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Completed

NCT Number: NCT03036514

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

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).

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sublingual sufentanil tablet system

Device

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

Other names: SSTS, Zalviso

Patient-controlled intravenous analgesia

Drug

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

Other names: PCIA

Primary outcomes

  1. Numeric Rating Scale (NRS)

    Time frame: 72 hours postoperatively

    Pain assessment by NRS

Secondary outcomes

  1. Evaluation of side effect

    Time frame: 72 hours postoperatively

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

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Universiteit Antwerpen

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2017
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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