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CompletedNCT00950625Updated Jan 25, 2011

Intraperitoneal Analgesia After Laparoscopic Cholecystectomy

An interventional study of lignocaine and bupevacaine in Laparoscopic Cholecystectomy, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2011-01-25.

Sponsored by Aga Khan University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
14 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Laparoscopic Cholecystectomy

Keywords

  • intraperitoneal analgesia
  • laparoscopic cholecystectomy
  • lignocaine
  • bupevacaine
03

In context

Lead sponsor

Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    intraperitoneal lignocaine

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

    Drug: lignocaine · Drug: bupevacaine

  • Active comparator
    intraperitoneal bupevacaine

    intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine after laparoscopic cholecystectomy

    Drug: lignocaine · Drug: bupevacaine

Interventions

  • Druglignocaine

    200 mg of intraperitoneal lignocaine will be given once during surgery

  • Drugbupevacaine

    100 mg of bupevacaine will be given once during laparoscopic cholecystectomy

06

What researchers measure

Primary outcomes

  1. Pain Control after Laparoscopic Cholecystectomy

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Requirement of Analgesia after laparoscopic cholecystectomy

    Time frame: 24 hours after surgery

07

Study locations

1 site
  • Aga Khan University
    Karachi, Sindh 74800, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00950625
Lead sponsor
Aga Khan University
First posted
Aug 3, 2009
Start date
Aug 2009
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Jan 25, 2011

Study contacts

Muhammad R Khan, FRCS
principal investigator · Aga Khan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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