Ketamine for Postoperative Pain in Bariatric Surgery

Pain, Postoperative Clinical Trial

— KEPOBA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03389022
• Other study ID #: BEC-MF-713
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: July 22, 2015
• Est. completion date: June 6, 2023

Study information

• Verified date: November 2021
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 64
• Est. completion date: June 6, 2023
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Pain, Postoperative

Intervention

Drug:
• Ketamine
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
• Saline
Intravenous injection given pre-incisional in the operating room.
• Ketamine
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
• Ketamine
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Incidence of side effects	Incidence of side effects will be recorded in both groups on the first postoperative day.	On the first postoperative day
Secondary	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