Local Ketamine Instillation for Postoperative Analgesia

Ketamine

Brief Summary

This study aims at exploring the analgesic efficacy, and safety of Ketamine instillation into the wound of total thyroidectomy compared to placebo,and to systemic ketamine administration (I.M. injection of the same dose) with respect to postoperative VAS, first request of analgesia, total opioid consumption, and with respect to possible side effects.

Intervention / Treatment

  • intra-wound instillation of ketamine (DRUG)
    intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure
  • intra-wound instillation of normal saline (DRUG)
    intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure
  • systemic administration of ketamine (DRUG)
    intra-muscular administration of ketamine (1 mg/ kg), given before wound closure.

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 60 Years
    Enrollment: 90 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Aug 01, 2015
    Primary Completion: Feb 01, 2016 ACTUAL
    Completion Date: Dec 01, 2016 ACTUAL
    Study First Posted: Dec 30, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 01, 2017

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Participant Groups

    • intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.

    • intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.

    • Intra-muscular injection of ketamine at a dose of 1 mg/kg before wound closure.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 60
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * patients with thyroid cancer scheduled for total thyroidectomy.

    Exclusion Criteria:

    1. BMI\>35
    2. Unstable ischaemic cardiac disease
    3. Increased intracranial pressure
    4. Increased intraocular pressure
    5. Hypersensitivity or allergy to ketamine, local anesthetic, morphine, or other drugs used in the study.
    6. Severe psychiatric disease
    7. Unwillingness or inability to use PCA-device
    8. Inability to use VAS scale

    Primary Outcomes

    • the total amount of morphine consumed during follow up period

    Secondary Outcomes

    • time to first request of rescue analgesic drug

    • effect of study drugs on postoperative pain measured by VAS score

    Other Outcomes

    • occurrence of possible side effects during follow up

    More Details

    NCT Number: NCT02642497
    Other IDs: 342
    Study URL: https://clinicaltrials.gov/study/NCT02642497
    Last updated: Sep 29, 2023