Back to resultsEffectiveness of Port Site Bupivacaine Injection in Postoperative Pain Reduction After Lap. Chole
Primary Purpose
Pain, Postoperative
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
0.25% Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring #Post operative pain, #laparoscopic cholecystectomy
Eligibility Criteria
Inclusion Criteria:
- Patients of both the gender of age >18 years and <45years
- Patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
- Patients with A.S.A grade I and II.
Exclusion Criteria:
- Patients with known allergic reactions to local anesthetics.
- Patients converted to open procedure.
- Patients developing intra-operative complications.
- Patients undergoing for laparoscopic cholecystectomy for acute cholecystitis.
- Patients with obesity and chronic illness.
- Patients with history of opioids, steroids, NSAIDs and alcohol use.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bupivacaine group
Placebo group
Arm Description
Patient receiving 20ml of inj. 0.25% Bupivacaine at laparoscopic port site
No drug infiltration at laparoscopic port site
Outcomes
Primary Outcome Measures
Post laparoscopic port site pain assessment
Pain assessment by "Visual Analog Scoring system" scoring from 0 to 10, where 0 means no pain and 10 means worst possible, unbearable excruciating pain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05264805
Brief Title
Effectiveness of Port Site Bupivacaine Injection in Postoperative Pain Reduction After Lap. Chole
Official Title
A Randomized Controlled Trial of Port Site Subcutaneous Injection of Bupivacaine to Determine the Effectiveness of Postoperative Pain Relief After Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamdard University
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.
Detailed Description
The study is being done to determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
#Post operative pain, #laparoscopic cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Group A:
Study group: Patient receiving intervention i.e 20ml of 0.25% buvivacaine infiltration at laparoscopic port site.
Group B:
Control group: no intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine group
Arm Type
Experimental
Arm Description
Patient receiving 20ml of inj. 0.25% Bupivacaine at laparoscopic port site
Arm Title
Placebo group
Arm Type
No Intervention
Arm Description
No drug infiltration at laparoscopic port site
Intervention Type
Drug
Intervention Name(s)
0.25% Bupivacaine
Other Intervention Name(s)
Bupivacain
Intervention Description
20ml of 0.25% Bupivacaine subcutaneous infiltration at port site wound.
Primary Outcome Measure Information:
Title
Post laparoscopic port site pain assessment
Description
Pain assessment by "Visual Analog Scoring system" scoring from 0 to 10, where 0 means no pain and 10 means worst possible, unbearable excruciating pain.
Time Frame
Pain assessment from 0hour (patient received in recovery room) till 12hours postoperatively at interval of 3hours i.e. 0,3,6,9,12 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients of both the gender of age >18 years and <45years
Patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
Patients with A.S.A grade I and II.
Exclusion Criteria:
Patients with known allergic reactions to local anesthetics.
Patients converted to open procedure.
Patients developing intra-operative complications.
Patients undergoing for laparoscopic cholecystectomy for acute cholecystitis.
Patients with obesity and chronic illness.
Patients with history of opioids, steroids, NSAIDs and alcohol use.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Nida Shahid, MBBS, FCPS
Phone
+923332358698
Email
nida-shahid2011@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Port Site Bupivacaine Injection in Postoperative Pain Reduction After Lap. Chole
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