Trial · NCT02574520
Trial of Extended Release Bupivacaine for Pain Relief After Surgery
NCT02574520, Phase 3, Completed, Durect; results first posted 2021-07-13
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Trial of Extended Release Bupivacaine for Pain Relief After Surgery. Trials, record NCT02574520. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02574520
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Extended Release Bupivacaine for Pain Relief After Surgery
- NCT number
- NCT02574520
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 399 participants, actual
- Lead sponsor
- Durect
- Conditions
- Post Operative Pain
- Interventions
- SABER-Bupivacaine (Part 1), SABER-Bupivacaine (Part 2), Saline Placebo, Bupivacaine HCl
- First posted
- 2015-10-14
- Last updated
- 2021-07-13
- Results first posted
- 2021-07-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Intensity on Movement From 0-48 Hours Post-Treatment | Assessed from 0 to 48 hours post-dose, summary measure (see description) reported. | A derived measure computed based on a patient-reported numerical pain rating scale assessing pain as a whole number from 0 (no pain) to 10 (worst pain imaginable) when the subject sits up from a supine position. This measure was evaluated by electronic diary at 13 planned time points from 0 to 48 hours post-treatment. The values reported are mean pain scores for each treatment group. |
| Secondary | Pain Intensity Using the NPRS-11 With Movement | Assessed from 0 to 72 hours post-dose, summary measure (see description) reported. | A derived measure computed based on a patient-reported numerical pain rating scale assessing pain as a whole number from 0 (no pain) to 10 (worst pain imaginable) when the subject sits up from a supine position. This measure was evaluated by electronic diary at 17 planned time points from 0 to 72 hours post-treatment. The values reported are mean pain scores for each treatment group. |
| Secondary | Total IV Morphine-equivalent Dose of Rescue Opioids | 0-72 hrs. post dose (after surgery) | IV morphine-equivalent dose |
| Secondary | Composite Endpoint of Silverman's Integrated Analgesic (SIA) Assessment Score | 0 to 72 hours | Score of Integrated Analgesia (SIA) is a composite endpoint that integrates pain assessment scores with opioid use over various collections of timepoints by ranking the pain score and the opioid use separately across treatments. After the scores are computed the means are calculated across time points to provide a single overall treatment effect. The composite SIA score ranges from -200 to 200 with -200 being the best case and 200 the worst case. |
| Secondary | Subjects Not Taking Rescue Medication From PACU Discharge to 72 Hours | From PACU Discharge to 72 Hours post-treatment | Pooled SABER-Bupivacaine parts 1 + 2 vs. Bupivacaine HCl |
| Secondary | Time to First Opioid Rescue Medication Use After Discharge From the PACU | From PACU Discharge to 72 Hours post-treatment | Pooled SABER-Bupivacaine parts 1 + 2 vs. Bupivacaine HCl |
| Secondary | Time to PACU Discharge Eligibility as Assessed by Modified Post-Anesthesia Discharge Scoring System (mPADSS) | From admission to discharge from PACU (Approximately 0 to 12 hours) | mPADSS is a tool used to determine eligibility for discharge from the PACU after ambulatory surgery. It includes an assessment of parameters such as vital signs, activity level, nausea/vomiting, pain, and surgical bleeding. For this trial, evaluation of eligibility for PACU discharge by mPADSS has been slightly modified to provide a standardized means of assessing eligibility for PACU discharge across multiple investigative sites and also ensures that nonmedical complications, such as a missing ride home, do not interfere with evaluation of test drug effects. |
Source ClinicalTrials.gov
Outcomes7
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 From 0-48 Hours Post-Treatment | Assessed from 0 to 48 hours post-dose, summary measure (see description) reported. | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 2) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified primary outcome measure that included the SABER-Bupivacaine (Part 1) arm or the Saline Placebo (Part 1) arm. | score on a scale | MEAN |
| SECONDARY | Pain Intensity Using the NPRS-11 With Movement | Assessed from 0 to 72 hours post-dose, summary measure (see description) reported. | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 1 and Part 2 combined) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified secondary outcome measure that included the Saline Placebo (Part 1) arm or the SABER-Bupivacaine (Part 1) arm as a standalone treatment group. | score on a scale | MEAN |
| SECONDARY | Total IV Morphine-equivalent Dose of Rescue Opioids | 0-72 hrs. post dose (after surgery) | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 1 and Part 2 combined) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified secondary outcome measure that included the Saline Placebo (Part 1) arm or the SABER-Bupivacaine (Part 1) arm as a standalone treatment group. | IV morphine equivalent (mg) | MEAN |
| SECONDARY | Composite Endpoint of Silverman's Integrated Analgesic (SIA) Assessment Score | 0 to 72 hours | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 1 and Part 2 combined) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified secondary outcome measure that included the Saline Placebo (Part 1) arm or the SABER-Bupivacaine (Part 1) arm as a standalone treatment group. | score on a scale | MEAN |
| SECONDARY | Subjects Not Taking Rescue Medication From PACU Discharge to 72 Hours | From PACU Discharge to 72 Hours post-treatment | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 1 and Part 2 combined) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified secondary outcome measure that included the Saline Placebo (Part 1) arm or the SABER-Bupivacaine (Part 1) arm as a standalone treatment group. | participants | NUMBER |
| SECONDARY | Time to First Opioid Rescue Medication Use After Discharge From the PACU | From PACU Discharge to 72 Hours post-treatment | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 1 and Part 2 combined) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified secondary outcome measure that included the Saline Placebo (Part 1) arm or the SABER-Bupivacaine (Part 1) arm as a standalone treatment group. | hours | MEDIAN |
| SECONDARY | Time to PACU Discharge Eligibility as Assessed by Modified Post-Anesthesia Discharge Scoring System (mPADSS) | From admission to discharge from PACU (Approximately 0 to 12 hours) | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 1 and Part 2 combined) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified secondary outcome measure that included the Saline Placebo (Part 1) arm or the SABER-Bupivacaine (Part 1) arm as a standalone treatment group. | hours | MEDIAN |
Source ClinicalTrials.gov
Results by group14
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 From 0-48 Hours Post-Treatment | Part 2/SABER-Bupivacaine | 5.55 | Standard Error 0.065 | score on a scale | |
| Pain Intensity on Movement From 0-48 Hours Post-Treatment | Part 2/Bupivacaine HCl | 5.87 | Standard Error 0.059 | score on a scale | |
| Pain Intensity Using the NPRS-11 With Movement | Part 1 and Part 2: SABER-Bupivacaine | 4.94 | Standard Error 0.049 | score on a scale | |
| Pain Intensity Using the NPRS-11 With Movement | Part 2: Bupivacaine HCl | 5.40 | Standard Error 0.052 | score on a scale | |
| Total IV Morphine-equivalent Dose of Rescue Opioids | Part 1 and Part 2: SABER-Bupivacaine | 21.4 | Standard Error 1.37 | IV morphine equivalent (mg) | |
| Total IV Morphine-equivalent Dose of Rescue Opioids | Part 2: Bupivacaine HCl | 22.6 | Standard Error 1.58 | IV morphine equivalent (mg) | |
| Composite Endpoint of Silverman's Integrated Analgesic (SIA) Assessment Score | Part 1 and Part 2: SABER-Bupivacaine | -17.3 | Standard Error 8.83 | score on a scale | |
| Composite Endpoint of Silverman's Integrated Analgesic (SIA) Assessment Score | Part 2: Bupivacaine HCl | -1.5 | Standard Error 9.33 | score on a scale | |
| Subjects Not Taking Rescue Medication From PACU Discharge to 72 Hours | Part 1 and Part 2: SABER-Bupivacaine | 57 | participants | ||
| Subjects Not Taking Rescue Medication From PACU Discharge to 72 Hours | Part 2: Bupivacaine HCl | 42 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SABER-Bupivacaine (Part 1) | 48 | |
| Overall Study | STARTED | Saline Placebo (Part 1) | 46 | |
| Overall Study | STARTED | SABER-Bupivacaine (Part 2) | 153 | |
| Overall Study | STARTED | Bupivacaine HCL (Part 2) | 152 | |
| Overall Study | Dosed | SABER-Bupivacaine (Part 1) | 46 | |
| Overall Study | Dosed | Saline Placebo (Part 1) | 46 | |
| Overall Study | Dosed | SABER-Bupivacaine (Part 2) | 148 | |
| Overall Study | Dosed | Bupivacaine HCL (Part 2) | 148 | |
| Overall Study | COMPLETED | SABER-Bupivacaine (Part 1) | 46 | |
| Overall Study | COMPLETED | Saline Placebo (Part 1) | 46 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events144
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 | Back pain | Musculoskeletal and connective tissue disorders | SABER-Bupivacaine (Part 1) | 3 | 45 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Saline Placebo (Part 1) | 3 | 47 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | SABER-Bupivacaine (Part 2) | 5 | 148 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Bupivacaine HCL (Part 2) | 11 | 148 | |
| other | Constipation (Solicited) | Gastrointestinal disorders | SABER-Bupivacaine (Part 1) | 20 | 45 | |
| other | Constipation (Solicited) | Gastrointestinal disorders | Saline Placebo (Part 1) | 19 | 47 | |
| other | Constipation (Solicited) | Gastrointestinal disorders | SABER-Bupivacaine (Part 2) | 65 | 148 | |
| other | Constipation (Solicited) | Gastrointestinal disorders | Bupivacaine HCL (Part 2) | 58 | 148 | |
| other | Constipation | Gastrointestinal disorders | SABER-Bupivacaine (Part 1) | 2 | 45 | |
| other | Constipation | Gastrointestinal disorders | Saline Placebo (Part 1) | 2 | 47 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SABER-Bupivacaine (Part 1) | 0 | 45 |
| Total, all-cause mortality | Saline Placebo (Part 1) | 0 | 47 |
| Total, all-cause mortality | SABER-Bupivacaine (Part 2) | 0 | 148 |
| Total, all-cause mortality | Bupivacaine HCL (Part 2) | 0 | 148 |
| Total, other adverse events | SABER-Bupivacaine (Part 1) | 43 | 45 |
| Total, other adverse events | Saline Placebo (Part 1) | 47 | 47 |
| Total, other adverse events | SABER-Bupivacaine (Part 2) | 148 | 148 |
| Total, other adverse events | Bupivacaine HCL (Part 2) | 146 | 148 |
| Total, serious adverse events | SABER-Bupivacaine (Part 1) | 1 | 45 |
| Total, serious adverse events | Saline Placebo (Part 1) | 0 | 47 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Part 1 and Part 2: SABER-Bupivacaine vs Part 2: Bupivacaine HCl: Subjects Not Taking Rescue Medication From PACU Discharge to 72 Hours |
Source Trial comparisons
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/NCT02574520
GET https://conductscience.org/api/trials/v1/NCT02574520/events?page=2