Ketamine for Postoperative Pain in Bariatric Surgery
- Conditions
- Bariatric Surgery CandidatePain, Postoperative
- Interventions
- Drug: Saline
- Registration Number
- NCT03389022
- Lead Sponsor
- Lithuanian University of Health Sciences
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
- II or III The American Society of Anesthesiologists (ASA) physical status
- age > 18 years
- bariatric surgery with general remifentanil anesthesia
- anamnesis of using opioids for the treatment of chronic pain
- opioid dependence
- younger than 18 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Saline The same amount of intravenous single pre-incisional injection of saline for bariatric patients in the operating room. Treatment1 Ketamine 0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room. Treatment2 Ketamine 0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room. Treatment3 Ketamine 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. Treatment4 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.
- Primary Outcome Measures
Name Time Method Postoperative pain intensity 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.
Postoperative morphine requirements On the first postoperative day Postoperative morphine requirements will be recorded in both groups in the PACU for 2.5 hours.
- Secondary Outcome Measures
Name Time Method Incidence of side effects On the first postoperative day Incidence of side effects will be recorded in both groups on the first postoperative day.
Patients' satisfaction with postoperative analgesia 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".