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Ketamine for Postoperative Pain in Bariatric Surgery (KEPOBA)

Primary Purpose

Pain, Postoperative, Bariatric Surgery Candidate

Status
Enrolling by invitation
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketamine
Saline
Ketamine
Ketamine
Ketamine
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Active Comparator

    Arm Label

    Treatment1

    Treatment2

    Treatment3

    Control

    Treatment4

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Incidence of side effects
    Incidence of side effects will be recorded in both groups on the first postoperative day.
    Patients' satisfaction with postoperative analgesia
    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".

    Full Information

    First Posted
    December 14, 2017
    Last Updated
    November 13, 2021
    Sponsor
    Lithuanian University of Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03389022
    Brief Title
    Ketamine for Postoperative Pain in Bariatric Surgery
    Acronym
    KEPOBA
    Official Title
    The Effects of Ketamine on Postoperative Pain After Intraoperative Remifentanil Infusions in Bariatric Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Enrolling by invitation
    Study Start Date
    July 22, 2015 (Actual)
    Primary Completion Date
    March 30, 2017 (Actual)
    Study Completion Date
    June 6, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lithuanian University of Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative, Bariatric Surgery Candidate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment1
    Arm Type
    Active Comparator
    Arm Description
    0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.
    Arm Title
    Treatment2
    Arm Type
    Active Comparator
    Arm Description
    0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.
    Arm Title
    Treatment3
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    The same amount of intravenous single pre-incisional injection of saline for bariatric patients in the operating room.
    Arm Title
    Treatment4
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Other Intervention Name(s)
    Ketamine hydrochloride
    Intervention Description
    0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
    Intervention Type
    Drug
    Intervention Name(s)
    Saline
    Other Intervention Name(s)
    Sodium chloride
    Intervention Description
    Intravenous injection given pre-incisional in the operating room.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Other Intervention Name(s)
    Ketamine hydrochloride
    Intervention Description
    0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Other Intervention Name(s)
    Ketamine hydrochloride
    Intervention Description
    0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Other Intervention Name(s)
    Ketamine hydrochloride
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Postoperative pain intensity
    Description
    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.
    Time Frame
    On the first postoperative day
    Title
    Postoperative morphine requirements
    Description
    Postoperative morphine requirements will be recorded in both groups in the PACU for 2.5 hours.
    Time Frame
    On the first postoperative day
    Secondary Outcome Measure Information:
    Title
    Incidence of side effects
    Description
    Incidence of side effects will be recorded in both groups on the first postoperative day.
    Time Frame
    On the first postoperative day
    Title
    Patients' satisfaction with postoperative analgesia
    Description
    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".
    Time Frame
    On the second postoperative day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aurika Karbonskienė, MDPhDAssProf
    Organizational Affiliation
    Lithuanian University of Health Sciences
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Ketamine for Postoperative Pain in Bariatric Surgery

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