Postoperative PainPhase 2NCT00818363
A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery
A Phase 2 study testing SABER-Bupivacaine in people with Postoperative Pain, run by Durect at 9 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- SABER-Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Dec 2008to Oct 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Australia7 sites
Study site
Adelaide, South Australia, 5000
Study site
Geelong, Victoria, 3220
Study site
Hampton, Victoria, 3188
Study site
Kippa-Ring, Queensland, 4021
Study site
Ringwood East, Victoria, 3135
Study site
Toorak Gardens, South Australia, 5065
Study site
Westmead, New South Wales, 2145
About this study
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
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.
- Conditions
- Postoperative Pain
- Being tested
- SABER-Bupivacaine, SABER-Placebo
- Keywords
- Postoperative pain, shoulder surgery, opioid
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SABER-BupivacaineDrug
Also called POSIMIR® bupivacaine solution
Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
SABER-PlaceboDrug
Injectable Solution; 5.0 mL SABER-Placebo/Once
| Study group | Role | What they receive |
|---|---|---|
| Group 1: SABER-Bupivacaine | Experimental | 5.0 mL SABER-Bupivacaine/Once Receives: Drug: SABER-Bupivacaine |
| Group 2: SABER-Placebo | Placebo comparator | 5.0 mL SABER-Placebo/Once Receives: Drug: SABER-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to 72 hours post-dose
Supplemental Opioid Use
Mean total morphine-equivalent dose during the period 0 to 72 hours post-dose
Measured: 0 to 72 hours post-dose
Secondary outcomes (5)
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.
Measured: 0 to 72 hours 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).
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.
Measured: 0 to 48 hours post-dose
Supplemental Opioid Use
Mean total morphine-equivalent dose during the period 0 to 48 hours post-dose (0 to 2 days post-dose)
Measured: 0 to 48 hours post-dose
Time-to-first Use of Opioid Supplemental Pain Medication
Measured: 0 to 14 days post-dose
Severity of Opioid-related Side Effects
Measured: 0 to 14 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durect
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nycomed
- Responsible party
- Sponsor
- Investigators
- Dmitri Lissin, MD, Study director, Durect
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818363
- Sponsor's protocol ID
- C803-017
- Status last verified
- May 2021
- First submitted
- 5 Jan 2009
- Last updated
- 1 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hadj A, Hadj A, Hadj A, Rosenfeldt F, Nicholson D, Moodie J, Turner R, Watts R, Fletcher I, Abrouk N, Lissin D. Safety and efficacy of extended-release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial. ANZ J Surg. 2012 Apr;82(4):251-7. doi: 10.1111/j.1445-2197.2011.05754.x. Epub 2011 Jun 24.
PubMed 22510183
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00818363
- Acronym / sponsor ID
- C803-017
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, shoulder surgery, opioid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- DurectIndustry (pharma, biotech, devices)
- Collaborators
- Nycomed
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 7 Jan 2009 (estimated)
- Results
- Posted 1 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: SABER-Bupivacaine | Experimental | Drug: SABER-Bupivacaine5.0 mL SABER-Bupivacaine/Once |
| Group 2: SABER-Placebo | Placebo comparator | Drug: SABER-Placebo5.0 mL SABER-Placebo/Once |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SABER-BupivacaineAlso: POSIMIR® bupivacaine solutionInjectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once | Drug | Group 1: SABER-Bupivacaine |
| SABER-PlaceboInjectable Solution; 5.0 mL SABER-Placebo/Once | Drug | Group 2: SABER-Placebo |
Primary outcome
Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose.
Time frame: 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.
Supplemental Opioid Use
Time frame: 0 to 72 hours post-dose
Mean total morphine-equivalent dose during the period 0 to 72 hours post-dose
5 secondary outcomes
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Time frame: 0 to 72 hours 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).
Time frame: 0 to 48 hours post-dose
Supplemental Opioid Use
Time frame: 0 to 48 hours post-dose
Time-to-first Use of Opioid Supplemental Pain Medication
Time frame: 0 to 14 days post-dose
Severity of Opioid-related Side Effects
Time frame: 0 to 14 days post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22510183Hadj A, Hadj A, Hadj A, Rosenfeldt F, Nicholson D, Moodie J, Turner R, Watts R, Fletcher I, Abrouk N, Lissin D. Safety and efficacy of extended-release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial. ANZ J Surg. 2012 Apr;82(4):251-7. doi: 10.1111/j.1445-2197.2011.05754.x. Epub 2011 Jun 24.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitri Lissin, MD study director
Durect
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SABER-Bupivacaine in people with Postoperative Pain, run by Durect at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose. (time frame: 0 to 72 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00818363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.