Ketamine for Postoperative Pain in Bariatric Surgery (KEPOBA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03389022|
Recruitment Status : Completed
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative Bariatric Surgery Candidate||Drug: Ketamine Drug: Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Ketamine on Postoperative Pain After Intraoperative Remifentanil Infusions in Bariatric Surgery|
|Actual Study Start Date :||July 22, 2015|
|Actual Primary Completion Date :||March 30, 2017|
|Actual Study Completion Date :||June 6, 2017|
Active Comparator: Treatment
0,15mg/kg (LBM) of intravenous single pre-incisional injection of ketamine given for bariatric patients in the operating room.
Intravenous injection 0,15mg/kg (LBM) given pre-incisional in the operating room.
Other Name: Ketamine hydrochloride
Placebo Comparator: Control
The same amount of intravenous single pre-incisional injection of saline for bariatric patients in the operating room.
Intravenous injection given pre-incisional in the operating room.
Other Name: Sodium chloride
- Postoperative pain intensity [ Time Frame: 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 [ Time Frame: On the first postoperative day ]Postoperative morphine requirements will be recorded in both groups in the PACU for 2.5 hours.
- Incidence of side effects [ Time Frame: 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 [ Time Frame: 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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389022
|Study Chair:||Aurika Karbonskienė, MDPhDAssProf||Lithuanian University of Health Sciences|