Ketamine for Postoperative Pain in Bariatric Surgery

Ketamine

Brief Summary

The aim of this study was to evaluate an effect of pre - incisional single injection of low-dose ketamine on postoperative pain after remifentanil infusion in patients undergoing laparoscopic gastric bypass and gastric plication surgery. Ketamine is an old general anaesthetic. Low doses of it might be used as a adjunct in postoperative analgesia.The investigators expect that the low-dose ketamine reduces postoperative pain after bariatric surgeries.

Intervention / Treatment

  • Ketamine (DRUG)
    0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
  • Saline (DRUG)
    Intravenous injection given pre-incisional in the operating room.

Condition or Disease

  • Pain, Postoperative
  • Bariatric Surgery Candidate

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Enrolling by invitation
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 64 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 22, 2015 ACTUAL
    Primary Completion: Mar 30, 2017 ACTUAL
    Completion Date: Jun 06, 2023 ESTIMATED
    Study First Posted: Jan 03, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 13, 2021

    Sponsors / Collaborators

    Lead Sponsor: Lithuanian University of Health Sciences
    Responsible Party: N/A

    Effective postoperative pain management enhances early postoperative rehabilitation and may improve outcomes of surgical treatment. New analgetic medications and combinations of these are sought for optimal analgesia with lowest possible incidence of side effects. One of the method of multimodal analgesia is a combination of opioids and adjuvant agents, such as ketamine. To our knowledge, the role of ketamine in the treatment of postoperative pain after bariatric surgeries is poorly researched. The investigators hypothesize that ketamine, acting through the N-methyl-D-aspartate receptor (NMDA) and opioid receptors, provides favourable conditions for adequate post-operative pain management.

    Participant Groups

    • 0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.

    • 0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.

    • 0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.

    • The same amount of intravenous single pre-incisional injection of saline for bariatric patients in the operating room.

    • 0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * II or III The American Society of Anesthesiologists (ASA) physical status
    * age \> 18 years
    * bariatric surgery with general remifentanil anesthesia

    Exclusion Criteria:

    * anamnesis of using opioids for the treatment of chronic pain
    * opioid dependence
    * younger than 18 years

    Primary Outcomes

    • Comparison of pain intensity will be recorded in both groups every 15 min in Post Anesthesia Care Unit (PACU) for 2.5 hours. Postoperative pain was treated with boluses of i.v. morphine (3 mg) at 3 min. intervals on request, if pain intensity exceeded the score of 5 according to the Numeric Pain Rating Scale (NPRS) (0-10). After the transfer of patient's to a regular unit, pain intensity was recorded every 6 hours.

    • Postoperative morphine requirements will be recorded in both groups in the PACU for 2.5 hours.

    Secondary Outcomes

    • Incidence of side effects will be recorded in both groups on the first postoperative day.

    • Patients' satisfaction with postoperative analgesia will be recorded in both groups on the second postoperative day.The subject could express their level of satisfaction in five possible levels, from "very satisfied" to "very dissatisfied".

    More Details

    NCT Number: NCT03389022
    Acronym: KEPOBA
    Other IDs: BEC-MF-713
    Study URL: https://clinicaltrials.gov/study/NCT03389022
    Last updated: Sep 29, 2023