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

Phase 2

Completed

• Conditions: Post-operative Pain
• Interventions: Drug: 0.9% normal saline; Drug: Bupivacaine

• Registration Number: NCT03958513
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-22
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-29
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	0.9% normal saline	0.9% normal saline, 1.5 ml for 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy
Intervention	Bupivacaine	0.25% Bupivacaine, 1.5 ml per 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy

Primary Outcome Measures

Name	Time	Method
Post-operative pain: VAS	12 hours	Post-operative pain in visual analog scale ranging 0 to100
Post-operative pain: rating scale	12 HOURS	Post-operative pain in numerical rating scale ranging 0 to 4

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bangabandhu Sheikh Mujib Medical University; 🇧🇩 Dhaka, Bangladesh