Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia After Back Surgery.
|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: NCT03036514|
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : March 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Device: Sublingual sufentanil tablet system Drug: Patient-controlled intravenous analgesia||Not Applicable|
Sublingual sufentanil tablet system (SSTS) is compared in pain relief and side effect profile with the routinely used intravenous patient controlled analgesia (PCIA) with morphine in the postoperative phase after back surgery. The common use of PCIA with morphine is associated with a rather slow onset-time and active metabolites, with occurrence of potential harmful side effects as sedation and desaturation.
This mono-centric project involving American Society of Anesthesiologists (ASA) classification I-II patients undergoing elective neurosurgery (laminectomy) are recruited. Enrolled patients undergo numeric rating scale (NRS) and side effect questionnaire during the first 72h postoperatively.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Single center case-control study design|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia (PCIA) With Morphine for Postoperative Pain After Back Surgery. A Single Center Case-control Study.|
|Actual Study Start Date :||April 5, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||February 2020|
Sublingual sufentanil tablet system (SSTS) for postoperative pain relief after laminectomy or spinal fusion in the first 72 hour period. Orange-coloured tablets containing 15mcg sufentanil, the patient-controlled device is designed to deliver a single tablet with a minimum lockout interval of 20 minutes.
Device: Sublingual sufentanil tablet system
Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion.
Active Comparator: Control
Patient-controlled intravenous analgesia (PCIA) for postoperative pain relief after laminectomy or spinal fusion in the first 72 hour period. This classic patient-controlled IV-pump contains 1mg/ml morphine and 50mcg/ml dehydrobenzperidol. Pump characteristics include 1ml each asked bolus, lockout interval of 8 minutes.
Drug: Patient-controlled intravenous analgesia
Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion.
Other Name: PCIA
- Numeric Rating Scale (NRS) [ Time Frame: 72 hours postoperatively ]Pain assessment by NRS
- Evaluation of side effect [ Time Frame: 72 hours postoperatively ]Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness
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): NCT03036514
|University hospital Antwerp|
|Edegem, Antwerp, Belgium, 2650|
|Principal Investigator:||Davina Wildemeersch, MD||Universiteit Antwerpen|