Trial · NCT01052012

Bupivacaine Effectiveness and Safety in SABER® Trial

NCT01052012, Phase 3, Completed, Durect; results first posted 2021-06-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bupivacaine Effectiveness and Safety in SABER® Trial. Trials, record NCT01052012. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01052012

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bupivacaine Effectiveness and Safety in SABER® Trial
NCT number: NCT01052012
Status: Completed
Phases: Phase 3
Enrollment: 331 participants, actual
Lead sponsor: Durect
Conditions: Postoperative Pain, Abdominal Surgery
Interventions: SABER-Bupivacaine, Bupivacaine HCl, SABER-Placebo
First posted: 2010-01-20
Last updated: 2021-06-01
Results first posted: 2021-06-01

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Pain Intensity on Movement	0 to 72 hours post-dose	Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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	Supplemental Opioid Use	0-72 hours post dose	Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.
Secondary	Mean Pain Intensity on Movement	0 to 48 hours post-dose	Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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	Total Morphine-equivalent Dose	0-48 hours post dose	Total morphine-equivalent dose during 0-48 hours post dose.
Secondary	Proportion (Percent) of Patients Who Have Evidence of a Wound Infection	0 to 14 days post-dose (Visits 3 and 4)	From Surgical Wound Healing and Local Tissue Condition Evaluation
Secondary	Time-to-first Use of Opioid Rescue Medication	0 to 14 days post-dose (Time from extubation until first opioid use)
Secondary	Number (Incidence) of Participants With Opioid-related Side Effects	0 to 30 days post-dose	AEs include: nausea, vomiting, constipation, dizziness, somnolence, urinary retention, respiratory depression
Secondary	Pain Intensity at Rest AUC During 0-72 Hours Post Dose	0-72 hours post dose	Mean pain intensity at rest AUC during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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	Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose	0-48 hours post dose	Mean pain intensity at rest AUC during the period 0 to 48 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Pain Intensity on Movement	0 to 72 hours post-dose	ITT Population	score on a scale	LEAST_SQUARES_MEAN
PRIMARY	Supplemental Opioid Use	0-72 hours post dose	ITT Population	Milligram equivalents	MEDIAN
SECONDARY	Mean Pain Intensity on Movement	0 to 48 hours post-dose	ITT Population	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Total Morphine-equivalent Dose	0-48 hours post dose	ITT Population	mg IV Morphine equivalents	MEDIAN
SECONDARY	Proportion (Percent) of Patients Who Have Evidence of a Wound Infection	0 to 14 days post-dose (Visits 3 and 4)	ITT Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time-to-first Use of Opioid Rescue Medication	0 to 14 days post-dose (Time from extubation until first opioid use)	ITT Population	Hours	MEDIAN
SECONDARY	Number (Incidence) of Participants With Opioid-related Side Effects	0 to 30 days post-dose	ITT Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pain Intensity at Rest AUC During 0-72 Hours Post Dose	0-72 hours post dose	ITT Population	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose	0-48 hours post dose	ITT Population	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group72

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Pain Intensity on Movement	Cohort 1-POSIMIR	4.9	95% Confidence Interval 4.0 to 5.7	score on a scale
Mean Pain Intensity on Movement	Cohort 1-Bupivacaine HCl	5.0	95% Confidence Interval 4.7 to 6.8	score on a scale
Mean Pain Intensity on Movement	Cohort 2-POSIMIR	2.8	95% Confidence Interval 2.0 to 3.6	score on a scale
Mean Pain Intensity on Movement	Cohort 2-Bupivacaine HCl	3.9	95% Confidence Interval 3.0 to 4.8	score on a scale
Mean Pain Intensity on Movement	Cohort 3-POSIMIR	4.8	95% Confidence Interval 4.4 to 5.2	score on a scale
Mean Pain Intensity on Movement	Cohort 3-Placebo	5.1	95% Confidence Interval 4.7 to 5.6	score on a scale
Supplemental Opioid Use	Cohort 1-POSIMIR	87.0	Inter-Quartile Range 30.0 to 157.0	Milligram equivalents
Supplemental Opioid Use	Cohort 1-Bupivacaine HCl	63.0	Inter-Quartile Range 34.0 to 152.0	Milligram equivalents
Supplemental Opioid Use	Cohort 2-POSIMIR	17.0	Inter-Quartile Range 8.0 to 26.0	Milligram equivalents
Supplemental Opioid Use	Cohort 2-Bupivacaine HCl	22.5	Inter-Quartile Range 12.5 to 34.5	Milligram equivalents

1 to 10 of 72Source ClinicalTrials.gov

See all 72 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cohort 1-POSIMIR	32
Overall Study	STARTED	Cohort 1-Bupivacaine HCl	23
Overall Study	STARTED	Cohort 2-POSIMIR	30
Overall Study	STARTED	Cohort 2-Bupivacaine HCl	20
Overall Study	STARTED	Cohort 3-POSIMIR	140
Overall Study	STARTED	Cohort 3-Placebo	86
Overall Study	COMPLETED	Cohort 1-POSIMIR	28
Overall Study	COMPLETED	Cohort 1-Bupivacaine HCl	17
Overall Study	COMPLETED	Cohort 2-POSIMIR	30
Overall Study	COMPLETED	Cohort 2-Bupivacaine HCl	19

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events882

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	Nausea	Gastrointestinal disorders	Cohort 1-POSIMIR	16	30	18
other	Nausea	Gastrointestinal disorders	Cohort 1-Bupivacaine HCl	9	18	11
other	Nausea	Gastrointestinal disorders	Cohort 2-POSIMIR	17	30	23
other	Nausea	Gastrointestinal disorders	Cohort 2-Bupivacaine HCl	14	20	20
other	Nausea	Gastrointestinal disorders	Cohort 3-POSIMIR	77	129	80
other	Nausea	Gastrointestinal disorders	Cohort 3-Placebo	40	78	42
other	Vomiting	Gastrointestinal disorders	Cohort 1-POSIMIR	9	30	12
other	Vomiting	Gastrointestinal disorders	Cohort 1-Bupivacaine HCl	2	18	2
other	Vomiting	Gastrointestinal disorders	Cohort 2-POSIMIR	9	30	13
other	Vomiting	Gastrointestinal disorders	Cohort 2-Bupivacaine HCl	7	20	10

1 to 10 of 882Source ClinicalTrials.gov

See all 882 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort 1-POSIMIR	0	30
Total, all-cause mortality	Cohort 1-Bupivacaine HCl	0	18
Total, all-cause mortality	Cohort 2-POSIMIR	0	30
Total, all-cause mortality	Cohort 2-Bupivacaine HCl	0	20
Total, all-cause mortality	Cohort 3-POSIMIR	1	129
Total, all-cause mortality	Cohort 3-Placebo	0	78
Total, other adverse events	Cohort 1-POSIMIR	30	30
Total, other adverse events	Cohort 1-Bupivacaine HCl	17	18
Total, other adverse events	Cohort 2-POSIMIR	28	30
Total, other adverse events	Cohort 2-Bupivacaine HCl	20	20

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01052012

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