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Ketamine for Postoperative Pain in Bariatric Surgery (KEPOBA)

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ClinicalTrials.gov Identifier: NCT03389022
Recruitment Status : Completed
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Greta Kasputytė, Lithuanian University of Health Sciences

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Bariatric Surgery Candidate Drug: Ketamine Drug: Saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Ketamine on Postoperative Pain After Intraoperative Remifentanil Infusions in Bariatric Surgery
Actual Study Start Date : July 22, 2015
Actual Primary Completion Date : March 30, 2017
Actual Study Completion Date : June 6, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Treatment
0,15mg/kg (LBM) of intravenous single pre-incisional injection of ketamine given for bariatric patients in the operating room.
Drug: Ketamine
Intravenous injection 0,15mg/kg (LBM) given pre-incisional in the operating room.
Other Name: Ketamine hydrochloride

Placebo Comparator: Control
The same amount of intravenous single pre-incisional injection of saline for bariatric patients in the operating room.
Drug: Saline
Intravenous injection given pre-incisional in the operating room.
Other Name: Sodium chloride




Primary Outcome Measures :
  1. Postoperative pain intensity [ Time Frame: On the first postoperative day ]
    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.

  2. Postoperative morphine requirements [ Time Frame: On the first postoperative day ]
    Postoperative morphine requirements will be recorded in both groups in the PACU for 2.5 hours.


Secondary Outcome Measures :
  1. Incidence of side effects [ Time Frame: On the first postoperative day ]
    Incidence of side effects will be recorded in both groups on the first postoperative day.

  2. Patients' satisfaction with postoperative analgesia [ Time Frame: On the second 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".



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389022


Sponsors and Collaborators
Lithuanian University of Health Sciences
Investigators
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Study Chair: Aurika Karbonskienė, MDPhDAssProf Lithuanian University of Health Sciences

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Responsible Party: Greta Kasputytė, MD, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT03389022     History of Changes
Other Study ID Numbers: BEC-MF-713
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action