A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair

• Sponsor: Durect (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00974350
• Collaborator: Nycomed (Industry)
• Enrollment: 124
• Locations: 5
• Arms: 3
• Duration (Months): 9
• Patients Per Site: 24.8
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Hernia; Surgery	Drug: SABER-Bupivacaine; Drug: SABER-Bupivacaine; Drug: SABER-Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled, Pharmacodynamic and Pharmacokinetic Dose Response Study of SABER-Bupivacaine Instilled Into the Wound in Patients Undergoing Open Inguinal Hernia Repair
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: SABER-Bupivacaine 2.5 mL SABER-Bupivacaine/Once	Drug: SABER-Bupivacaine; Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once
Experimental: Group 2: SABER-Bupivacaine 5.0 mL SABER-Bupivacaine/Once	Drug: SABER-Bupivacaine; Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once; Other Names: POSIMIR® bupivacaine solution
Placebo Comparator: Group 3: SABER-Placebo 2.5 mL or 5.0 mL SABER-Placebo/Once	Drug: SABER-Placebo; Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once

Outcome Measures

Primary Outcome Measures

1. 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.

2. Proportion (Percent) of Patients Using Supplemental Opioids [0 to 14 days post-dose]

Secondary Outcome Measures

1. 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.

2. 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).

3. Supplemental Opioid Use [0 to 14 days post-dose]

4. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Cairns	Queensland	Australia	4870
2		Sunnybank	Queensland	Australia	4109
3		Port Lincoln	South Australia	Australia	5606
4		Ringwood East	Victoria	Australia	3135
5		Hamilton		New Zealand

Sponsors and Collaborators

• Durect
• Nycomed

Investigators

• Study Director: Dmitri Lissin, MD, Durect

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00974350
• Other Study ID Numbers: CLIN803-006-0006
• First Posted: Sep 10, 2009
• Last Update Posted: May 27, 2021
• Last Verified: May 1, 2021

• Keywords provided by , ,: Post-operative pain; hernia surgery; opioid
• Additional relevant MeSH terms: Hernia; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Group 1: SABER-Bupivacaine	Group 2: SABER-Bupivacaine	Group 3: SABER-Placebo
Arm/Group Description	2.5 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once	5.0 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once	2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once (SABER-Placebo 2.5 mL or 5.0 mL, as randomly assigned)
Period Title: Overall Study
STARTED	45	47	32
COMPLETED	42	47	31
NOT COMPLETED	3	0	1

Baseline Characteristics

Arm/Group Title	Group 1: SABER-Bupivacaine	Group 2: SABER-Bupivacaine	Group 3: SABER-Placebo	Total
Arm/Group Description	2.5 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once	5.0 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once	2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once	Total of all reporting groups
Overall Participants	44	47	32	123
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.9 (11.82)	48.6 (13.04)	50.3 (9.26)	48.11 (11.76)
Sex: Female, Male (Count of Participants)
Female	2 4.5%	2 4.3%	0 0%	4 3.3%
Male	42 95.5%	45 95.7%	32 100%	119 96.7%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.5 (3.74)	26.3 (2.92)	26.9 (3.68)	26.55 (3.41)

Outcome Measures

1. Primary Outcome

Title	Pain Intensity on Movement
Description	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.
Time Frame	1 to 72 hours post-dose

Outcome Measure Data

Analysis Population Description

ITT population (patients with data available)

Arm/Group Title	Group 1: SABER-Bupivacaine	Group 2: SABER-Bupivacaine	Group 3: SABER-Placebo
Arm/Group Description	2.5 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once	5.0 mL SABER-Bupivacaine /Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once	2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
Measure Participants	43	47	32
Least Squares Mean (Standard Error) [score on a scale]	3.4 (0.26)	2.7 (0.25)	3.9 (0.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 2: SABER-Bupivacaine, Group 3: SABER-Placebo
	Comments	Pain Intensity on Movement AUCs1-72 hours Including Pain Assessed Upon Taking Opioid Rescue - ITT
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0031
	Comments
	Method	ANOVA
	Comments	LS Mean difference from SABER-Placebo
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.14
	Confidence Interval	(2-Sided) 95%; -1.84 to -0.44
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.353
	Estimation Comments

2. Primary Outcome

Title	Proportion (Percent) of Patients Using Supplemental Opioids
Time Frame	0 to 14 days post-dose

Outcome Measure Data

Analysis Population Description

ITT population (patients with data available)

Arm/Group Title	Group 1: SABER-Bupivacaine	Group 2: SABER-Bupivacaine	Group 3: SABER-Placebo
Arm/Group Description	2.5 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once	5.0 mL SABER-Bupivacaine /Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once	2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
Measure Participants	43	47	32
Count of Participants [Participants]	31 70.5%	25 53.2%	23 71.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 2: SABER-Bupivacaine, Group 3: SABER-Placebo
	Comments	Proportion of Patients Not Taking Any Supplemental Opioid Analgesic Medication
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0909
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by pooled study sites

3. Secondary Outcome

Title	Pain Intensity
Description	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.
Time Frame	1 to 48 hours post-dose

Outcome Measure Data

Analysis Population Description

ITT population (patients with data available)

Arm/Group Title	Group 1: SABER-Bupivacaine	Group 2: SABER-Bupivacaine	Group 3: SABER-Placebo
Arm/Group Description	2.5 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once	5.0 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once	2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
Measure Participants	43	47	32
Least Squares Mean (Standard Error) [score on a scale]	3.4 (0.26)	2.8 (0.26)	4.1 (0.30)

4. Secondary Outcome

Title	Treatment Satisfaction
Description	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).
Time Frame	1 to 5 days post-dose

Outcome Measure Data

Analysis Population Description

ITT population (patients with data available)

Arm/Group Title	Group 1: SABER-Bupivacaine	Group 2: SABER-Bupivacaine	Group 3: SABER-Placebo
Arm/Group Description	2.5 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once	5.0 mL SABER-Bupivacaine /Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once	2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
Measure Participants	42	47	30
Very Dissatisfied	2 4.5%	2 4.3%	0 0%
Dissatisfied	1 2.3%	0 0%	2 6.3%
Slightly Dissatisfied	1 2.3%	2 4.3%	0 0%
Slightly Satisfied	2 4.5%	4 8.5%	4 12.5%
Satisfied	15 34.1%	16 34%	12 37.5%
Very Satisfied	21 47.7%	21 44.7%	11 34.4%
Very Dissatisfied	0 0%	0 0%	1 3.1%
Dissatisfied	1 2.3%	0 0%	0 0%
Slightly Dissatisfied	1 2.3%	2 4.3%	2 6.3%
Slightly Satisfied	4 9.1%	3 6.4%	4 12.5%
Satisfied	15 34.1%	19 40.4%	12 37.5%
Very Satisfied	21 47.7%	19 40.4%	11 34.4%
Very Dissatisfied	0 0%	0 0%	0 0%
Dissatisfied	0 0%	0 0%	0 0%
Slightly Dissatisfied	0 0%	0 0%	1 3.1%
Slightly Satisfied	3 6.8%	2 4.3%	2 6.3%
Satisfied	13 29.5%	23 48.9%	14 43.8%
Very Satisfied	26 59.1%	20 42.6%	11 34.4%
Very Dissatisfied	0 0%	0 0%	0 0%
Dissatisfied	0 0%	0 0%	1 3.1%
Slightly Dissatisfied	0 0%	0 0%	0 0%
Slightly Satisfied	2 4.5%	1 2.1%	3 9.4%
Satisfied	18 40.9%	21 44.7%	12 37.5%
Very Satisfied	18 40.9%	22 46.8%	13 40.6%
Very Dissatisfied	0 0%	0 0%	0 0%
Dissatisfied	0 0%	0 0%	0 0%
Slightly Dissatisfied	1 2.3%	0 0%	1 3.1%
Slightly Satisfied	1 2.3%	1 2.1%	1 3.1%
Satisfied	16 36.4%	17 36.2%	11 34.4%
Very Satisfied	21 47.7%	24 51.1%	14 43.8%

5. Secondary Outcome

Title	Supplemental Opioid Use
Time Frame	0 to 14 days post-dose

Outcome Measure Data

Analysis Population Description

ITT population (patients with data available)

Arm/Group Title	Group 1: SABER-Bupivacaine	Group 2: SABER-Bupivacaine	Group 3: SABER-Placebo
Arm/Group Description	2.5 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once	5.0 mL SABER-Bupivacaine /Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once	2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
Measure Participants	43	47	32
Mean (Standard Deviation) [Total morphine equivalent dose (mg)]	17.7 (25.36)	12.5 (17.63)	38.4 (60.24)

6. Secondary Outcome

Title	Mean Function Activities (Modified Brief Pain Inventory)
Description	In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference)
Time Frame	1 to 5 days post-dose

Outcome Measure Data

Analysis Population Description

ITT population (patients with data available)

Arm/Group Title	Group 1: SABER-Bupivacaine	Group 2: SABER-Bupivacaine	Group 3: SABER-Placebo
Arm/Group Description	2.5 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once	5.0 mL SABER-Bupivacaine /Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once	2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
Measure Participants	43	47	32
get out of bed (Day 1)	3.2 (2.56)	2.7 (2.63)	4.6 (3.49)
get out of bed (Day 2)	3.0 (2.37)	2.4 (1.88)	3.0 (2.50)
get out of bed (Day 3)	2.5 (2.09)	1.5 (1.71)	2.1 (2.01)
get out of bed (Day 4)	1.7 (1.88)	1.1 (1.27)	1.9 (2.12)
get out of bed (Day 5)	1.7 (1.83)	1.1 (1.33)	1.4 (1.60)
Ability to walk (Day 1)	3.5 (2.76)	2.7 (2.74)	3.9 (3.14)
Ability to walk (Day 2)	2.8 (2.25)	2.3 (2.09)	2.3 (2.35)
Ability to walk (Day 3)	2.5 (2.02)	1.4 (1.62)	1.5 (1.77)
Ability to walk (Day 4)	2.0 (1.90)	1.0 (1.29)	1.7 (2.45)
Ability to walk (Day 5)	1.8 (1.89)	1.3 (1.47)	1.3 (1.46)
Ability To Interact With Visitors (Day 1)	1.1 (2.08)	0.7 (1.32)	1.4 (1.59)
Ability To Interact With Visitors (Day 2)	1.0 (1.56)	1.0 (1.62)	1.1 (1.31)
Ability To Interact With Visitors (Day 3)	0.7 (1.22)	0.4 (0.84)	0.6 (0.63)
Ability To Interact With Visitors (Day 4)	0.7 (1.33)	0.4 (0.73)	0.5 (1.21)
Ability To Interact With Visitors (Day 5)	0.5 (1.17)	0.4 (0.74)	0.3 (0.61)
Ability To Fall Asleep (Day 1)	2.7 (2.37)	2.0 (2.31)	2.6 (2.09)
Ability To Fall Asleep (Day 2)	2.0 (2.25)	1.3 (1.61)	1.8 (1.92)
Ability To Fall Asleep (Day 3)	1.5 (1.61)	0.9 (1.14)	1.2 (1.31)
Ability To Fall Asleep (Day 4)	1.4 (2.03)	0.6 (1.14)	1.3 (2.21)
Ability To Fall Asleep (Day 5)	1.1 (1.52)	0.5 (0.74)	0.8 (1.45)
Ability To Stay Asleep (Day 1)	2.6 (2.49)	2.2 (2.58)	2.1 (2.28)
Ability To Stay Asleep (Day 2)	2.0 (2.26)	1.4 (1.79)	1.8 (2.01)
Ability To Stay Asleep (Day 3)	1.4 (1.67)	0.7 (1.01)	1.2 (1.50)
Ability To Stay Asleep (Day 4)	1.2 (1.71)	0.5 (0.90)	1.3 (2.33)
Ability To Stay Asleep (Day 5)	1.1 (1.50)	0.7 (0.92)	0.7 (1.43)
Ability To Eat (Day 1)	1.2 (1.89)	0.4 (0.94)	0.9 (1.58)
Ability To Eat (Day 2)	0.9 (1.61)	0.3 (0.72)	0.5 (1.04)
Ability To Eat (Day 3)	0.5 (1.06)	0.2 (0.55)	0.4 (1.19)
Ability To Eat (Day 4)	0.4 (1.11)	0.2 (0.46)	0.3 (0.86)
Ability To Eat (Day 5)	0.3 (0.98)	0.1 (0.36)	0.3 (0.86)
Ability To Deep Breath (Day 1)	1.5 (2.51)	0.7 (1.27)	1.5 (2.32)
Ability To Deep Breath (Day 2)	1.2 (2.06)	0.8 (1.43)	1.1 (1.82)
Ability To Deep Breath (Day 3)	1.4 (2.39)	0.5 (1.06)	0.7 (1.28)
Ability To Deep Breath (Day 4)	1.1 (1.93)	0.5 (0.90)	0.7 (1.56)
Ability To Deep Breath (Day 5)	0.8 (1.86)	0.4 (0.86)	0.4 (0.69)
Ability To Cough (Day 1)	4.4 (3.41)	3.8 (3.10)	5.7 (3.06)
Ability To Cough (Day 2)	4.4 (3.10)	3.4 (2.61)	5.0 (2.99)
Ability To Cough (Day 3)	3.9 (3.08)	2.9 (2.28)	4.5 (3.12)
Ability To Cough (Day 4)	3.2 (2.76)	2.3 (2.02)	3.5 (2.97)
Ability To Cough (Day 5)	3.0 (2.77)	2.2 (1.97)	3.1 (2.71)

Adverse Events

Time Frame	Through study completion, approximately 14 days
Arm/Group Title	Group 1: SABER-Bupivacaine		Group 2: SABER-Bupivacaine		Group 3: SABER-Placebo
Arm/Group Description	2.5 mL SABER-Bupivacaine /Once SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once		5.0 mL SABER-Bupivacaine /Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine (660 mg) /Once		2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
All Cause Mortality
	Group 1: SABER-Bupivacaine		Group 2: SABER-Bupivacaine		Group 3: SABER-Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/47 (0%)		0/32 (0%)
Serious Adverse Events
	Group 1: SABER-Bupivacaine		Group 2: SABER-Bupivacaine		Group 3: SABER-Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/44 (6.8%)		2/47 (4.3%)		1/32 (3.1%)
Cardiac disorders
Acute coronary syndrome	1/44 (2.3%)		0/47 (0%)		0/32 (0%)
Injury, poisoning and procedural complications
Postoperative wound complication	1/44 (2.3%)		0/47 (0%)		0/32 (0%)
Nervous system disorders
Syncope	0/44 (0%)		1/47 (2.1%)		1/32 (3.1%)
Syncope vasovagal	1/44 (2.3%)		1/47 (2.1%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: SABER-Bupivacaine		Group 2: SABER-Bupivacaine		Group 3: SABER-Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	44/44 (100%)		44/47 (93.6%)		31/32 (96.9%)
Cardiac disorders
Bradycardia	9/44 (20.5%)		12/47 (25.5%)		7/32 (21.9%)
Ear and labyrinth disorders
Tinnitus	3/44 (6.8%)		6/47 (12.8%)		5/32 (15.6%)
Gastrointestinal disorders
Constipation	17/44 (38.6%)		13/47 (27.7%)		18/32 (56.3%)
Nausea	14/44 (31.8%)		9/47 (19.1%)		10/32 (31.3%)
Vomiting	3/44 (6.8%)		1/47 (2.1%)		2/32 (6.3%)
General disorders
Application site discoloration	10/44 (22.7%)		11/47 (23.4%)		6/32 (18.8%)
Pyrexia	1/44 (2.3%)		2/47 (4.3%)		2/32 (6.3%)
Infections and infestations
Incision site infection	0/44 (0%)		0/47 (0%)		2/32 (6.3%)
Injury, poisoning and procedural complications
Incision site oedema	3/44 (6.8%)		2/47 (4.3%)		1/32 (3.1%)
Musculoskeletal and connective tissue disorders
Back pain	4/44 (9.1%)		2/47 (4.3%)		0/32 (0%)
Nervous system disorders
Dizziness	14/44 (31.8%)		11/47 (23.4%)		10/32 (31.3%)
Dysgeusia	6/44 (13.6%)		5/47 (10.6%)		5/32 (15.6%)
Headache	11/44 (25%)		9/47 (19.1%)		7/32 (21.9%)
Paraesthesia	9/44 (20.5%)		5/47 (10.6%)		2/32 (6.3%)
Somnolence	20/44 (45.5%)		18/47 (38.3%)		16/32 (50%)
Skin and subcutaneous tissue disorders
Pruritus	13/44 (29.5%)		11/47 (23.4%)		7/32 (21.9%)
Vascular disorders
Hypotension	3/44 (6.8%)		2/47 (4.3%)		3/32 (9.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.