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

NCT03036514 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-03-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

  • Universiteit Antwerpen

    collaborator OTHER

Principal Investigators

  • Davina Wildemeersch, MD · Universiteit Antwerpen

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-05
Primary Completion
2019-08-01
Completion
2019-09-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03036514 on ClinicalTrials.gov