Phase 2
Completed N=124
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
Postoperative Pain · hernia · Surgery
Source: ClinicalTrials.gov NCT00974350 ↗
Enrolled (actual)
124
Serious AEs
4.9%
Results posted
May 2021
Primary outcomePrimary: Pain Intensity on Movement — 3.4; 2.7; 3.9 score on a scale — p=0.0031
Summary
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. This study is testing SABER-Bupivacaine in people having surgery to repair a hernia.
The purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of SABER-Bupivacaine with SABER-Placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity on Movement |
3.4; 2.7; 3.9 | 0.0031 sig |
| PRIMARY Proportion (Percent) of Patients Using Supplemental Opioids |
31; 25; 23 | 0.0909 |
| SECONDARY Pain Intensity |
3.4; 2.8; 4.1 | — |
| SECONDARY Treatment Satisfaction |
2; 2; 0; 1; 0; 2 | — |
| SECONDARY Supplemental Opioid Use |
17.7; 12.5; 38.4 | — |
| SECONDARY Mean Function Activities (Modified Brief Pain Inventory) |
3.2; 2.7; 4.6; 3.0; 2.4; 3.0 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females, 18 to 65 years of age, scheduled for hernia repair surgery
- Patients must be in good health prior to study participation
- Patients must have blood pressure within normal range or with Stage 1 high blood pressure
- Male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed
- Patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial
- Ability to read, understand, communicate, and voluntarily sign the informed consent form prior to any trial specific procedures
Exclusion Criteria
- Patients with previous abdominal surgery scar tissue
- Patients with clinically significant abnormalities of any body system unrelated to the disease under study
- Connective tissue disorders
- Patients who are pregnant or lactating
- Current or regular use of analgesic medication for other indications
- Patients with current or regular use of antidepressants or monoamine oxidase inhibitors at screening
- Use of any drugs or medication that may interfere with the study and its results
- Patients with known hypersensitivity to the study drugs or their components
- Patients with known or suspected alcohol abuse or illicit drug use
- Participation in another clinical trial at the same time or within 30 days of this trial
- Patient is unwilling to comply with the study procedures
Data sourced from ClinicalTrials.gov (NCT00974350). 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.