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

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958513
• Other study ID #: BSMMU/2018/12652
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: May 2020
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ? -?

• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

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

Locations

Country	Name	City	State
Bangladesh	Bangabandhu Sheikh Mujib Medical University	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain: VAS	Post-operative pain in visual analog scale ranging 0 to100	12 hours
Primary	Post-operative pain: rating scale	Post-operative pain in numerical rating scale ranging 0 to 4	12 HOURS
Secondary	Patient Satisfaction Level: questionnaire	Patient Satisfaction Level is measured with revised american pain society outcome questionnaire. 12 questions are present.	24 hour
Secondary	Hospital stay	Time frame for hospital discharge	3-5 days
Secondary	Pain during hospital discharge: VAS	visual analog scale score during hospital discharge rangibg 0-100	3-5days
Secondary	Time taken to return to job and normal activities		15-30 days
Secondary	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