Trial · NCT00974350
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
NCT00974350, Phase 2, Completed, Durect; results first posted 2021-05-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair. Trials, record NCT00974350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00974350
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
- NCT number
- NCT00974350
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- Durect
- Conditions
- Postoperative Pain, Hernia, Surgery
- Interventions
- SABER-Bupivacaine, SABER-Bupivacaine, SABER-Placebo
- First posted
- 2009-09-10
- Last updated
- 2021-05-27
- Results first posted
- 2021-05-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Intensity on Movement | 1 to 72 hours post-dose | Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with 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. |
| Primary | Proportion (Percent) of Patients Using Supplemental Opioids | 0 to 14 days post-dose | |
| Secondary | Pain Intensity | 1 to 48 hours post-dose | Pain intensity AUC over the time period of 1 to 48 hours. Data on pain intensity were collected using a 0 to 10 NRS with 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. |
| Secondary | Treatment Satisfaction | 1 to 5 days post-dose | Modified Brief Pain Inventory -An overall assessment of treatment satisfaction was made using 6 point verbal rating scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied). |
| Secondary | Supplemental Opioid Use | 0 to 14 days post-dose | |
| Secondary | Mean Function Activities (Modified Brief Pain Inventory) | 1 to 5 days post-dose | In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Intensity on Movement | 1 to 72 hours post-dose | ITT population (patients with data available) | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Proportion (Percent) of Patients Using Supplemental Opioids | 0 to 14 days post-dose | ITT population (patients with data available) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pain Intensity | 1 to 48 hours post-dose | ITT population (patients with data available) | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Treatment Satisfaction | 1 to 5 days post-dose | ITT population (patients with data available) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Supplemental Opioid Use | 0 to 14 days post-dose | ITT population (patients with data available) | Total morphine equivalent dose (mg) | MEAN |
| SECONDARY | Mean Function Activities (Modified Brief Pain Inventory) | 1 to 5 days post-dose | ITT population (patients with data available) | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group222
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Intensity on Movement | Group 1: SABER-Bupivacaine | 3.4 | Standard Error 0.26 | score on a scale | |
| Pain Intensity on Movement | Group 2: SABER-Bupivacaine | 2.7 | Standard Error 0.25 | score on a scale | |
| Pain Intensity on Movement | Group 3: SABER-Placebo | 3.9 | Standard Error 0.29 | score on a scale | |
| Proportion (Percent) of Patients Using Supplemental Opioids | Group 1: SABER-Bupivacaine | 31 | Participants | ||
| Proportion (Percent) of Patients Using Supplemental Opioids | Group 2: SABER-Bupivacaine | 25 | Participants | ||
| Proportion (Percent) of Patients Using Supplemental Opioids | Group 3: SABER-Placebo | 23 | Participants | ||
| Pain Intensity | Group 1: SABER-Bupivacaine | 3.4 | Standard Error 0.26 | score on a scale | |
| Pain Intensity | Group 2: SABER-Bupivacaine | 2.8 | Standard Error 0.26 | score on a scale | |
| Pain Intensity | Group 3: SABER-Placebo | 4.1 | Standard Error 0.30 | score on a scale | |
| Treatment Satisfaction | Group 1: SABER-Bupivacaine | Day 1 / Very Dissatisfied | 2 | Participants |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: SABER-Bupivacaine | 45 | |
| Overall Study | STARTED | Group 2: SABER-Bupivacaine | 47 | |
| Overall Study | STARTED | Group 3: SABER-Placebo | 32 | |
| Overall Study | COMPLETED | Group 1: SABER-Bupivacaine | 42 | |
| Overall Study | COMPLETED | Group 2: SABER-Bupivacaine | 47 | |
| Overall Study | COMPLETED | Group 3: SABER-Placebo | 31 | |
| Overall Study | NOT COMPLETED | Group 1: SABER-Bupivacaine | 3 | |
| Overall Study | NOT COMPLETED | Group 2: SABER-Bupivacaine | 0 | |
| Overall Study | NOT COMPLETED | Group 3: SABER-Placebo | 1 |
Source ClinicalTrials.gov
Adverse events63
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bradycardia | Cardiac disorders | Group 1: SABER-Bupivacaine | 9 | 44 | |
| other | Bradycardia | Cardiac disorders | Group 2: SABER-Bupivacaine | 12 | 47 | |
| other | Bradycardia | Cardiac disorders | Group 3: SABER-Placebo | 7 | 32 | |
| other | Tinnitus | Ear and labyrinth disorders | Group 1: SABER-Bupivacaine | 3 | 44 | |
| other | Tinnitus | Ear and labyrinth disorders | Group 2: SABER-Bupivacaine | 6 | 47 | |
| other | Tinnitus | Ear and labyrinth disorders | Group 3: SABER-Placebo | 5 | 32 | |
| other | Constipation | Gastrointestinal disorders | Group 1: SABER-Bupivacaine | 17 | 44 | |
| other | Constipation | Gastrointestinal disorders | Group 2: SABER-Bupivacaine | 13 | 47 | |
| other | Constipation | Gastrointestinal disorders | Group 3: SABER-Placebo | 18 | 32 | |
| other | Nausea | Gastrointestinal disorders | Group 1: SABER-Bupivacaine | 14 | 44 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: SABER-Bupivacaine | 0 | 44 |
| Total, all-cause mortality | Group 2: SABER-Bupivacaine | 0 | 47 |
| Total, all-cause mortality | Group 3: SABER-Placebo | 0 | 32 |
| Total, other adverse events | Group 1: SABER-Bupivacaine | 44 | 44 |
| Total, other adverse events | Group 2: SABER-Bupivacaine | 44 | 47 |
| Total, other adverse events | Group 3: SABER-Placebo | 31 | 32 |
| Total, serious adverse events | Group 1: SABER-Bupivacaine | 3 | 44 |
| Total, serious adverse events | Group 2: SABER-Bupivacaine | 2 | 47 |
| Total, serious adverse events | Group 3: SABER-Placebo | 1 | 32 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22510183 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00974350
GET https://conductscience.org/api/trials/v1/NCT00974350/results?page=2