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

Pain, Postoperative Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036514
• Other study ID #: 16/45/479
• Status: Completed
• Phase: N/A
• Start date: April 5, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Device:
• Sublingual sufentanil tablet system
Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion.

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

Locations

Country	Name	City	State
Belgium	University hospital Antwerp	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale (NRS)	Pain assessment by NRS	72 hours postoperatively
Secondary	Evaluation of side effect	Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness	72 hours postoperatively