Postoperative PainPhase 2NCT00974350
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
A Phase 2 study testing SABER-Bupivacaine in people with Postoperative Pain and Hernia, run by Durect at 5 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, Hernia, Surgery
- 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
- 124 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2007to Oct 2007
- 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
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Australia4 sites
Study site
Cairns, Queensland, 4870
Study site
Port Lincoln, South Australia, 5606
Study site
Ringwood East, Victoria, 3135
Study site
Sunnybank, Queensland, 4109
About this study
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
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.
- Conditions
- Postoperative Pain, Hernia, Surgery
- Being tested
- SABER-Bupivacaine, SABER-Placebo
- Keywords
- Post-operative pain, hernia surgery, opioid
- Medical subject headings
- Pain, Postoperative, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SABER-BupivacaineDrug
Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once
SABER-BupivacaineDrug
Also called POSIMIR® bupivacaine solution
Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
SABER-PlaceboDrug
Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
| Study group | Role | What they receive |
|---|---|---|
| Group 1: SABER-Bupivacaine | Experimental | 2.5 mL SABER-Bupivacaine/Once Receives: Drug: SABER-Bupivacaine |
| Group 2: SABER-Bupivacaine | Experimental | 5.0 mL SABER-Bupivacaine/Once Receives: Drug: SABER-Bupivacaine |
| Group 3: SABER-Placebo | Placebo comparator | 2.5 mL or 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.
Pain Intensity on Movement
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.
Measured: 1 to 72 hours post-dose
Proportion (Percent) of Patients Using Supplemental Opioids
Measured: 0 to 14 days post-dose
Secondary outcomes (4)
Pain Intensity
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.
Measured: 1 to 48 hours post-dose
Treatment Satisfaction
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).
Measured: 1 to 5 days post-dose
Supplemental Opioid Use
Measured: 0 to 14 days post-dose
Mean Function Activities (Modified Brief Pain Inventory)
In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference)
Measured: 1 to 5 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 posted10 Sep 2009 (estimated)
- Study startJan 2007
- Primary completionOct 2007
- Study completionOct 2007
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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durect
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nycomed
- Investigators
- Dmitri Lissin, MD, Study director, Durect
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974350
- Sponsor's protocol ID
- CLIN803-006-0006
- Status last verified
- May 2021
- First submitted
- 8 Sep 2009
- Last updated
- 27 May 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 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00974350
- Acronym / sponsor ID
- CLIN803-006-0006
- Conditions
- Postoperative Pain, Hernia, Surgery
- Keywords
- Post-operative pain, hernia surgery, opioid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- DurectIndustry (pharma, biotech, devices)
- Collaborators
- Nycomed
- Study start
- Jan 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Posted 5 May 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: SABER-Bupivacaine | Experimental | Drug: SABER-Bupivacaine2.5 mL SABER-Bupivacaine/Once |
| Group 2: SABER-Bupivacaine | Experimental | Drug: SABER-Bupivacaine5.0 mL SABER-Bupivacaine/Once |
| Group 3: SABER-Placebo | Placebo comparator | Drug: SABER-Placebo2.5 mL or 5.0 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 (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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-BupivacaineInjectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once | Drug | Group 1: SABER-Bupivacaine |
| SABER-BupivacaineAlso: POSIMIR® bupivacaine solutionInjectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once | Drug | Group 2: SABER-Bupivacaine |
| SABER-PlaceboInjectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once | Drug | Group 3: SABER-Placebo |
Primary outcome
Pain Intensity on Movement
Time frame: 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.
Proportion (Percent) of Patients Using Supplemental Opioids
Time frame: 0 to 14 days post-dose
4 secondary outcomes
Pain Intensity
Time frame: 1 to 48 hours post-dose
Treatment Satisfaction
Time frame: 1 to 5 days post-dose
Supplemental Opioid Use
Time frame: 0 to 14 days post-dose
Mean Function Activities (Modified Brief Pain Inventory)
Time frame: 1 to 5 days post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
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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
5 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 and Hernia, run by Durect at 5 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 6 inclusion and 11 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 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 5 May 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?
Pain Intensity on Movement (time frame: 1 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 NCT00974350, 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 27 May 2021.