Trial Outcomes & Findings for An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy (NCT NCT00993226)
NCT ID: NCT00993226
Last Updated: 2021-06-01
Results Overview
Pain intensity (PI) on movement AUC over the period 1 to 72 hours post-surgery. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). 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
115 participants
1 to 72 hours post-surgery
2021-06-01
Participant Flow
Participant milestones
| Measure |
SABER-Bupivacaine
5 mL, single dose instilled into surgical incision
|
SABER-placebo
5 mL, single dose instilled into surgical incision
|
Bupivacaine HCl
0.25% 40 mL, single dose infiltrated peri-incisionally
|
|---|---|---|---|
|
Overall Study
STARTED
|
61
|
27
|
27
|
|
Overall Study
COMPLETED
|
60
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
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 Undergoing Hysterectomy
Baseline characteristics by cohort
| Measure |
SABER-Bupivacaine
n=61 Participants
5 mL, single dose instilled into surgical incision
|
SABER-placebo
n=27 Participants
5 mL, single dose instilled into surgical incision
|
Bupivacaine HCl
n=27 Participants
0.25% 40 mL, single dose infiltrated peri-incisionally
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.7 years
n=5 Participants
|
44.3 years
n=7 Participants
|
45.1 years
n=5 Participants
|
45.8 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
BMI
|
26.1 kg/m^2
n=5 Participants
|
26.2 kg/m^2
n=7 Participants
|
27.0 kg/m^2
n=5 Participants
|
26.4 kg/m^2
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 to 72 hours post-surgeryPopulation: ITT population (patients with data available)
Pain intensity (PI) on movement AUC over the period 1 to 72 hours post-surgery. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). 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=60 Participants
5 mL, single dose instilled into surgical incision
|
SABER-placebo
n=27 Participants
5 mL, single dose instilled into surgical incision
|
Bupivacaine HCl
n=27 Participants
0.25% 40 mL, single dose infiltrated peri-incisionally
|
|---|---|---|---|
|
Pain Intensity (PI)
|
4.15 score on a scale
Standard Deviation 1.74
|
4.46 score on a scale
Standard Deviation 1.48
|
4.27 score on a scale
Standard Deviation 1.69
|
PRIMARY outcome
Timeframe: 0-3 days after surgeryPopulation: ITT population (patients with data available)
Cumulative IV morphine-equivalent dose of opioid rescue medication
Outcome measures
| Measure |
SABER-Bupivacaine
n=61 Participants
5 mL, single dose instilled into surgical incision
|
SABER-placebo
n=27 Participants
5 mL, single dose instilled into surgical incision
|
Bupivacaine HCl
n=27 Participants
0.25% 40 mL, single dose infiltrated peri-incisionally
|
|---|---|---|---|
|
Supplemental Opioid Use
|
22.8 mg
Standard Deviation 24.3
|
26.3 mg
Standard Deviation 25.7
|
23.9 mg
Standard Deviation 25.9
|
SECONDARY outcome
Timeframe: 0-14 days after surgeryPopulation: ITT population (patients with data available)
Outcome measures
| Measure |
SABER-Bupivacaine
n=61 Participants
5 mL, single dose instilled into surgical incision
|
SABER-placebo
n=27 Participants
5 mL, single dose instilled into surgical incision
|
Bupivacaine HCl
n=27 Participants
0.25% 40 mL, single dose infiltrated peri-incisionally
|
|---|---|---|---|
|
Time to First Opioid Rescue Medication Usage
|
7.71 hours
Standard Deviation 45.79
|
1.53 hours
Standard Deviation 1.56
|
87.77 hours
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: 0-7 days after surgeryPopulation: ITT population (patients with data available)
Opioid-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=53 Participants
5 mL, single dose instilled into surgical incision
|
SABER-placebo
n=25 Participants
5 mL, single dose instilled into surgical incision
|
Bupivacaine HCl
n=23 Participants
0.25% 40 mL, single dose infiltrated peri-incisionally
|
|---|---|---|---|
|
Opioid Related Side Effects
|
0.28 score on a scale
Standard Deviation 0.28
|
0.34 score on a scale
Standard Deviation 0.31
|
0.27 score on a scale
Standard Deviation 0.24
|
Adverse Events
SABER-Bupivacaine
SABER-placebo
Bupivacaine HCl
Serious adverse events
| Measure |
SABER-Bupivacaine
n=60 participants at risk
5 mL, single dose instilled into surgical incision
|
SABER-placebo
n=27 participants at risk
5 mL, single dose instilled into surgical incision
|
Bupivacaine HCl
n=27 participants at risk
0.25% 40 mL, single dose infiltrated peri-incisionally
|
|---|---|---|---|
|
Investigations
ECG abnormal
|
3.3%
2/60
|
0.00%
0/27
|
0.00%
0/27
|
|
Investigations
ECG QT prolonged
|
1.7%
1/60
|
0.00%
0/27
|
0.00%
0/27
|
|
Infections and infestations
Haematoma infection
|
3.3%
2/60
|
0.00%
0/27
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.7%
1/60
|
0.00%
0/27
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
1.7%
1/60
|
0.00%
0/27
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
1.7%
1/60
|
0.00%
0/27
|
0.00%
0/27
|
Other adverse events
| Measure |
SABER-Bupivacaine
n=60 participants at risk
5 mL, single dose instilled into surgical incision
|
SABER-placebo
n=27 participants at risk
5 mL, single dose instilled into surgical incision
|
Bupivacaine HCl
n=27 participants at risk
0.25% 40 mL, single dose infiltrated peri-incisionally
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
60.0%
36/60
|
33.3%
9/27
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
10/60
|
14.8%
4/27
|
11.1%
3/27
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
9/60
|
29.6%
8/27
|
14.8%
4/27
|
|
Nervous system disorders
Dizziness
|
15.0%
9/60
|
11.1%
3/27
|
14.8%
4/27
|
|
General disorders
Pyrexia
|
11.7%
7/60
|
11.1%
3/27
|
25.9%
7/27
|
|
Investigations
CRP increased
|
11.7%
7/60
|
0.00%
0/27
|
3.7%
1/27
|
|
Nervous system disorders
Somnolence
|
8.3%
5/60
|
0.00%
0/27
|
7.4%
2/27
|
|
Investigations
Blood potassium decreased
|
6.7%
4/60
|
3.7%
1/27
|
0.00%
0/27
|
|
Vascular disorders
Hypertension
|
6.7%
4/60
|
3.7%
1/27
|
7.4%
2/27
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
5.0%
3/60
|
0.00%
0/27
|
0.00%
0/27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place