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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
27
Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion.
Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion.
University hospital Antwerp
Edegem, Antwerp, Belgium
Numeric Rating Scale (NRS)
Pain assessment by NRS
Time frame: 72 hours postoperatively
Evaluation of side effect
Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness
Time frame: 72 hours postoperatively
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