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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03036514

Enrollment

Registered

2017-01-30

Start date

2017-04-05

Completion date

2019-09-01

Last updated

2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

numeric rating scale, opioid side effects

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.

Interventions

DEVICESublingual sufentanil tablet system

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

DRUGPatient-controlled intravenous analgesia

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Intervention model description

Single center case-control study design

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Numeric Rating Scale (NRS)	72 hours postoperatively	Pain assessment by NRS

Secondary

Measure	Time frame	Description
Evaluation of side effect	72 hours postoperatively	Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026