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| Name | Class |
|---|---|
| Universiteit Antwerpen | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | Experimental | 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. |
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| Control | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual sufentanil tablet system | Device | Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) | Pain assessment by NRS | 72 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of side effect | Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness | 72 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Davina Wildemeersch, MD | Universiteit Antwerpen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Antwerp | Edegem | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Single center case-control study design
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| Patient-controlled intravenous analgesia | Drug | Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion. |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |