Intraperitoneal Analgesia After Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950625
• Other study ID #: 091026SUR
• Status: Completed
• Phase: N/A
• First received: July 31, 2009
• Last updated: January 24, 2011
• Start date: August 2009
• Est. completion date: August 2010

Study information

• Verified date: July 2009
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Drug:
• lignocaine
200 mg of intraperitoneal lignocaine will be given once during surgery
• bupevacaine
100 mg of bupevacaine will be given once during laparoscopic cholecystectomy

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Control after Laparoscopic Cholecystectomy		24 hours after surgery	Yes
Secondary	Requirement of Analgesia after laparoscopic cholecystectomy		24 hours after surgery	No