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

NCT ID: NCT03036514

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-05
• Study Completion Date: 2019-09-01

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sublingual sufentanil tablet system

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Patient-controlled intravenous analgesia

Intervention Type: DRUG

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

Interventions

Sublingual sufentanil tablet system

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

Intervention Type: DEVICE

Patient-controlled intravenous analgesia

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

Intervention Type: DRUG

Other Intervention Names

SSTS; Zalviso; PCIA

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Davina Wildemeersch

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Davina Wildemeersch, MD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

University hospital Antwerp

Edegem, Antwerp, Belgium

Countries

Belgium

Other Identifiers

16/45/479

Identifier Type: -

Identifier Source: org_study_id