NCT00950625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

January 25, 2011

Status Verified

July 1, 2009

Enrollment Period

1 year

First QC Date

July 31, 2009

Last Update Submit

January 24, 2011

Conditions

Laparoscopic Cholecystectomy

Keywords

intraperitoneal analgesialaparoscopic cholecystectomylignocainebupevacaine

Outcome Measures

Primary Outcomes (1)

  • Pain Control after Laparoscopic Cholecystectomy

    24 hours after surgery

Secondary Outcomes (1)

  • Requirement of Analgesia after laparoscopic cholecystectomy

    24 hours after surgery

Study Arms (2)

intraperitoneal lignocaine

ACTIVE COMPARATOR

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

Drug: lignocaineDrug: bupevacaine

intraperitoneal bupevacaine

ACTIVE COMPARATOR

intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine after laparoscopic cholecystectomy

Drug: lignocaineDrug: bupevacaine

Interventions

lignocaineDRUG

200 mg of intraperitoneal lignocaine will be given once during surgery

intraperitoneal bupevacaineintraperitoneal lignocaine
bupevacaineDRUG

100 mg of bupevacaine will be given once during laparoscopic cholecystectomy

intraperitoneal bupevacaineintraperitoneal lignocaine

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of symptomatic gallstones requiring laparoscopic cholecystectomy
  • Elective surgical procedure
  • American Society of Anesthesiologists class I and II

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Muhammad R Khan, FRCS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 31, 2009

First Posted

August 3, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

January 25, 2011

Record last verified: 2009-07

Locations

PA(1)