Intraperitoneal Analgesia After Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Postoperative Pain After Instillation Of Bupivacaine During Laparoscopic Cholecystectomy

NCT07098429

Laparoscopic Cholecystectomy Post Operative Analgesia Bupivacaine

COMPLETED PHASE4

Intraperitoneal Ketamine Versus Bupivacaine for Postoperative Pain Control After Laparoscopic Cholecystectomy

NCT06807554

Laparoscopic Cholecystectomy Surgery

COMPLETED EARLY_PHASE1

Comparison of Intraoperative Intravenous Lidocaine Infusion and Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia Following Laproscopic Cholecystectomy

NCT05231941

Post Operative Pain

COMPLETED NA

Lidocaine and Analgesia After Laparoscopic Cholecystectomy

NCT03620591

Postoperative Pain Opioid Consumption

COMPLETED NA

Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

NCT04609033

Perioperative Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laparoscopic Cholecystectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intraperitoneal lignocaine

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

Group Type ACTIVE_COMPARATOR

lignocaine

Intervention Type DRUG

200 mg of intraperitoneal lignocaine will be given once during surgery

bupevacaine

Intervention Type DRUG

100 mg of bupevacaine will be given once during laparoscopic cholecystectomy

intraperitoneal bupevacaine

intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine after laparoscopic cholecystectomy

Group Type ACTIVE_COMPARATOR

lignocaine

Intervention Type DRUG

200 mg of intraperitoneal lignocaine will be given once during surgery

bupevacaine

Intervention Type DRUG

100 mg of bupevacaine will be given once during laparoscopic cholecystectomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lignocaine

200 mg of intraperitoneal lignocaine will be given once during surgery

Intervention Type DRUG

bupevacaine

100 mg of bupevacaine will be given once during laparoscopic cholecystectomy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No