intrathecaم Ketamine, Morphine and Both for Lower Abdominal Cancer Surgery Pain

Ketamine

Brief Summary

this study investigates the analgesic efficacy and other possible effects of ketamine, morphine, and both together when administered intrathecally for control of postoperative pain following lower abdominal cancer surgeries.

Intervention / Treatment

  • intrathecal morphine (DRUG)
    patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg intrathecal morphine1 ml volume.
  • intrathecal ketamine (DRUG)
    patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg intrathecal ketamine in 1ml volume.
  • intrathecal morphine + ketamine (DRUG)
    patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and intrathecal morphine + ketamine 0.3 mg and 0.1 mg/kg respectively in 1 ml volume.

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 30 Years to 50 Years
    Enrollment: 90 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Oct 01, 2015
    Primary Completion: Feb 01, 2016 ACTUAL
    Completion Date: Apr 01, 2016 ACTUAL
    Study First Posted: Apr 04, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 25, 2017

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Participant Groups

    • patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine in 1 ml volume intrathecally.

    • patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume intrathecally.

    • patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine plus 0.1 mg/kg of Ketamine in 1 ml volume intrathecally.

    Eligibility Criteria

    Sex: All
    Minimum Age: 30
    Maximum Age: 50
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * American Society of Anesthesia (ASA) I-III patients.
    * aged 30-50 years.
    * scheduled for major abdominal cancer surgery.

    Exclusion Criteria:

    * Patients with a known allergy to the study drugs.
    * significant cardiac, respiratory, renal or hepatic disease.
    * coagulation disorders.
    * infection at or near the site of intrathecal injection.
    * drug or alcohol abuse.
    * BMI \> 30 kg/m2.
    * psychiatric illnesses that may interfere with perception and assessment of pain.

    Primary Outcomes

    • postoperative pain measured by this score.

    • the time passed till the first request of rescue analgesia by the patients

    • the total amount of rescue analgesic drug used allover follow up period

    Secondary Outcomes

    • the type and rate of incidence of side effects during the follow up period

    More Details

    NCT Number: NCT02726828
    Other IDs: 165
    Study URL: https://clinicaltrials.gov/study/NCT02726828
    Last updated: Sep 29, 2023