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Venlafaxine for Postoperative Pain of Laparoscopic Cholecystectomy

Primary Purpose

Laparoscopic Cholecystectomy

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Venlafaxine
Placebo
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Cholecystectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Patients who are scheduled to undergo elective LC Exclusion Criteria: 1- Patients with acute pancreatitis 2. Patients undergoing chronic pain treatment 3. Patients who received analgesics or sedatives 24 h before scheduled surgery 3. Patients had alcohol or drug addiction 4. Severe hepatic and renal dysfunction 5. Previous allergic response to duloxetine 6. Pregnancy and lactation 7. Patients with communication problems, cognitive dysfunction, or psychological disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Laparoscopic Cholecystectomy

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in postoperative pain between the two groups using visual analogue score (VAS)
    pain will be assessed using visual analogue score (VAS) 0-100 mm (0 indicated no pain, 100 denoted the most severe pain) pain will be assessed using visual analogue score (VAS) 0-100 mm (0 indicated no pain, 100 denoted the most severe pain)

    Secondary Outcome Measures

    Postoperative nausea and vomiting (PONV)
    will be assessed using PONV scale a 4-point scale: none (0): no nausea, vomiting, and retching; mild (1): happened once; moderate (2): happened 2-3 times; and severe (3): continuous or more than three times.

    Full Information

    First Posted
    May 22, 2023
    Last Updated
    May 22, 2023
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05884268
    Brief Title
    Venlafaxine for Postoperative Pain of Laparoscopic Cholecystectomy
    Official Title
    Evaluating Safety and Tolerability of Venlafaxine for Postoperative Pain of Laparoscopic Cholecystectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 30, 2023 (Anticipated)
    Primary Completion Date
    January 30, 2024 (Anticipated)
    Study Completion Date
    January 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Recent studies on the impact of perioperative venlafaxine for treatment of acute postoperative pain have yielded positive outcomes . The aim of the present study is to investigate the role of perioperative venlafaxine on the management of postoperative pain in patients undergoing LC.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Laparoscopic Cholecystectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Laparoscopic Cholecystectomy
    Arm Type
    Active Comparator
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Venlafaxine
    Intervention Description
    Patients scheduled for elective LC will receive 150 mg venlafaxine before surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Patients scheduled for elective LC will receive placebo venlafaxine before surgery
    Primary Outcome Measure Information:
    Title
    Change in postoperative pain between the two groups using visual analogue score (VAS)
    Description
    pain will be assessed using visual analogue score (VAS) 0-100 mm (0 indicated no pain, 100 denoted the most severe pain) pain will be assessed using visual analogue score (VAS) 0-100 mm (0 indicated no pain, 100 denoted the most severe pain)
    Time Frame
    24 Hours postoperative
    Secondary Outcome Measure Information:
    Title
    Postoperative nausea and vomiting (PONV)
    Description
    will be assessed using PONV scale a 4-point scale: none (0): no nausea, vomiting, and retching; mild (1): happened once; moderate (2): happened 2-3 times; and severe (3): continuous or more than three times.
    Time Frame
    24 Hours postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Patients who are scheduled to undergo elective LC Exclusion Criteria: 1- Patients with acute pancreatitis 2. Patients undergoing chronic pain treatment 3. Patients who received analgesics or sedatives 24 h before scheduled surgery 3. Patients had alcohol or drug addiction 4. Severe hepatic and renal dysfunction 5. Previous allergic response to duloxetine 6. Pregnancy and lactation 7. Patients with communication problems, cognitive dysfunction, or psychological disorders

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Venlafaxine for Postoperative Pain of Laparoscopic Cholecystectomy

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