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

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Patient-controlled intravenous analgesia; Device: Sublingual sufentanil tablet system

• Registration Number: NCT03036514
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-30
• Study Start: 2017-04-05
• Primary Completion: 2019-08-01
• Study Completion: 2019-09-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control	Patient-controlled intravenous analgesia	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.
Case	Sublingual sufentanil tablet system	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.

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS)	72 hours postoperatively	Pain assessment by NRS

Secondary Outcome Measures

Name	Time	Method
Evaluation of side effect	72 hours postoperatively	Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness

Trial Locations

Locations (1)

University hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium