IV and Intrathecal Ketamine in Cesarean Section

Ketamine

Brief Summary

In the current study, the investigators will compare the effects of low-dose intravenous (i.v.) ketamine versus intrathecal Ketamine added to spinal anesthesia on the time to first request for analgesia and maternal pain scores and overall satisfaction in patients undergoing cesarean section.

Intervention / Treatment

  • intrathecal ketamine (DRUG)
    Patients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine
  • Intravenous ketamine (DRUG)
    Patients will receive IV Ketamine 0.25mg/kg after spinal

Condition or Disease

  • Cesarean Section
  • Analgesia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Not yet recruiting
    Study results: No Results Available
    Age: 18 Years to 45 Years
    Enrollment: 60 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 01, 2023 ESTIMATED
    Primary Completion: Mar 01, 2024 ESTIMATED
    Completion Date: Mar 01, 2025 ESTIMATED
    Study First Posted: Jan 11, 2023 ACTUAL
    Last Updated: Dec 24, 2022

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Participant Groups

    • Patients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine.

    • Patients will receive IV Ketamine 0.25mg/kg after spinal anesthesia with bupivacaine and morphine.

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 45
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion criteria:

    • Pregnant undergoing elective cesarean section

    Exclusion Criteria

    * Significant coexisting diseases (pregnancy-induced hypertension or diabetes)
    * body mass index ≥40kg/m2, height \<150cm
    * Current use of pain medication including opioids
    * history of substance abuse or hallucinations, cardiovascular disease, diabetes, multiple gestations
    * chronic pain was excluded.
    * contraindications to spinal anaesthesia,
    * severely compromised fetus requiring general anesthesia and those patients who received labor analgesia

    Primary Outcomes
    • Time to the first analgesic request First Postoperative day
    Secondary Outcomes
    • Postoperative pain scores NRS at rest and on movement; (2, 4, 6, 12, and 24 hours) postoperative first postoperative day

    More Details

    NCT Number: NCT05679375
    Other IDs: Ketamine in Cesarean section
    Study URL: https://clinicaltrials.gov/study/NCT05679375
    Last updated: Sep 29, 2023