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

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ClinicalTrials.gov Identifier: NCT03036514
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Davina Wildemeersch, 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).

Condition or disease Intervention/treatment Phase
Pain, Postoperative Device: Sublingual sufentanil tablet system Drug: Patient-controlled intravenous analgesia Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Single center case-control study design
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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.
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: Sublingual sufentanil tablet system
Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion.
Other Names:
  • SSTS
  • Zalviso

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.
Drug: Patient-controlled intravenous analgesia
Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion.
Other Name: PCIA




Primary Outcome Measures :
  1. Numeric Rating Scale (NRS) [ Time Frame: 72 hours postoperatively ]
    Pain assessment by NRS


Secondary Outcome Measures :
  1. Evaluation of side effect [ Time Frame: 72 hours postoperatively ]
    Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036514


Locations
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Belgium
University hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Investigators
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Principal Investigator: Davina Wildemeersch, MD Universiteit Antwerpen

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Responsible Party: Davina Wildemeersch, MD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03036514     History of Changes
Other Study ID Numbers: 16/45/479
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Davina Wildemeersch, University Hospital, Antwerp:
numeric rating scale
opioid side effects

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics