Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

Ketamine

Brief Summary

Postoperative abdominal and shoulder pain that are experienced in patients undergoing laparoscopic cholecystectomy (LC) is significant. Although it is generally less sever than post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours postoperatively

Intervention / Treatment

  • Bupivacaine (DRUG)
    instillation of local anaesthetic in the abdominal cavity at the end of the procedure
  • isotonic saline (DRUG)
    instillation of local anaesthetic in the abdominal cavity at the end of the procedure
  • Bupivacaine + morphine (DRUG)
    instillation of local anaesthetic + morphine sulfate in the abdominal cavity at the end of the procedure
  • Bupivacaine + morphine + ketamine (DRUG)
    instillation of local anaesthetic + morphine sulfate + ketamine in the abdominal cavity at the end of the procedure

Condition or Disease

  • Perioperative Pain

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 55 Years
    Enrollment: 110 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Oct 24, 2020 ACTUAL
    Primary Completion: Mar 01, 2021 ACTUAL
    Completion Date: Mar 30, 2021 ACTUAL
    Study First Posted: Oct 30, 2020 ACTUAL
    Last Updated: Aug 27, 2021

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Location

    Asyut, Egypt

    The incidence of pain after laparoscopy may be as high as 36 to 63 percent and is attributed to the carbon dioxide gas (CO2) used to induce pneumo-peritoneum1.

    The residual part of CO2 remains in the peritoneal cavity for several days after the operation and causes stretching of the phrenic nerve endings, local hypothermia, and diaphragmatic irritation by carbonic acid formation

    Participant Groups

    • No description provided

    • No description provided

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 55
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Patients scheduled for Laparoscopic cholecystectomy.
    * Age spectrum of 18 - 55 years
    * ASA I, II
    * Have no comorbid chronic medical diseases

    Exclusion Criteria:

    * Patients with co morbid medical diseases
    * Age outside the specified range
    * Acute inflammation of the gall bladder
    * Critically ill patient
    * Emergency operations
    * Patient refusal

    Primary Outcomes

    • a stress marker that increase with pain and surgery

    Secondary Outcomes

    • to assess postoperative pain

    More Details

    NCT Number: NCT04609033
    Other IDs: 17300477
    Study URL: https://clinicaltrials.gov/study/NCT04609033
    Last updated: Sep 29, 2023