Intraperitoneal Analgesia After Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Laparoscopic Cholecystectomy
• Interventions: Drug: lignocaine; Drug: bupevacaine

• Registration Number: NCT00950625
• Lead Sponsor: Aga Khan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-07
• Study First Submitted: 2009-07-31
• Study First Submitted QC: 2009-07-31
• Study Start: 2009-08
• Study First Posted: 2009-08-03
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intraperitoneal lignocaine	bupevacaine	Intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine for pain control after laparoscopic cholecystectomy
intraperitoneal bupevacaine	bupevacaine	intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine after laparoscopic cholecystectomy
intraperitoneal lignocaine	lignocaine	Intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine for pain control after laparoscopic cholecystectomy
intraperitoneal bupevacaine	lignocaine	intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine after laparoscopic cholecystectomy

Primary Outcome Measures

Name	Time	Method
Pain Control after Laparoscopic Cholecystectomy	24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Requirement of Analgesia after laparoscopic cholecystectomy	24 hours after surgery

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sindh, Pakistan