Ketamine for Postoperative Pain in Bariatric Surgery (KEPOBA)

• ClinicalTrials.gov Identifier: NCT03389022
• Recruitment Status: Enrolling by invitation
• First Posted: January 3, 2018
• Last Update Posted: November 22, 2021
• Sponsor: Lithuanian University of Health Sciences
• Information provided by (Responsible Party): Greta Kasputytė, Lithuanian University of Health Sciences

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 64 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
• Estimated Study Completion Date: June 6, 2023

Arms and Interventions

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 Name: 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; 0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.; Other Name: 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, followed by continuous infusion of 1 mg/kg 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
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; 0,3 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 Name: Ketamine hydrochloride

Outcome Measures

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".

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

Lithuanian University of Health Sciences

Investigators

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

More Information

• Responsible Party: Greta Kasputytė, MD, Lithuanian University of Health Sciences
• ClinicalTrials.gov Identifier: NCT03389022
• Other Study ID Numbers: BEC-MF-713
• First Posted: January 3, 2018
• Last Update Posted: November 22, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; 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