Trial Outcomes & Findings for The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic Requirements in Spine Surgery Patients (NCT NCT04263909)
NCT ID: NCT04263909
Last Updated: 2025-03-30
Results Overview
pain scores as reported by the patient using NRS (numerical rating scale) 0 (no pain)-10 (worst possible pain)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
199 participants
Primary outcome timeframe
Up to 120 minutes after arrival to PACU
Results posted on
2025-03-30
Participant Flow
Participant milestones
| Measure |
Sufentanil SL Arm
Each patient received 30mcg of sufentanil SL prior to extubation in the operating room, and then as needed in the recovery room, guided by pain scores.
Sublingual Tablet: sufentanil SL 30mcg administered sublingually to patients undergoing spine surgery before extubation and during recovery
|
IV Remifentanil Historical Arm
Each patient received intraoperative remifentanil and hydromorphone for postoperative pain
|
IV Sufentanil Historical Arm
Each patient received intraoperative sufentanil and hydromorphone for postoperative pain
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
80
|
80
|
|
Overall Study
COMPLETED
|
30
|
80
|
80
|
|
Overall Study
NOT COMPLETED
|
9
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sufentanil SL Arm
Each patient received 30mcg of sufentanil SL prior to extubation in the operating room, and then as needed in the recovery room, guided by pain scores.
Sublingual Tablet: sufentanil SL 30mcg administered sublingually to patients undergoing spine surgery before extubation and during recovery
|
IV Remifentanil Historical Arm
Each patient received intraoperative remifentanil and hydromorphone for postoperative pain
|
IV Sufentanil Historical Arm
Each patient received intraoperative sufentanil and hydromorphone for postoperative pain
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
3
|
0
|
0
|
|
Overall Study
Protocol Violation
|
5
|
0
|
0
|
Baseline Characteristics
The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic Requirements in Spine Surgery Patients
Baseline characteristics by cohort
| Measure |
Sufentanil SL Arm
n=30 Participants
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.
Sublingual Tablet: sufentanil SL 30mcg administered sublingually to patients undergoing spine surgery before extubation and during recovery
|
IV Remifentanil Historical Arm
n=80 Participants
Each patient received intraoperative remifentanil and hydromorphone for postoperative pain
|
IV Sufentanil Historical Arm
n=80 Participants
Each patient received intraoperative sufentanil and hydromorphone for postoperative pain
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 14.2 • n=99 Participants
|
57.0 years
STANDARD_DEVIATION 11.3 • n=107 Participants
|
58.8 years
STANDARD_DEVIATION 12.4 • n=206 Participants
|
58.0 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
107 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
83 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
179 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
171 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
BMI
|
29.9 kg/m^2
STANDARD_DEVIATION 6.9 • n=99 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 5.1 • n=107 Participants
|
29.3 kg/m^2
STANDARD_DEVIATION 5.9 • n=206 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 5.7 • n=7 Participants
|
|
ASA Class
Class 1 (Normal healthy patient, no systemic disease)
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
ASA Class
Class 2 (mild systemic disease with no functional limitations
|
7 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
75 Participants
n=7 Participants
|
|
ASA Class
Class 3 (severe systemic disease that may limit activity or function but is not a threat to life)
|
22 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
112 Participants
n=7 Participants
|
|
Surgical Invasiveness Tier
tier 1: microdiscectomy
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Surgical Invasiveness Tier
tier 2: lumbar laminectomy, anterior cervical procedures, or minimally invasive spinal fusions
|
18 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
|
Surgical Invasiveness Tier
tier 3: standard/complex lumbar fusion, emergency surgery following trauma posterior cervical fusion
|
8 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
78 Participants
n=7 Participants
|
|
Surgical Invasiveness Tier
tier 4: surgeries to remove tumor, infection/deformity, or combined anterior & posterior cervical .
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
History of Anxiety
|
9 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Anxiolytic Use
|
2 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
History of Depression
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Antidepressant Use
|
5 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
|
Surgery duration (minutes)
|
182.5 minutes
n=99 Participants
|
224.0 minutes
n=107 Participants
|
249.0 minutes
n=206 Participants
|
229.0 minutes
n=7 Participants
|
|
Intraoperative IV acetaminophen
|
20 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
91 Participants
n=7 Participants
|
|
Average PACU pain score
|
3.2 units on a scale
STANDARD_DEVIATION 2.4 • n=99 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 2.2 • n=107 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 2.4 • n=206 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutes after arrival to PACUpain scores as reported by the patient using NRS (numerical rating scale) 0 (no pain)-10 (worst possible pain)
Outcome measures
| Measure |
Sufentanil SL Arm
n=30 Participants
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.
Sublingual Tablet: sufentanil SL 30mcg administered sublingually to patients undergoing spine surgery before extubation and during recovery
|
IV Remifentanil Historical Arm
n=80 Participants
Each patient received intraoperative remifentanil and hydromorphone for postoperative pain
|
IV Sufentanil Historical Arm
n=80 Participants
Each patient received intraoperative sufentanil and hydromorphone for postoperative pain
|
|---|---|---|---|
|
Average Postoperative Pain Score - PACU/ Post-anesthesia Care Unit
|
3.22 Pain score NSR
Standard Deviation 2.42
|
5.66 Pain score NSR
Standard Deviation 2.19
|
5.05 Pain score NSR
Standard Deviation 2.38
|
SECONDARY outcome
Timeframe: up to 120 min after arrival to the post anesthesia care unit (PACU)total amount of opioids (in morphine milligram equivalents) used
Outcome measures
| Measure |
Sufentanil SL Arm
n=30 Participants
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.
Sublingual Tablet: sufentanil SL 30mcg administered sublingually to patients undergoing spine surgery before extubation and during recovery
|
IV Remifentanil Historical Arm
n=80 Participants
Each patient received intraoperative remifentanil and hydromorphone for postoperative pain
|
IV Sufentanil Historical Arm
n=80 Participants
Each patient received intraoperative sufentanil and hydromorphone for postoperative pain
|
|---|---|---|---|
|
Opioid Consumption - PACU
|
6.13 morphine milligram equivalents
Standard Deviation 10.79
|
29.02 morphine milligram equivalents
Standard Deviation 21.45
|
23.06 morphine milligram equivalents
Standard Deviation 21.61
|
SECONDARY outcome
Timeframe: up to 48 hours, from arrival to inpatient floor until discharge hometotal amount of opioids (in morphine milligram equivalents) used
Outcome measures
| Measure |
Sufentanil SL Arm
n=30 Participants
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.
Sublingual Tablet: sufentanil SL 30mcg administered sublingually to patients undergoing spine surgery before extubation and during recovery
|
IV Remifentanil Historical Arm
n=80 Participants
Each patient received intraoperative remifentanil and hydromorphone for postoperative pain
|
IV Sufentanil Historical Arm
n=80 Participants
Each patient received intraoperative sufentanil and hydromorphone for postoperative pain
|
|---|---|---|---|
|
Opioid Consumption - Inpatient Floor
|
41.59 morphine milligram equivalents
Standard Deviation 36.43
|
74.51 morphine milligram equivalents
Standard Deviation 44.17
|
74.99 morphine milligram equivalents
Standard Deviation 45.71
|
SECONDARY outcome
Timeframe: up to 48 hours, from arrival to inpatient floor until discharge homepain scores as reported by the patient using NRS (numerical rating scale) 0 (no pain)-10 (worst possible pain)
Outcome measures
| Measure |
Sufentanil SL Arm
n=30 Participants
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.
Sublingual Tablet: sufentanil SL 30mcg administered sublingually to patients undergoing spine surgery before extubation and during recovery
|
IV Remifentanil Historical Arm
n=80 Participants
Each patient received intraoperative remifentanil and hydromorphone for postoperative pain
|
IV Sufentanil Historical Arm
n=80 Participants
Each patient received intraoperative sufentanil and hydromorphone for postoperative pain
|
|---|---|---|---|
|
Postoperative Pain Scores - Inpatient Floor
|
3.96 Pain score NSR
Standard Deviation 1.61
|
4.84 Pain score NSR
Standard Deviation 1.55
|
4.54 Pain score NSR
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: up to 24 hoursthe amount of time (in minutes) the patient stayed in the PACU until the patient was signed out as ready to be transferred to inpatient floor
Outcome measures
| Measure |
Sufentanil SL Arm
n=30 Participants
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.
Sublingual Tablet: sufentanil SL 30mcg administered sublingually to patients undergoing spine surgery before extubation and during recovery
|
IV Remifentanil Historical Arm
n=80 Participants
Each patient received intraoperative remifentanil and hydromorphone for postoperative pain
|
IV Sufentanil Historical Arm
n=80 Participants
Each patient received intraoperative sufentanil and hydromorphone for postoperative pain
|
|---|---|---|---|
|
Length of Stay in the PACU
|
129.23 minutes
Standard Deviation 77.15
|
127.53 minutes
Standard Deviation 54.83
|
118.50 minutes
Standard Deviation 52.59
|
SECONDARY outcome
Timeframe: up to 30 daysthe amount of time (in days) the patient stayed on the inpatient floor until the patient was discharged to home
Outcome measures
| Measure |
Sufentanil SL Arm
n=30 Participants
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.
Sublingual Tablet: sufentanil SL 30mcg administered sublingually to patients undergoing spine surgery before extubation and during recovery
|
IV Remifentanil Historical Arm
n=80 Participants
Each patient received intraoperative remifentanil and hydromorphone for postoperative pain
|
IV Sufentanil Historical Arm
n=80 Participants
Each patient received intraoperative sufentanil and hydromorphone for postoperative pain
|
|---|---|---|---|
|
Length of Stay on the Inpatient Floor
|
1.11 days
Standard Deviation 0.74
|
2.09 days
Standard Deviation 1.78
|
2.19 days
Standard Deviation 1.67
|
Adverse Events
Sufentanil SL Arm
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
IV Remifentanil Historical Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IV Sufentanil Historical Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sufentanil SL Arm
n=39 participants at risk
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.
Sublingual Tablet: sufentanil SL 30mcg administered sublingually to patients undergoing spine surgery before extubation and during recovery
|
IV Remifentanil Historical Arm
n=80 participants at risk
Each patient received intraoperative remifentanil and hydromorphone for postoperative pain
|
IV Sufentanil Historical Arm
n=80 participants at risk
Each patient received intraoperative sufentanil and hydromorphone for postoperative pain
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Other
|
7.7%
3/39 • Number of events 3 • Adverse events were monitored during the first two hours of the patient's post operative period of recovery.
Nausea or vomiting within the first two hours of taking SST
|
0.00%
0/80 • Adverse events were monitored during the first two hours of the patient's post operative period of recovery.
Nausea or vomiting within the first two hours of taking SST
|
0.00%
0/80 • Adverse events were monitored during the first two hours of the patient's post operative period of recovery.
Nausea or vomiting within the first two hours of taking SST
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place