Ketamine for Postoperative Pain in Bariatric Surgery (KEPOBA)

The Effects of Ketamine on Postoperative Pain After Intraoperative Remifentanil Infusions in Bariatric Surgery

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain, Postoperative; Bariatric Surgery Candidate
• Intervention / Treatment: Drug: Ketamine; Drug: Ketamine; Drug: Ketamine; Drug: Ketamine; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment1; 0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.	Drug: Ketamine; 0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.; Other Names: Ketamine hydrochloride; Drug: Ketamine; 0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.; Other Names: Ketamine hydrochloride; Drug: Ketamine; 0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.; Other Names: Ketamine hydrochloride; Drug: Ketamine; 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.; Other Names: Ketamine hydrochloride
Active Comparator: Treatment2; 0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.	Drug: Ketamine; 0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.; Other Names: Ketamine hydrochloride; Drug: Ketamine; 0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.; Other Names: Ketamine hydrochloride; Drug: Ketamine; 0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.; Other Names: Ketamine hydrochloride; Drug: Ketamine; 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.; Other Names: Ketamine hydrochloride
Active Comparator: Treatment3; 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.	Drug: Ketamine; 0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.; Other Names: Ketamine hydrochloride; Drug: Ketamine; 0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.; Other Names: Ketamine hydrochloride; Drug: Ketamine; 0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.; Other Names: Ketamine hydrochloride; Drug: Ketamine; 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.; Other Names: 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 Names: Sodium chloride
Active Comparator: Treatment4; 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.	Drug: Ketamine; 0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.; Other Names: Ketamine hydrochloride; Drug: Ketamine; 0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.; Other Names: Ketamine hydrochloride; Drug: Ketamine; 0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.; Other Names: Ketamine hydrochloride; Drug: Ketamine; 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.; Other Names: Ketamine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	On the first postoperative day
Postoperative morphine requirements	Postoperative morphine requirements will be recorded in both groups in the PACU for 2.5 hours.	On the first postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of side effects	Incidence of side effects will be recorded in both groups on the first postoperative day.	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".	On the second postoperative day

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Investigators: Study Chair: Aurika Karbonskienė, MDPhDAssProf, Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2015
• Primary Completion (Actual): March 30, 2017
• Study Completion (Anticipated): June 6, 2023

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: January 1, 2018
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 13, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: BEC-MF-713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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