Intraperitoneal Analgesia After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Although laparoscopic cholecystectomy is associated with less pain than contemporary open procedures; it is definitely not pain free and the magnitude of postoperative shoulder and abdominal pain in the early postoperative period is still quite significant. This postoperative pain is a major concern not only for the patients, but also healthcare workers; and it often contributes to overnight hospital stay after this minimally invasive surgical procedure. Intraperitoneal instillation of local anesthetics at the time of surgery to control pain after laparoscopic cholecystectomy has been extensively studied in numerous randomized trials and found to be extremely useful. Lignocaine and Bupivacaine are two commonly used local anesthetic agents. In view of contradictory results from previous studies, it is not yet clear which of these two agents is superior to the other for pain control in this setting. To answer this question, we have designed a prospective randomized controlled trial and the specific aim of the study is to compare the analgesic efficacy of intraperitoneal lignocaine with intraperitoneal Bupivacaine in the postoperative setting after laparoscopic cholecystectomy. If we can improve pain control after this minimally invasive procedure, it might result in decreased postoperative requirement of narcotic analgesia and its associated side-effects. It may also result in early recovery and the same day discharge of the patients with significant cost-containment for the patient and healthcare systems in future.

Official Title
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Comparison of Analgesic Efficacy of Intra-peritoneal Lignocaine With Bupivacaine After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial

Conditions
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Laparoscopic Cholecystectomy

Intervention / Treatment
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* Drug: lignocaine
* Drug: bupevacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of symptomatic gallstones requiring laparoscopic cholecystectomy Elective surgical procedure American Society of Anesthesiologists class I and II Exclusion Criteria: Patients refusing randomization Patients already on analgesics Patients with acute cholecystitis Patients requiring preoperative cholangiogram or common bile duct exploration Patients having bile or stone spillage during procedure Patients requiring conversion to open procedure Patients requiring re-exploration for any reason Patients with history of allergy to local anesthetic agents

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intraperitoneal lignocaine<br>Intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine for pain control after laparoscopic cholecystectomy | Drug: lignocaine<br>* 200 mg of intraperitoneal lignocaine will be given once during surgery<br>Drug: bupevacaine<br>* 100 mg of bupevacaine will be given once during laparoscopic cholecystectomy<br>|
| Active Comparator: intraperitoneal bupevacaine<br>intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine after laparoscopic cholecystectomy | Drug: lignocaine<br>* 200 mg of intraperitoneal lignocaine will be given once during surgery<br>Drug: bupevacaine<br>* 100 mg of bupevacaine will be given once during laparoscopic cholecystectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Control after Laparoscopic Cholecystectomy |  | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Requirement of Analgesia after laparoscopic cholecystectomy |  | 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraperitoneal analgesia, laparoscopic cholecystectomy, lignocaine, bupevacaine