Intraperitoneal Analgesia After Laparoscopic Cholecystectomy

• Sponsor: Aga Khan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00950625
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 16.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Cholecystectomy	Drug: lignocaine; Drug: bupevacaine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Analgesic Efficacy of Intra-peritoneal Lignocaine With Bupivacaine After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: intraperitoneal lignocaine Intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine for pain control after laparoscopic cholecystectomy	Drug: lignocaine; 200 mg of intraperitoneal lignocaine will be given once during surgery; Drug: bupevacaine; 100 mg of bupevacaine will be given once during laparoscopic cholecystectomy
Active Comparator: intraperitoneal bupevacaine intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine after laparoscopic cholecystectomy	Drug: lignocaine; 200 mg of intraperitoneal lignocaine will be given once during surgery; Drug: bupevacaine; 100 mg of bupevacaine will be given once during laparoscopic cholecystectomy

Outcome Measures

Primary Outcome Measures

1. Pain Control after Laparoscopic Cholecystectomy [24 hours after surgery]

Secondary Outcome Measures

1. Requirement of Analgesia after laparoscopic cholecystectomy [24 hours after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aga Khan University	Karachi	Sindh	Pakistan	74800

Sponsors and Collaborators

• Aga Khan University

Investigators

• Principal Investigator: Muhammad R Khan, FRCS, Aga Khan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00950625
• Other Study ID Numbers: 091026SUR
• First Posted: Aug 3, 2009
• Last Update Posted: Jan 25, 2011
• Last Verified: Jul 1, 2009

• Keywords provided by , ,: intraperitoneal analgesia; laparoscopic cholecystectomy; lignocaine; bupevacaine
• Additional relevant MeSH terms: Lidocaine

Study Results

No Results Posted as of Jan 25, 2011