in research design, the significance of the study by Özmen and Gümüfifi (2014) is understood from its result. Based on analysis of data obtained for pain scores and adverse drug effects, it was found that pain score was lower in esmolol (E) group compared to other groups and rate of Fentanyly consumption was also lowered in E group. In addition, level of vomiting, nausea and incisional pain was at similar level for all groups. Hence, the result clearly proved the superiority of esmolol in decreasing Fentanyl consumption compared to lidocaine and saline. Based on the research purpose, the study considered all relevant clinical outcome. As other operative conditions were kept similar to that of surgeries done in real setting, the study outcome is reliable and can be used in local setting too. Hence, the research is worth the cost and effort as based on this evidence, esmolol can be routines used for promoting intestinal recovery in patients during the post operative period. As the drug is an adrenergic blocker, it increases intestinal motility in patients (Watts et al. 2010). 

The uniqueness of the study by Ram et al. (2014) was that it focused on comparing the function of intravenous and intraperitoneal lignocaine in relieving pain following laparascopic cholecystectomy. The usefulness of this study is that it emphasized on form of administration to maximize pain relied unlike other studies. The randomization criteria was maintained by allocating participants to the two treatment group and involving a person independent of research involvement to fulfill allocation concealment criteria. Data obtained from all the participants were analyzed till the end. The similarity of participants groups were maintained on the basis of age range (20 to 60 years), however social factors were not considered. Despite this, the strength of research methodology is that the study protocol revealed that the researcher focused on providing equal condition to all participants and this is evident from the use of standard anesthesia protocol for all.

Outcome variable is an important component to effectively estimate the therapeutic benefits of an intervention and Ram et al. (2014) evaluated primary outcome variable of analgesic requirement in patient. Secondary outcomes that were analyzed included pain score, stress response, vomiting and bowel activity. The study result is significant as it clearly differentiated outcome in IV group and intraperitoneal group (IP). VAS (Visual Analog Score) decreased significantly in IP group, however first analgesic requirement was longer for patients in IV group. The time taken to return to bowel activity was also lesser in IV group compared to IP group. Hence, these research outcomes clearly proved the superiority of IV lignocaine over IP lignocaine in reducing post operative lignocaine requirement. The study is reliable as it has addressed all methodological requirements for a quality RCT and all chances of bias have been addressed. Important clinical outcomes were considered too. The merit of the study based on cost and effort is that it provided solid evidence regarding the most efficacious route of administration of lignocaine for recovery of patient. Hence, surgeons can encourage use of IV lignocaine instead of IP to reduce cost and promote recovery of patient too as the study is consistent with other research work too (Tauzin-Fin et al. 2014).

Limitations and Implications

Yang et al. (2014) also had similar research focus like that of Ram et al. (2014). However, instead of randomizing patient only to intravenous and intraperitoneal lignocaine group, third group of control of IV saline was also taken. The surgeon and the anesthesiologist were blinded to the patient group and few lost to follow-up cases were also found as those patients had other morbidities like allergy to anesthetics and cardiac diseases. As it was a double blind trial, both researcher as well as participants was blinded for treatment. The researcher’s emphasis of removing selection bias is seen by excluding patients having history of abdominal surgery and socioeconomic consideration for sample recruitment was missing. Despite this, research rigor is evident by the review of study design and consideration of anesthesia protocol for all. Considering anesthesia protocol was important because in many patients, anesthesia is the reason behind post-operative pain and other complication (Bafna et al. 2014).

The study results gave valuable date related to post operative pain severity (primary outcome) and secondary outcome in relation to satisfaction score, time to bowel, diet and LOS. The treatment effect was not huge as no statistically significant difference was found in case of quantity of lidocaine for IV and IP group. The intensity of pain was lower in IP group compared to IV group. Other adverse effect was less prevalent in intervention group compared to control group. From this outcome, it can be concluded that the study clearly showed therapeutic effect of IP and IV lidocaine compared to control group in reducing analgesic consumption and post operative pain in laparascopic cholecystectomy patient. However, the study has limitations and cannot be applied locally as it did not clarified regarding the use of both for patient or regarding the mechanism of action for systemic analgesia (Yang et al. 2014). Hence, this study is useful not for application in real setting as it did not clarified regarding use of combination of both drugs and proposed efficacy of IV lidocaine only on the basis of convenience.

Lauwick et al. (2008) focused on identifying whether intraoperative infusion of lidocaine can reduce fentanyl requirement in patients with laparoscopic cholecystectomy or not. Hence, from this, the aim of the research and the main clinical issue is understood. The study was conducted by means of a prospective randomized and observed blinded design and allocation concealment requirement was fulfilled too. The blinding was done only for observer and not participants of the study. Despite this, biasness was minimized by ensuring that staffs, who were aware about allocation sequences did not interacted with nurses and other anesthesiologist.  The similarity of participants was maintained only in terms of age and history of other ailments. However, the validity of the research is high because the researchers utilized strategies to ensure that apart from interventions, other conditions were kept same for all participants.


The main research outcome that was analyzed in the RCT was amount of fentanyl administered to patient and secondary outcome included experience of nausea and time spent in PACU. Reduction in the requirement for analgesic was found for lidocaine group, however other outcomes such nausea, pain score and fatigue was found same for both intervention and control group. Hence, this result proved that intravenous lidocain infusion can reduce requirement of fentanyl post operatively. The mechanism behind such outcome was explained too. However, the study outcome cannot be applied in local setting because of selection bias. The study was done with more number of males in the control group and this makes the research data unreliable (Lauwick et al. 2008). Despite this methodological limitation, the study gives implication for future research. As clear data on impact of lidocaine in reducing vomiting and nausea was not found, future research should focus on this area. This would pave way for optimal recovery of patients post surgery.

Review of Other Studies

Kim et al. (2011) also focused on comparing the effect of intreperitoneal lidocaine with intravenous lidocaine for pain relief, however in this case the research was done in patients undergoing laparascopic appendectomy. The participants were randomized into three groups and the study investigators were blinded to the details of the research. They were some patients who were not included for analysis till the end. The possibility of biasness is also evident because participants similarity in terms of age and social factors were not considered. However, as the research is focusing mainly on the effect of intervention in selected patient group, this limitation may have negligible impact on study outcome. Equal treatment of group was done by keeping the anesthesia protocol and surgical technique same for all participants group. This enhanced the validity and quality of research trial.

The review of results showed that primary outcome variable for study was VAS score and the secondary outcome measure included shoulder tip pain, Fentanyl consumption and frequency of vomiting and nausea. For all the outcomes, favorable outcome was found for IV and IP group compared to control group, thus showing that both intraperitoneal and intravenous lidocaine are effective in reducing post operative pain laparascopic appendectomy patient. Despite this outcome, the results cannot be applied locally because lidocaine concentration between IV and IP was not evaluated (Kim et al. 2011). This areas needs to be considered to determine which delivery method is efficacious for pain relief. However, the study proposed intravenous lidocaine as a safer procedure for patient which is consistent with other studies too (e Silva et al. 2017).

Reference:

Ahn, E., Kang, H., Choi, G.J., Park, Y.H., Yang, S.Y., Kim, B.G. and Choi, S.W., 2015. Intravenous lidocaine for effective pain relief after a laparoscopic colectomy: a prospective, randomized, double-blind, placebo-controlled study. International surgery, 100(3), pp.394-401.

Bafna, U., Rajarajeshwaran, K., Khandelwal, M. and Verma, A.P., 2014. A comparison of effect of preemptive use of oral gabapentin and pregabalin for acute post-operative pain after surgery under spinal anesthesia. Journal of anaesthesiology, clinical pharmacology, 30(3), p.373.

Bartels, S.A., Vlug, M.S., Ubbink, D.T. and Bemelman, W.A., 2010. Quality of life after laparoscopic and open colorectal surgery: a systematic review. World Journal of Gastroenterology: WJG, 16(40), p.5035.

e Silva, L.O.J., Scherber, K., Cabrera, D., Motov, S., West, C.P., Murad, M.H. and Bellolio, M.F., 2017. 234 Safety and Efficacy of Intravenous Lidocaine for Pain Management in the Emergency Department: A Systematic Review and Meta-Analysis. Annals of Emergency Medicine, 70(4), p.S93.

Farrokhyar, F., Bajammal, S., Kahnamoui, K. and Bhandari, M., 2010. Ensuring balanced groups in surgical trials. Canadian Journal of Surgery, 53(6), p.418.

Karanicolas, P.J., Farrokhyar, F. and Bhandari, M., 2010. Blinding: Who, what, when, why, how?. Canadian journal of surgery, 53(5), p.345.

Kim, T.H., Kang, H., Hong, J.H., Park, J.S., Baek, C.W., Kim, J.Y., Jung, Y.H. and Kim, H.K., 2011. Intraperitoneal and intravenous lidocaine for effective pain relief after laparoscopic appendectomy: a prospective, randomized, double-blind, placebo-controlled study. Surgical endoscopy, 25(10), pp.3183-3190.

Lauwick, S., Kim, D.J., Michelagnoli, G., Mistraletti, G., Feldman, L., Fried, G. and Carli, F., 2008. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Canadian Journal of Anesthesia, 55(11), p.754.

Lee, M.W., Or, D.Y., Tsang, A.C., Ng, D.C., Chen, P.P., Cheung, M.H., Li, R.S. and Leong, H.T., 2017. Intravenous lignocaine infusion facilitates acute rehabilitation after laparoscopic colectomy in the Chinese patients. Hong Kong Med J, 23(5), pp.441-5.

Li, M.J., Wang, M.G., Xu, M.W., Ding, M.M. and Yu, M.W., 2018. Efficacy of intravenous lidocaine on pain relief in patients undergoing laparoscopic cholecystectomy: A meta-analysis from randomized controlled trials. International Journal of Surgery.

Özmen, M. and Gümüfifi, H., 2014. A COMPARISON OF THE EFFECTS OF INTRAOPERATIVE ESMOLOL AND LIDOCAINE INFUSIONS ON POSTOPERATIVE ANALGESIA.

Ram, D., Sistla, S.C., Karthikeyan, V.S., Ali, S.M., Badhe, A.S. and Mahalakshmy, T., 2014. Comparison of intravenous and intraperitoneal lignocaine for pain relief following laparoscopic cholecystectomy: a double-blind, randomized, clinical trial. Surgical endoscopy, 28(4), pp.1291-1297.

Saadawy, I.M., Kaki, A.M., Abd El Latif, A.A., ABD?ELMAKSOUD, A.M. and Tolba, O.M., 2010. Lidocaine vs. magnesium: effect on analgesia after a laparoscopic cholecystectomy. Acta Anaesthesiologica Scandinavica, 54(5), pp.549-556.

Tam, M.S., Kaoutzanis, C., Mullard, A.J., Regenbogen, S.E., Franz, M.G., Hendren, S., Krapohl, G., Vandewarker, J.F., Lampman, R.M. and Cleary, R.K., 2016. A population-based study comparing laparoscopic and robotic outcomes in colorectal surgery. Surgical endoscopy, 30(2), pp.455-463.

Tauzin-Fin, P., Bernard, O., Sesay, M., Biais, M., Richebe, P., Quinart, A., Revel, P. and Sztark, F., 2014. Benefits of intravenous lidocaine on post-operative pain and acute rehabilitation after laparoscopic nephrectomy. Journal of anaesthesiology, clinical pharmacology, 30(3), p.366.

Tauzin-Fin, P., Bernard, O., Sesay, M., Biais, M., Richebe, P., Quinart, A., Revel, P. and Sztark, F., 2014. Benefits of intravenous lidocaine on post-operative pain and acute rehabilitation after laparoscopic nephrectomy. Journal of anaesthesiology, clinical pharmacology, 30(3), p.366.

Tikuišis, R., Miliauskas, P., Samalavi?ius, N.E., Žurauskas, A., Samalavi?ius, R. and Zabulis, V., 2014. Intravenous lidocaine for post-operative pain relief after hand-assisted laparoscopic colon surgery: a randomized, placebo-controlled clinical trial. Techniques in coloproctology, 18(4), pp.373-380.

Watts, R., Thiruvenkatarajan, V., Calvert, M., Newcombe, G. and van Wijk, R.M., 2017. The effect of perioperative esmolol on early postoperative pain: a systematic review and meta-analysis. Journal of anaesthesiology, clinical pharmacology, 33(1), p.28.

Wuethrich, P.Y., Romero, J., Burkhard, F.C. and Curatolo, M., 2012. No benefit from perioperative intravenous lidocaine in laparoscopic renal surgery: a randomised, placebo-controlled study. European Journal of Anaesthesiology (EJA), 29(11), pp.537-543.

Yang, S.Y., Kang, H., Choi, G.J., Shin, H.Y., Baek, C.W., Jung, Y.H. and Choi, Y.S., 2014. Efficacy of intraperitoneal and intravenous lidocaine on pain relief after laparoscopic cholecystectomy. Journal of International Medical Research, 42(2), pp.307-319.

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