Intravenous Ketamine and Postoperative Pain Following Cesarean Section.

Ketamine

Brief Summary

The purpose of this study is to investigate the analgesic effect of low-dose intravenous ketamine in pregnant mothers undergoing cesarean section under Bupivacaine spinal anesthesia.

Intervention / Treatment

  • Ketamine (DRUG)
    will receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.
  • Normal saline (OTHER)
    will receive intravenous 20 ml of normal saline, delivered over 10 minutes.

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 40 Years
    Enrollment: 80 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Jan 01, 2017
    Primary Completion: Jun 01, 2017 ESTIMATED
    Completion Date: Oct 01, 2017 ESTIMATED
    Study First Posted: Jan 12, 2017 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 10, 2017

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Location

    Asyut, Egypt

    * No premedication will be given, and patients will be monitored by electrocardiogram, non-invasive arterial blood pressure, and pulse oximetry when they entered the operating room.
    * 18 gauge IV cannula will be inserted and all patients will be preloaded with 10 ml/kg of lactate ringer over 20 min period.
    * All participants will have spinal anesthesia using bupivacaine. The dose of the drug, as well as the method of injection will be identical for all individuals; 10 mg (2 cc 0.5%), in the L4-L5 space using needle 25 G, midline, with the patient in a sitting position.
    * After administering bupivacaine, and prior to surgery the height of the sensory block will be assessed bilaterally (complete loss of sensation to ice) in a ascending fashion starting from T12 dermatome.
    * Once adequate anesthesia to at least T6 dermatome will be achieved, the operation will be allowed to begin. When systolic blood pressure decrease to \< 90 mmHg, or 30% of the pre-anesthetic blood pressure, it will be corrected by administering 5 mg ephedrine.
    * Patients will be asked to report any intraoperative pain using visual pain score(VPS)of 0(no pain) 10(worst pain).

    Participant Groups

    • will receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.

    • will receive intravenous 20 ml of normal saline, delivered over 10 minutes.

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 40
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Eligible women ASA class 1 and 2, are at term (≥37 week gestation), Scheduled for elective cesarean section whose anesthetic plan is for spinal anesthesia with Bupivacaine and intravenous pethidine and paracetamol for post operative analgesia.

    Exclusion Criteria:

    * • Body mass index ≥40 kg/m2,

    * Known allergy to any of the study medications,
    * Contraindication to the spinal anesthesia,
    * History of substance abuse,
    * History of hallucinations,
    * Chronic opioid therapy,
    * Chronic pain.

    Primary Outcomes
    • • Number of Subjects Requiring Supplemental Analgesia 24 hours postoperative
    Secondary Outcomes
    • Cumulative morphine/paracetamol 24 hours postoperative
    • Number of subjects reporting nausea, vomiting 24 hours postoperative

    More Details

    NCT Number: NCT03018301
    Other IDs: IRB0000871238
    Study URL: https://clinicaltrials.gov/study/NCT03018301
    Last updated: Sep 29, 2023