Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia After Back Surgery.
Pain, Postoperative
About this trial
This is an interventional device feasibility trial for Pain, Postoperative focused on measuring numeric rating scale, opioid side effects
Eligibility Criteria
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
Sites / Locations
- University hospital Antwerp
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Case
Control
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.
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.