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

NCT03036514 | Completed

• 1 other identifier: 16/45/479
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain, Postoperative

Keywords

numeric rating scale; opioid side effects

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS)

  Pain assessment by NRS

  72 hours postoperatively

Secondary Outcomes (1)

• Evaluation of side effect

  72 hours postoperatively

Study Arms (2)

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.

Device: Sublingual sufentanil tablet system

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.

Drug: Patient-controlled intravenous analgesia

Interventions

Sublingual sufentanil tablet system DEVICE

Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion.

Also known as: SSTS, Zalviso

Case

Patient-controlled intravenous analgesia DRUG

Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion.

Also known as: PCIA

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled elective laminectomy or spinal fusion
• American Society Anesthesiology Classification system (ASA) I-III

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Davina Wildemeersch, MD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Single center case-control study design

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 30, 2017
• Study Start: April 5, 2017
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)