The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic Requirements in Spine Surgery Patients

NCT04263909 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2020P000726
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators plan to examine the perioperative use of sufentanil sublingual (SL) in the analgesic regimen for spine surgery, one of the most common surgeries performed in the US. Patients undergoing spinal fusion surgery often experience severe pain during the first three postoperative days. Currently, no data are available for this patient population which routinely experiences moderate to severe acute pain. The investigators will analyze whether sufentanil SL is associated with lower opioid consumption in the post anesthesia care unit and pain scores.

Conditions

Spine Fusion; Pain, Postoperative; Opioid Use

Keywords

sufentanil SL; Postoperative Pain; Spine Surgery

Outcome Measures

Primary Outcomes (1)

• Average Postoperative Pain Score - PACU/ Post-anesthesia Care Unit

  pain scores as reported by the patient using NRS (numerical rating scale) 0 (no pain)-10 (worst possible pain)

  Up to 120 minutes after arrival to PACU

Secondary Outcomes (5)

• Opioid Consumption - PACU

  up to 120 min after arrival to the post anesthesia care unit (PACU)

• Opioid Consumption - Inpatient Floor

  up to 48 hours, from arrival to inpatient floor until discharge home

• Postoperative Pain Scores - Inpatient Floor

  up to 48 hours, from arrival to inpatient floor until discharge home

• Length of Stay in the PACU

  up to 24 hours

• Length of Stay on the Inpatient Floor

  up to 30 days

Study Arms (1)

sufentanil SL arm

EXPERIMENTAL

Each patient will receive 30mcg of sufentanil SL prior to extubation in the operating room, and then as needed in the recovery room, guided by pain scores.

Drug: Sublingual Tablet

Interventions

Sublingual Tablet DRUG

sufentanil SL 30mcg administered sublingually to patients undergoing spine surgery before extubation and during recovery

Also known as: sufentanil SL

sufentanil SL arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing spine surgery (\> 1 levels)
• Opioid-naïve
• ≥18 years old
• American Society of Anesthesiologists class 1-4
• Planned inpatient stay

You may not qualify if:

• Microdiscectomy or single level surgery
• Chronic opiate use
• Liver disease
• Allergy/hypersensitivity to sufentanil
• Patients with baseline dementia
• Plan outpatient surgery

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

• Bernstein MH, Beaudoin FL, Magill M. Response to FDA Commissioner's statement on Dsuvia approval. Addiction. 2019 Apr;114(4):757-758. doi: 10.1111/add.14539. Epub 2019 Jan 20. No abstract available.

  PMID: 30589478 BACKGROUND

• Sufentanil. 2025 Dec 15. Drugs and Lactation Database (LactMed(R)) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. Available from http://www.ncbi.nlm.nih.gov/books/NBK501254/

  PMID: 30000313 BACKGROUND

• van de Donk T, Ward S, Langford R, Dahan A. Pharmacokinetics and pharmacodynamics of sublingual sufentanil for postoperative pain management. Anaesthesia. 2018 Feb;73(2):231-237. doi: 10.1111/anae.14132. Epub 2017 Dec 8.

  PMID: 29219169 BACKGROUND

• Babazade R, Turan A. Sufentanil sublingual tablet system for the management of postoperative pain. Expert Opin Pharmacother. 2016 Dec;17(17):2351-2357. doi: 10.1080/14656566.2016.1254190.

  PMID: 27796147 BACKGROUND

• Deeks ED. Sufentanil 30 microg Sublingual Tablet: A Review in Acute Pain. Clin Drug Investig. 2019 Apr;39(4):411-418. doi: 10.1007/s40261-019-00772-x.

  PMID: 30887417 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Administration, Sublingual; Sufentanil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Administration, Oral; Drug Administration Routes; Drug Therapy; Therapeutics; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Linda S. Aglio, MD MS
• Organization: BWH Anesthesia

laglio@bwh.harvard.edu

6177328480

Study Officials

• Richard D. Urman, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor,

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 11, 2020
• Study Start: December 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: December 30, 2023
• Last Updated: March 30, 2025
• Results First Posted: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)