Bupivacaine Effectiveness and Safety in SABER® Trial

Postoperative Pain Clinical Trial

— BESST  

Official title:

Bupivacaine Effectiveness and Safety in SABER Trial (BESST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052012
• Other study ID #: C803-025
• Status: Completed
• Phase: Phase 3
• Start date: December 2009
• Est. completion date: September 2011

Study information

• Verified date: May 2021
• Source: Durect
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

The purpose of this study is to investigate safety (side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be able to read and understand the consent form, provide written consent, complete trial-related procedures, and communicate with the trial staff

• Males and females, 18 years of age and older scheduled to undergo elective general abdominal surgery

• Patients must be healthy or have only mild systemic disease

• BMI < 45

• Patients must have ECG wave form within normal limits

• Female and male patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial participation is completed

Exclusion Criteria:

• Patients who are pregnant or lactating

• Patients undergoing emergency surgery (unless full consent is obtained and all screening procedures are completed prior to surgery)

• Significant concomitant surgical procedure

• History of multiple prior laparotomy procedures

• Cancer with known metastases pre-operatively, which are suspected to impact post-operative recovery or pain

• Planned formation of stoma during surgery or plans to undergo another laparotomy procedure within 30 days post-operatively

• Pre-operative evidence of sepsis or septic shock

• Pre-operative evaluation that suggests a surgery may preclude full closure of the incision(s)

• Patients with current or regular use of systemic steroids, anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors, who cannot be withdrawn from these medications

• Patients with current or regular use of drugs known to significantly prolong the QTc interval

• Patients with known hypersensitivity to local anesthetic agents of the amide type (e.g. lidocaine, bupivacaine)

• Patients with known hypersensitivity to morphine

• Patients with conditions contraindicated for use of opioids

• Patients with atrial fibrillation/flutter or other non-sinus rhythm (including paced rhythm); left bundle branch block (LBBB); or the following conditions: right bundle branch block (RBBB) in presence of a cardiac disease, significant cardiomyopathy, and myocardial infarction within last 6 months

• Patients with a serum creatinine level two times more than the local laboratory normal limit

• Patients who have received greater than 600 mg morphine equivalent daily dose for three or more days per week in the month prior to the surgical procedure

• Patients who are currently being treated with methadone, or history of methadone use within the previous 6 months

• Patients with known or suspected abuse of opioids or other illicit drugs

• Patients with known or suspected alcohol abuse

• Participation in another clinical trial at the same time or within 30 days of this trial

• Patients who, in the Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason

Related Conditions & MeSH terms

• Abdominal Surgery
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• SABER-Bupivacaine
Injectable Extended Release Solution; SABER-Bupivacaine /Once
• Bupivacaine HCl
Injectable Solution; Bupivacaine HCl /Once
• SABER-Placebo
Injectable Solution; SABER-Placebo/Once

Locations

Country	Name	City	State
Australia	DURECT Study Site	Box Hill	Victoria
Australia	DURECT Study Site	Ringwood East	Victoria
Australia	DURECT Study Site	Woodville South	South Australia
New Zealand	DURECT Study Site	Christchurch
United States	DURECT Study Site	Arcadia	California
United States	DURECT Study Site	Birmingham	Alabama
United States	DURECT Study Site	Boston	Massachusetts
United States	DURECT Study Site	Columbus	Ohio
United States	DURECT Study Site	Duluth	Minnesota
United States	DURECT Study Site	Durham	North Carolina
United States	DURECT Study Site	Florence	Alabama
United States	DURECT Study Site	Fontana	California
United States	DURECT Study Site	Hershey	Pennsylvania
United States	DURECT Study Site	Houston	Texas
United States	DURECT Study Site	Indianapolis	Indiana
United States	DURECT Study Site	Laguna Hills	California
United States	DURECT Study Site	Mobile	Alabama
United States	DURECT Study Site	Mobile	Alabama
United States	DURECT Study Site	Montgomery	Alabama
United States	DURECT Study Site	New York	New York
United States	DURECT Study Site	Pasadena	California
United States	DURECT Study Site	Powder Springs	Georgia
United States	DURECT Study Site	Sheffield	Alabama
United States	DURECT Study Site	Tampa	Florida
United States	DURECT Study Site	Temple	Texas
United States	DURECT Study Site	Troy	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Durect	Hospira, now a wholly owned subsidiary of Pfizer, Nycomed

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Pain Intensity on Movement	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.	0 to 72 hours post-dose
Primary	Supplemental Opioid Use	Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.	0-72 hours post dose
Secondary	Mean Pain Intensity on Movement	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.	0 to 48 hours post-dose
Secondary	Total Morphine-equivalent Dose	Total morphine-equivalent dose during 0-48 hours post dose.	0-48 hours post dose
Secondary	Proportion (Percent) of Patients Who Have Evidence of a Wound Infection	From Surgical Wound Healing and Local Tissue Condition Evaluation	0 to 14 days post-dose (Visits 3 and 4)
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	AEs include: nausea, vomiting, constipation, dizziness, somnolence, urinary retention, respiratory depression	0 to 30 days post-dose
Secondary	Pain Intensity at Rest AUC During 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.	0-72 hours post dose
Secondary	Mean Pain Intensity at Rest AUC During 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.	0-48 hours post dose