Trial Outcomes & Findings for An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery (NCT NCT00993798)
NCT ID: NCT00993798
Last Updated: 2021-06-09
Results Overview
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0-3 days after surgery. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
COMPLETED
PHASE2
107 participants
0-3 days after surgery
2021-06-09
Participant Flow
Multicenter, randomized, double-blind, parallel-group, placebo- and active-controlled study in adult subjects undergoing elective arthroscopic subacromial decompression.
Participant milestones
| Measure |
SABER-Bupivacaine 5 mL
5 mL, single dose instilled subacromially
|
SABER-placebo 5 mL
5 mL, single dose instilled subacromially
|
Bupivacaine HCl 0.25% 20 mL
0.25% 20 mL, single dose instilled subacromially
|
SABER- Placebo 7.5 mL
7.5 mL, single dose instilled subacromially. This arm was never pursued.
|
SABER-Bupivacaine 7.5 mL
7.5 mL, single dose instilled subacromially. This arm was never pursued.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
25
|
29
|
0
|
0
|
|
Overall Study
COMPLETED
|
53
|
25
|
29
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery
Baseline characteristics by cohort
| Measure |
SABER-Bupivacaine
n=53 Participants
5 mL, single dose instilled subacromially
|
SABER-placebo
n=25 Participants
5 mL, single dose instilled subacromially
|
Bupivacaine HCl
n=29 Participants
0.25% 20 mL, single dose instilled subacromially
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.1 years
n=5 Participants
|
48.6 years
n=7 Participants
|
51.6 years
n=5 Participants
|
50.2 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0-3 days after surgeryMean pain intensity on movement AUC (time-normalized AUC) during the period 0-3 days after surgery. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Outcome measures
| Measure |
SABER-Bupivacaine
n=53 Participants
5 mL, single dose instilled subacromially
|
SABER-placebo
n=25 Participants
5 mL, single dose instilled subacromially
|
Bupivacaine HCl
n=29 Participants
0.25% 20 mL, single dose instilled subacromially
|
|---|---|---|---|
|
Pain Intensity (PI)
|
5.16 score on a scale (time-normalized AUC)
Standard Deviation 1.94
|
6.43 score on a scale (time-normalized AUC)
Standard Deviation 1.77
|
5.16 score on a scale (time-normalized AUC)
Standard Deviation 2.38
|
PRIMARY outcome
Timeframe: 0-3 days after surgeryCumulative IV morphine-equivalent dose of opioid rescue medication
Outcome measures
| Measure |
SABER-Bupivacaine
n=53 Participants
5 mL, single dose instilled subacromially
|
SABER-placebo
n=25 Participants
5 mL, single dose instilled subacromially
|
Bupivacaine HCl
n=29 Participants
0.25% 20 mL, single dose instilled subacromially
|
|---|---|---|---|
|
Supplemental Opioid Use
|
4.0 mg
Interval 0.0 to 15.0
|
12.0 mg
Interval 4.0 to 36.0
|
8.0 mg
Interval 0.0 to 16.0
|
SECONDARY outcome
Timeframe: 0-14 days after surgeryOutcome measures
| Measure |
SABER-Bupivacaine
n=53 Participants
5 mL, single dose instilled subacromially
|
SABER-placebo
n=25 Participants
5 mL, single dose instilled subacromially
|
Bupivacaine HCl
n=29 Participants
0.25% 20 mL, single dose instilled subacromially
|
|---|---|---|---|
|
Time to First Opioid Rescue Medication Usage
|
12.4 hours
Interval 1.2 to
The confidence interval is for a median estimated by a Kaplan-Meier curve. There were too few events overall to estimate an upper endpoint for this interval.
|
1.2 hours
Interval 0.7 to 1.5
|
1.4 hours
Interval 1.0 to 4.1
|
SECONDARY outcome
Timeframe: 0-7 days after surgeryOpioid-related side effects were recorded 0-7 days after surgery. The Opioid-Related Symptom Distress Scale (OR-SDS) is a composite score computed from a questionnaire containing frequent opioid-related symptoms (Fatigue, Drowsiness, Inability to concentrate, Nausea, Dizziness, Constipation, Itching, Difficulty with urination, Confusion, Retching/vomiting). For each symptom, patients assigned integer scores to assess severity (none=0 to very severe=4), bothersomeness (none=0 to very much=5), and frequency (none=0 to almost constantly=4); patients reported number of Retching/vomiting episodes (none=0, 1-2 episodes=1, 3-4 episodes=2, 5-6 episodes=3, \>6 episodes=4). On each day (Day 0-7), the score for each symptom was the mean of the three component scores, and the OR-SDS score was the overall mean of the 10 symptom scores, (values from 0 to 4; larger outcomes are worse). The mean of the daily OR-SDS score from Day 0 to 7 gave the overall OR-SDS Score.
Outcome measures
| Measure |
SABER-Bupivacaine
n=37 Participants
5 mL, single dose instilled subacromially
|
SABER-placebo
n=21 Participants
5 mL, single dose instilled subacromially
|
Bupivacaine HCl
n=23 Participants
0.25% 20 mL, single dose instilled subacromially
|
|---|---|---|---|
|
Opioid Related Side Effects
|
0.22 score on a scale
Standard Deviation 0.35
|
0.22 score on a scale
Standard Deviation 0.24
|
0.25 score on a scale
Standard Deviation 0.24
|
Adverse Events
SABER-Bupivacaine
SABER-placebo
Bupivacaine HCl
Serious adverse events
| Measure |
SABER-Bupivacaine
n=53 participants at risk
5 mL, single dose instilled subacromially
|
SABER-placebo
n=25 participants at risk
5 mL, single dose instilled subacromially
|
Bupivacaine HCl
n=29 participants at risk
0.25% 20 mL, single dose instilled subacromially
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/53
|
0.00%
0/25
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
1.9%
1/53
|
0.00%
0/25
|
0.00%
0/29
|
|
General disorders
Drug intolerance
|
0.00%
0/53
|
4.0%
1/25
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/53
|
0.00%
0/25
|
3.4%
1/29
|
|
Nervous system disorders
Tongue paralysis
|
0.00%
0/53
|
0.00%
0/25
|
3.4%
1/29
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/53
|
0.00%
0/25
|
3.4%
1/29
|
Other adverse events
| Measure |
SABER-Bupivacaine
n=53 participants at risk
5 mL, single dose instilled subacromially
|
SABER-placebo
n=25 participants at risk
5 mL, single dose instilled subacromially
|
Bupivacaine HCl
n=29 participants at risk
0.25% 20 mL, single dose instilled subacromially
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
5.7%
3/53
|
4.0%
1/25
|
3.4%
1/29
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53
|
4.0%
1/25
|
3.4%
1/29
|
|
Nervous system disorders
Hypoaesthesia
|
1.9%
1/53
|
0.00%
0/25
|
3.4%
1/29
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/53
|
12.0%
3/25
|
3.4%
1/29
|
|
Investigations
ALT increased
|
1.9%
1/53
|
8.0%
2/25
|
0.00%
0/29
|
|
Investigations
ECG T wave abnormal
|
3.8%
2/53
|
0.00%
0/25
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.8%
2/53
|
4.0%
1/25
|
6.9%
2/29
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/53
|
4.0%
1/25
|
3.4%
1/29
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.8%
2/53
|
0.00%
0/25
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
3.8%
2/53
|
0.00%
0/25
|
0.00%
0/29
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place