Ketamine for Postoperative Pain in Bariatric Surgery (KEPOBA)

Lithuanian University of Health Sciences

Status and phase: Unknown; Phase 4

Conditions: Bariatric Surgery Candidate; Pain, Postoperative

Treatments: Drug: Saline; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03389022

BEC-MF-713

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 5 patient groups, including a placebo group

Treatment1

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine

Drug: Ketamine

Drug: Ketamine

Drug: Ketamine

Treatment2

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine

Drug: Ketamine

Drug: Ketamine

Drug: Ketamine

Treatment3

Active Comparator group

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.

Treatment:

Drug: Ketamine

Drug: Ketamine

Drug: Ketamine

Drug: Ketamine

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline

Treatment4

Active Comparator group

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.

Treatment:

Drug: Ketamine

Drug: Ketamine

Drug: Ketamine

Drug: Ketamine