Phase 4
N=199
The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic Requirements in Spine Surgery Patients
Spine Fusion · Pain, Postoperative · Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT04263909 ↗Enrolled (actual)
199
Serious AEs
1.5%
Results posted
Mar 2025
Primary outcome: Primary: Average Postoperative Pain Score - PACU/ Post-anesthesia Care Unit — 3.22; 5.66; 5.05 Pain score NSR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sublingual Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Postoperative Pain Score - PACU/ Post-anesthesia Care Unit |
3.22; 5.66; 5.05 | — |
| SECONDARY Opioid Consumption - PACU |
6.13; 29.02; 23.06 | — |
| SECONDARY Opioid Consumption - Inpatient Floor |
41.59; 74.51; 74.99 | — |
| SECONDARY Postoperative Pain Scores - Inpatient Floor |
3.96; 4.84; 4.54 | — |
| SECONDARY Length of Stay in the PACU |
129.23; 127.53; 118.50 | — |
| SECONDARY Length of Stay on the Inpatient Floor |
1.11; 2.09; 2.19 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing spine surgery (> 1 levels)
- Opioid-naïve
- ≥18 years old
- American Society of Anesthesiologists class 1-4
- Planned inpatient stay
Exclusion Criteria
- Microdiscectomy or single level surgery
- Chronic opiate use
- Liver disease
- Allergy/hypersensitivity to sufentanil
- Patients with baseline dementia
- Plan outpatient surgery
Data sourced from ClinicalTrials.gov (NCT04263909). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.