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

NCT03958513 | Completed Phase 2

• 1 other identifier: BSMMU/2018/12652
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Patient Satisfaction Level: questionnaire

  24 hour

• Hospital stay

  3-5 days

• Pain during hospital discharge: VAS

  3-5days

• Time taken to return to job and normal activities

  15-30 days

• Assesment of quality of life: index

  15th and 30th post-operative day

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Intervention

EXPERIMENTAL

0.25% Bupivacaine, 1.5 ml per 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

1.5 ml 0.25% bupivacaine for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy

Intervention

0.9% normal saline DRUG

1.5 ml 0.9% NACl for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 22, 2019
• Study Start: January 1, 2019
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)