Back to resultsTo Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy
Primary Purpose
Post-operative Pain
Status
Completed
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Bupivacaine
0.9% normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain
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
Sites / Locations
- Bangabandhu Sheikh Mujib Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Intervention
Arm Description
0.9% normal saline, 1.5 ml for 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy
0.25% Bupivacaine, 1.5 ml per 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy
Outcomes
Primary Outcome Measures
Post-operative pain: VAS
Post-operative pain in visual analog scale ranging 0 to100
Post-operative pain: rating scale
Post-operative pain in numerical rating scale ranging 0 to 4
Secondary Outcome Measures
Patient Satisfaction Level: questionnaire
Patient Satisfaction Level is measured with revised american pain society outcome questionnaire. 12 questions are present.
Hospital stay
Time frame for hospital discharge
Pain during hospital discharge: VAS
visual analog scale score during hospital discharge rangibg 0-100
Time taken to return to job and normal activities
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.
Full Information
NCT ID
NCT03958513
First Posted
May 15, 2019
Last Updated
May 29, 2020
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT03958513
Brief Title
To Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy
Official Title
Randomized, Double- Blind, Controlled Trial to Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% normal saline, 1.5 ml for 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy
Arm Title
Intervention
Arm Type
Experimental
Arm Description
0.25% Bupivacaine, 1.5 ml per 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
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
Intervention Name(s)
0.9% normal saline
Intervention Description
1.5 ml 0.9% NACl for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
Post-operative pain: VAS
Description
Post-operative pain in visual analog scale ranging 0 to100
Time Frame
12 hours
Title
Post-operative pain: rating scale
Description
Post-operative pain in numerical rating scale ranging 0 to 4
Time Frame
12 HOURS
Secondary Outcome Measure Information:
Title
Patient Satisfaction Level: questionnaire
Description
Patient Satisfaction Level is measured with revised american pain society outcome questionnaire. 12 questions are present.
Time Frame
24 hour
Title
Hospital stay
Description
Time frame for hospital discharge
Time Frame
3-5 days
Title
Pain during hospital discharge: VAS
Description
visual analog scale score during hospital discharge rangibg 0-100
Time Frame
3-5days
Title
Time taken to return to job and normal activities
Time Frame
15-30 days
Title
Assesment of quality of life: index
Description
Quality of life is measured with gastrointestinal quality of life index. there are 36 questions . it will measure quality of life after surgery.
Time Frame
15th and 30th post-operative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Bangabandhu Sheikh Mujib Medical University
City
Dhaka
Country
Bangladesh
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy
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