To Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy

Randomized, Double- Blind, Controlled Trial to Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy

To evaluate the effect of wound infiltration with 0.25% Bupivacaine in laparoscopic cholecystectomy in terms of pain severity, patient satisfaction level, quality of life, hospital stay and return to job and normal activities.

Study Overview

• Status: Completed
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: 0.9% normal saline; Drug: Bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Bangabandhu Sheikh Mujib Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria

• Patients scheduled to undergo laparoscopic cholecystectomy under general anesthesia at department of surgery and department of hepatobiliary system, BSMMU
• Patients who are eligible according to ASA Ⅰ -Ⅱ
• Female or male, age ≥18 years
• Patients who are scheduled for same anesthetic technique and surgical procedure for laparoscopic cholecystectomy
• Discharge of patient between 12 hour to 36 hour after performing procedure
• Patients given consent for enrollment in study

Exclusion criteria

• Patients known to be allergic to certain recommended drugs
• If patients have history of psychiatric illness
• Patients on chronic analgesic therapy for any other indication
• Patients who are scheduled for different anesthetic technique and surgical procedure for laparoscopic cholecystectomy
• Duration of surgery more than 1 hour
• Patients undergoing laparoscopic cholecystectomy for complex gallbladder disease such as incidental gallbladder pancreatitis, gallstone pancreatitis, cholecystoduodenal fistula, mirizzi syndrome
• Special population group such as children, pregnant woman, patients with cirrhosis, diabetics
• Duration of operative procedure more than 1 hour

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 0.9% normal saline, 1.5 ml for 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy	Drug: 0.9% normal saline; 1.5 ml 0.9% NACl for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy
Experimental: Intervention; 0.25% Bupivacaine, 1.5 ml per 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy	Drug: Bupivacaine; 1.5 ml 0.25% bupivacaine for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain: VAS	Post-operative pain in visual analog scale ranging 0 to100	12 hours
Post-operative pain: rating scale	Post-operative pain in numerical rating scale ranging 0 to 4	12 HOURS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Level: questionnaire	Patient Satisfaction Level is measured with revised american pain society outcome questionnaire. 12 questions are present.	24 hour
Hospital stay	Time frame for hospital discharge	3-5 days
Pain during hospital discharge: VAS	visual analog scale score during hospital discharge rangibg 0-100	3-5days
Time taken to return to job and normal activities		15-30 days
Assesment of quality of life: index	Quality of life is measured with gastrointestinal quality of life index. there are 36 questions . it will measure quality of life after surgery.	15th and 30th post-operative day

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: BSMMU/2018/12652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No