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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Sublingual sufentanil tablet system
Patient-controlled intravenous analgesia
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Pain, Postoperative focused on measuring numeric rating scale, opioid side effects

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Case

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Numeric Rating Scale (NRS)
Pain assessment by NRS

Secondary Outcome Measures

Evaluation of side effect
Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness

Full Information

First Posted
January 26, 2017
Last Updated
March 6, 2020
Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen
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1. Study Identification

Unique Protocol Identification Number
NCT03036514
Brief Title
Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia After Back Surgery.
Official Title
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
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
numeric rating scale, opioid side effects

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Single center case-control study design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sublingual sufentanil tablet system
Other Intervention Name(s)
SSTS, Zalviso
Intervention Description
Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion.
Intervention Type
Drug
Intervention Name(s)
Patient-controlled intravenous analgesia
Other Intervention Name(s)
PCIA
Intervention Description
Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion.
Primary Outcome Measure Information:
Title
Numeric Rating Scale (NRS)
Description
Pain assessment by NRS
Time Frame
72 hours postoperatively
Secondary Outcome Measure Information:
Title
Evaluation of side effect
Description
Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness
Time Frame
72 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davina Wildemeersch, MD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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