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

Antwerp University Hospital (UZA)

Status: Completed

Conditions: Pain, Postoperative

Treatments: Device: Sublingual sufentanil tablet system; Drug: Patient-controlled intravenous analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03036514

16/45/479

Details and patient eligibility

About

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).

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Case

Experimental group

Description:

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.

Treatment:

Device: Sublingual sufentanil tablet system

Control

Active Comparator group

Description:

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.

Treatment:

Drug: Patient-controlled intravenous analgesia