Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia After Back Surgery.

Study Overview
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Brief Summary
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In this study, numeric rating scale (NRS) and side effects are measured after usage of a sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient controlled analgesia (PCIA).

Detailed Description
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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.

Official Title
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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.

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Device: Sublingual sufentanil tablet system
* Drug: Patient-controlled intravenous analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled elective laminectomy or spinal fusion American Society Anesthesiology Classification system (ASA) I-III Exclusion Criteria: chronic opioid use (>3 months) pregnancy obstructive sleep apnea syndrome supplemental oxygen therapy at home postoperative use of non-steroidal anti-inflammatory or anti-neuropathic drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Single center case-control study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case<br>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<br>* Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion.<br>* Other names: Zalviso;|
| Active Comparator: Control<br>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<br>* Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion.<br>* Other names: PCIA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale (NRS) | Pain assessment by NRS | 72 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of side effect | Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness | 72 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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numeric rating scale, opioid side effects