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

Overview

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).

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 1, 2019

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.

Interventions

  • Device: Sublingual sufentanil tablet system
    • Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion.
  • Drug: Patient-controlled intravenous analgesia
    • Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion.

Arms, Groups and Cohorts

  • Experimental: Case
    • 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.
  • Active Comparator: Control
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Numeric Rating Scale (NRS)
    • Time Frame: 72 hours postoperatively
    • Pain assessment by NRS

Secondary Measures

  • Evaluation of side effect
    • Time Frame: 72 hours postoperatively
    • Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Antwerp
  • Collaborator
    • Universiteit Antwerpen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Davina Wildemeersch, MD – University Hospital, Antwerp
  • Overall Official(s)
    • Davina Wildemeersch, MD, Principal Investigator, Universiteit Antwerpen

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