Phase 2
Completed N=115
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
Source: ClinicalTrials.gov NCT00993226 ↗Enrolled (actual)
115
Serious AEs
6.1%
Results posted
Jun 2021
Primary outcomePrimary: Pain Intensity (PI) — 4.15; 4.46; 4.27 score on a scale — p=0.467
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity (PI) |
4.15; 4.46; 4.27 | 0.467 |
| PRIMARY Supplemental Opioid Use |
22.8; 26.3; 23.9 | 0.331 |
| SECONDARY Time to First Opioid Rescue Medication Usage |
7.71; 1.53; 87.77 | — |
| SECONDARY Opioid Related Side Effects |
0.28; 0.34; 0.27 | — |
Eligibility Criteria
Inclusion Criteria
- A planned elective, abdominal hysterectomy
- Patients suitable for general anaesthesia
Exclusion Criteria
- Known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities
- Known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances. History of cured localised malignancies is allowed (i.e. basal or squamous cell skin carcinoma, breast carcinoma or cervical carcinoma)
- Abnormal ECG
- Prolonged QT syndrome
- Current or regular use of analgesic medication for other indication(s)
Data sourced from ClinicalTrials.gov (NCT00993226). 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. Informational only — not medical advice.