KEPOBA: Ketamine for Postoperative Pain in Bariatric Surgery
Study Details
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 |
|---|---|---|
| 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
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 Names:
|
| 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 Names:
|
| 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 Names:
|
| 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 Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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".
Eligibility Criteria
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
Locations
No locations specified.Sponsors and Collaborators
- Lithuanian University of Health Sciences
Investigators
- Study Chair: Aurika Karbonskienė, MDPhDAssProf, Lithuanian University of Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BEC-MF-713