A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery

Postoperative Pain Clinical Trial

Official title:

A Double-Blind, Multi-Center, Placebo-Controlled Trial of SABER-Bupivacaine for Post-Operative Pain Control and Opioid Sparing/Opioid-Related Adverse Event Reduction Following Arthroscopic Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818363
• Other study ID #: C803-017
• Status: Completed
• Phase: Phase 2
• Start date: December 2008
• Est. completion date: October 2009

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 (if there are any side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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 to 65 years of age, scheduled for shoulder surgery.

• Patients must be healthy or have only mild systemic disease.

• Patients must have ECG wave form within normal limits

• Patients must have blood pressure within normal range.

• 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.

Exclusion Criteria:

• Patients with previous arthroscopic surgery or open surgery on the study shoulder.

• Patients with chronic pain conditions requiring continuous use of corticosteroids for greater than 3 months.

• Patients with fibromyalgia, rheumatoid arthritis, and/or sero-negative inflammatory arthropathies.

• Patients with a below normal calculated creatinine clearance.

• Patients who are pregnant or lactating.

• Patients currently receiving more than 20 mg of hydrocodone daily (or equivalent narcotic dose) on routine basis.

• Patients, who in the Investigator's opinion, have developed opioid tolerance.

• Patients with current or regular use of anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors at screening.

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

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

• Patients with known hypersensitivity to opioids.

• Patients with conditions contraindicated for use of opioids.

• 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

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• SABER-Bupivacaine
Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
• SABER-Placebo
Injectable Solution; 5.0 mL SABER-Placebo/Once

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Durect	Nycomed

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose.	Mean pain intensity on movement AUC (time normalized area under the curve) during the period 0 to 72 hours post-dose. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.	0 to 72 hours post-dose
Primary	Supplemental Opioid Use	Mean total morphine-equivalent dose during the period 0 to 72 hours post-dose	0 to 72 hours post-dose
Secondary	Number (Frequency) of Participants Reporting Opioid-related Adverse Events	Frequency of subject-reported opioid-related AEs during 0 to 72 hours (0 to 3 days) post-dose and during the trial: constipation, drowsiness, dizziness, nausea, vomiting, respiratory depression, and urinary retention.	0 to 72 hours post-dose
Secondary	Mean Pain Intensity on Movement AUC (Time-normalized AUC) During the Period 0 to 48 Hours Post-dose (0 to 2 Days Post-dose).	Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 hours post-dose (0 to 2 days post-dose). Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.	0 to 48 hours post-dose
Secondary	Supplemental Opioid Use	Mean total morphine-equivalent dose during the period 0 to 48 hours post-dose (0 to 2 days post-dose)	0 to 48 hours post-dose
Secondary	Time-to-first Use of Opioid Supplemental Pain Medication		0 to 14 days post-dose
Secondary	Severity of Opioid-related Side Effects		0 to 14 days post-dose