Ketamine for Postoperative Pain in Bariatric Surgery

NCT03389022 | Unknown Phase 4

• 1 other identifier: BEC-MF-713
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Incidence of side effects

  On the first postoperative day

• Patients' satisfaction with postoperative analgesia

  On the second postoperative day

Study Arms (5)

Treatment1

ACTIVE COMPARATOR

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

Drug: Ketamine

Treatment2

ACTIVE COMPARATOR

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

Drug: Ketamine

Treatment3

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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

Drug: Saline

Treatment4

ACTIVE COMPARATOR

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

Interventions

Ketamine DRUG

0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.

Also known as: Ketamine hydrochloride

Treatment1

Saline DRUG

Intravenous injection given pre-incisional in the operating room.

Also known as: Sodium chloride

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Aurika Karbonskienė, MDPhDAssProf

  Lithuanian University of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 3, 2018
• Study Start: July 22, 2015
• Primary Completion: March 30, 2017
• Study Completion: June 6, 2023
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share