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

NCT ID: NCT03958513

Last Updated: 2020-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

0.9% normal saline, 1.5 ml for 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy

Group Type: PLACEBO_COMPARATOR

0.9% normal saline

Intervention Type: DRUG

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

Intervention

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

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

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

Interventions

Bupivacaine

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Dr. Monira Parveen

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bangabandhu Sheikh Mujib Medical University

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

BSMMU/2018/12652

Identifier Type: -

Identifier Source: org_study_id