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Effectiveness of Port Site Bupivacaine Injection in Postoperative Pain Reduction After Lap. Chole

Sponsor
Hamdard University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05264805
Collaborator
(none)
166
Enrollment
2
Arms
6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.25% Bupivacaine
 Phase 3

Detailed Description

The study is being done to determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
166 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 interventionGroup 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)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial of Port Site Subcutaneous Injection of Bupivacaine to Determine the Effectiveness of Postoperative Pain Relief After Laparoscopic Cholecystectomy
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bupivacaine group

Patient receiving 20ml of inj. 0.25% Bupivacaine at laparoscopic port site

Drug: 0.25% Bupivacaine
20ml of 0.25% Bupivacaine subcutaneous infiltration at port site wound.
Other Names:
  • Bupivacain

    		•
    No Intervention: Placebo group

    No drug infiltration at laparoscopic port site

    Outcome Measures

    Primary Outcome Measures

    1. Post laparoscopic port site pain assessment [Pain assessment from 0hour (patient received in recovery room) till 12hours postoperatively at interval of 3hours i.e. 0,3,6,9,12 hour]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Patients of both the gender of age >18 years and <45years

    2. Patients undergoing elective laparoscopic cholecystectomy under general anesthesia.

    3. Patients with A.S.A grade I and II.

    Exclusion Criteria:

    1. Patients with known allergic reactions to local anesthetics.

    2. Patients converted to open procedure.

    3. Patients developing intra-operative complications.

    4. Patients undergoing for laparoscopic cholecystectomy for acute cholecystitis.

    5. Patients with obesity and chronic illness.

    6. Patients with history of opioids, steroids, NSAIDs and alcohol use.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hamdard University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Nida Shahid, Assistant Professor, Hamdard University
    ClinicalTrials.gov Identifier:
    NCT05264805
    Other Study ID Numbers:
    • N0333
    First Posted:
    Mar 3, 2022
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Mar 1, 2022
    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
    Keywords provided by Dr. Nida Shahid, Assistant Professor, Hamdard University
    #Post operative pain
    #laparoscopic cholecystectomy
    Additional relevant MeSH terms:
    Pain, Postoperative
    Bupivacaine

    Study Results

    No Results Posted as of Mar 3, 2022