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

Study Overview
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Brief Summary
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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.

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

Conditions
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Post-operative Pain

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: 0.9% normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |