A Phase 2 interventional study of SABER-Bupivacaine Treatment 1a and Placebo SABER-Bupivacaine Treatment 1b in Postoperative Pain, sponsored by Durect. Completed at 14 sites in 6 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-01.
Sponsored by Durect · Phase 2, Interventional, and Treatment
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on the efficacy and safety of the product.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 115 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Durect is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
double-blind
Drug: SABER-Bupivacaine Treatment 1a
double-blind
Drug: Placebo SABER-Bupivacaine Treatment 1b
double-blind
Drug: Bupivacaine HCl Treatment 1c
double-blind
Drug: SABER-Bupivacaine Treatment 2a
double-blind
Drug: Placebo SABER-Bupivacaine Treatment 2b
double-blind
Drug: Bupivacaine HCl Treatment 2c
5.0 ml
5.0 ml
Also known as: POSIMIR® bupivacaine solution
40 ml
7.5 ml
7.5 ml
40 ml
Pain Intensity (PI)
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.
Time frame: 1 to 72 hours post-surgery
Supplemental Opioid Use
Cumulative IV morphine-equivalent dose of opioid rescue medication
Time frame: 0-3 days after surgery
Time to First Opioid Rescue Medication Usage
Time frame: 0-14 days after surgery
Opioid Related Side Effects
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.
Time frame: 0-7 days after surgery
| Milestone | SABER-Bupivacaine | SABER-placebo | Bupivacaine HCl |
|---|---|---|---|
| Started | 61 | 27 | 27 |
| Completed | 60 | 26 | 27 |
| Not completed | 1 | 1 | 0 |
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.
| score on a scale | SABER-Bupivacaine | SABER-placebo | Bupivacaine HCl |
|---|---|---|---|
| Pain Intensity (PI) | 4.15 ± 1.74 | 4.46 ± 1.48 | 4.27 ± 1.69 |
Cumulative IV morphine-equivalent dose of opioid rescue medication
| mg | SABER-Bupivacaine | SABER-placebo | Bupivacaine HCl |
|---|---|---|---|
| Supplemental Opioid Use | 22.8 ± 24.3 | 26.3 ± 25.7 | 23.9 ± 25.9 |
| hours | SABER-Bupivacaine | SABER-placebo | Bupivacaine HCl |
|---|---|---|---|
| Time to First Opioid Rescue Medication Usage | 7.71 ± 45.79 | 1.53 ± 1.56 | 87.77 ± 1.11 |
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.
| score on a scale | SABER-Bupivacaine | SABER-placebo | Bupivacaine HCl |
|---|---|---|---|
| Opioid Related Side Effects | 0.28 ± 0.28 | 0.34 ± 0.31 | 0.27 ± 0.24 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SABER-Bupivacaine | 0/60 (0%) | 7/60 (11.7%) | 48/60 (80%) |
| SABER-placebo | 0/27 (0%) | 0/27 (0%) | 17/27 (63%) |
| Bupivacaine HCl | 0/27 (0%) | 0/27 (0%) | 19/27 (70.4%) |
| Event | SABER-Bupivacaine | SABER-placebo | Bupivacaine HCl |
|---|---|---|---|
| ECG abnormalInvestigations | 2/60 | 0/27 | 0/27 |
| Haematoma infectionInfections and infestations | 2/60 | 0/27 | 0/27 |
| ECG QT prolongedInvestigations | 1/60 | 0/27 | 0/27 |
| BronchospasmRespiratory, thoracic and mediastinal disorders | 1/60 | 0/27 | 0/27 |
| Laryngeal oedemaRespiratory, thoracic and mediastinal disorders | 1/60 | 0/27 | 0/27 |
| Renal neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/60 | 0/27 | 0/27 |
| Event | SABER-Bupivacaine | SABER-placebo | Bupivacaine HCl |
|---|---|---|---|
| Post procedural contusionInjury, poisoning and procedural complications | 36/60 | 9/27 | 0/27 |
| VomitingGastrointestinal disorders | 9/60 | 8/27 | 4/27 |
| PyrexiaGeneral disorders | 7/60 | 3/27 | 7/27 |
| AnaemiaBlood and lymphatic system disorders | 10/60 | 4/27 | 3/27 |
| DizzinessNervous system disorders | 9/60 | 3/27 | 4/27 |
| CRP increasedInvestigations | 7/60 | 0/27 | 1/27 |
| SomnolenceNervous system disorders | 5/60 | 0/27 | 2/27 |
| HypertensionVascular disorders | 4/60 | 1/27 | 2/27 |
| Blood potassium decreasedInvestigations | 4/60 | 1/27 | 0/27 |
| Incision site haematomaInjury, poisoning and procedural complications | 3/60 | 0/27 | 0/27 |
| Age, Continuous(years) | SABER-Bupivacaine | SABER-placebo | Bupivacaine HCl | Total |
|---|---|---|---|---|
| Mean | 46.7 (29 to 66) | 44.3 (37 to 53) | 45.1 (35 to 55) | 45.8 (29 to 66) |
| Sex: Female, Male(Participants) | SABER-Bupivacaine | SABER-placebo | Bupivacaine HCl | Total |
|---|---|---|---|---|
| Female | 61 | 27 | 27 | 115 |
| Male | 0 | 0 | 0 | 0 |
| BMI(kg/m^2) | SABER-Bupivacaine | SABER-placebo | Bupivacaine HCl | Total |
|---|---|---|---|---|
| Mean | 26.1 (19.0 to 33.2) | 26.2 (19.4 to 34.1) | 27.0 (18.3 to 35.0) | 26.4 (18.3 to 35.0) |
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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