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Intravenous Ketamine and Postoperative Pain Following Cesarean Section.

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03018301
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
9
Duration (Months)
8.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

  • 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Single Intravenous Ketamine Dose on Postoperative Pain Following Cesarean Section Under Spinal Anesthesia: A Randomized Control Clinical Trial.
Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Oct 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ketamine group

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

Drug: Ketamine
will receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.
Other Names:
  • Ketalar

    		•
    Placebo Comparator: Control group

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

    Other: Normal saline
    will receive intravenous 20 ml of normal saline, delivered over 10 minutes.

    Outcome Measures

    Primary Outcome Measures

    1. • Number of Subjects Requiring Supplemental Analgesia [24 hours postoperative]

    Secondary Outcome Measures

    1. Cumulative morphine/paracetamol [24 hours postoperative]

    2. Number of subjects reporting nausea, vomiting [24 hours postoperative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university faculty of medicine Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Chair: Israa M Sayed, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Abdelrady S Ibrahim, MD, Assistant professor of anesthesia and ICU, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03018301
    Other Study ID Numbers:
    • IRB0000871238
    First Posted:
    Jan 12, 2017
    Last Update Posted:
    Jan 12, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Pain, Postoperative
    Ketamine

    Study Results

    No Results Posted as of Jan 12, 2017