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Intraperitoneal Analgesia After Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00950625
First received: July 31, 2009
Last updated: January 24, 2011
Last verified: July 2009
  Purpose

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 Intervention
Laparoscopic Cholecystectomy
Drug: lignocaine
Drug: bupevacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Analgesic Efficacy of Intra-peritoneal Lignocaine With Bupivacaine After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Pain Control after Laparoscopic Cholecystectomy [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Requirement of Analgesia after laparoscopic cholecystectomy [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950625

Locations
Pakistan
Aga Khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: Muhammad R Khan, FRCS Aga Khan University
  More Information

No publications provided

Responsible Party: Muhammad Rizwan Khan, Aga Khan University
ClinicalTrials.gov Identifier: NCT00950625     History of Changes
Other Study ID Numbers: 091026SUR
Study First Received: July 31, 2009
Last Updated: January 24, 2011
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
intraperitoneal analgesia
laparoscopic cholecystectomy
lignocaine
bupevacaine

Additional relevant MeSH terms:
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 20, 2014