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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 : Completed
First Posted : January 30, 2017
Last Update Posted : March 9, 2020
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Davina Wildemeersch, University Hospital, Antwerp

Tracking Information
First Submitted Date  ICMJE January 26, 2017
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date March 9, 2020
Actual Study Start Date  ICMJE April 5, 2017
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
Numeric Rating Scale (NRS) [ Time Frame: 72 hours postoperatively ]
Pain assessment by NRS
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
Evaluation of side effect [ Time Frame: 72 hours postoperatively ]
Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia After Back Surgery.
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Single center case-control study design
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • 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
  • Drug: Patient-controlled intravenous analgesia
    Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion.
    Other Name: PCIA
Study Arms  ICMJE
  • 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.
    Intervention: Device: Sublingual sufentanil tablet system
  • 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.
    Intervention: Drug: Patient-controlled intravenous analgesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2020)
27
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
25
Actual Study Completion Date  ICMJE September 1, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03036514
Other Study ID Numbers  ICMJE 16/45/479
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Davina Wildemeersch, University Hospital, Antwerp
Study Sponsor  ICMJE University Hospital, Antwerp
Collaborators  ICMJE Universiteit Antwerpen
Investigators  ICMJE
Principal Investigator: Davina Wildemeersch, MD Universiteit Antwerpen
PRS Account University Hospital, Antwerp
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP