Postoperative PainPhase 2NCT00626886
Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy
A Phase 2 study testing Bupivacaine Collagen Sponge in people with Postoperative Pain and Inguinal Hernia, run by Innocoll at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after herniorrhaphy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Postoperative Pain, Inguinal Hernia
- What is being tested?
- Bupivacaine Collagen Sponge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2008to 29 Jan 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has body mass index (BMI) > 19 and < 40 kg/m2.
- Has a planned unilateral inguinal herniorrhaphy (open mesh, tension free technique) to be performed according to standard surgical technique under general anesthesia.
- Has a risk classification of I, II or III according to the ASA.
- Is free of other physical or mental conditions that, in the opinion of the Investigator, may confound the quantification of postoperative pain after herniorrhaphy.
- Has the ability and willingness to comply with the study procedures and the use of the pain scales.
- Is willing to use only permitted medications and anesthetics throughout the study.
Show all 9Show fewer
- Is willing to use opioid rescue analgesia for moderate to severe incisional pain only.
- Must voluntarily sign and date an informed consent form (ICF) that is approved by an Institutional Review Board (IRB) before the conduct of any study specific procedures.
- Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.
Who cannot join
- Has a known hypersensitivity to amide local anesthetics, opioids, bovine products or inactive ingredients of the test article.
- Is scheduled for bilateral inguinal herniorrhaphy.
- Has undergone a prior herniorrhaphy on the side that is currently scheduled for repair.
- Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
- Concomitantly uses antiarrhythmics (eg, amiodarone), propranolol or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).
- Has used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery
Show all 19Show fewer
- Has used aspirin or aspirin containing products within 7 days of surgery. Aspirin at a dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the patient has been on a stable dose regimen for ≥ 30 days before Screening.
- Has undergone major surgery within 3 months of the scheduled herniorrhaphy.
- Has known or suspected history of alcohol or drug abuse or misuse within 3 years of Screening or evidence of tolerance or physical dependency on opioid analgesics or sedative-hypnotic medications.
- Has used opioids or tramadol on an extended daily basis (> 7 days) before surgery. Patients who, in the Investigator's opinion, are developing opioid tolerance are to be excluded.
- Has impaired liver function, aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin ≥ 3.0 times the upper limit of normal (ULN), active hepatic disease, evidence of clinically significant liver disease or another condition (eg, alcoholism, cirrhosis or hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with exposure to test article.
- Has any clinically significant unstable cardiac, neurological, immunological, renal or hematological disease or any other condition that, in the opinion of the Investigator, could compromise the patient's welfare, ability to communicate with the study staff or otherwise contraindicate study participation.
- Is judged by the Investigator to be at risk for infection or slow wound healing.
- Has a chronic painful condition that might confound the assessment of pain associated with the herniorrhaphy.
- Routinely uses pain medication that, in the opinion of the Investigator, could confound the pain assessments during the study.
- Has been treated with agents that could affect the analgesic response (such as central alpha agents, neuroleptic agents and other antipsychotic agents) within 2 weeks of surgery.
- Has been treated with monoamine oxidase inhibitors (MAOIs) within 10 days of surgery.
- Has been treated with systemic corticosteroids within 7 days of surgery (inhaled and topical corticosteroids are allowed).
- Has participated in a clinical trial within 30 days of surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Clinical Research Institute
Anaheim, California, 92801
About this study
Official title: A Phase II, Randomized, Single Dose, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Pharmacokinetic Profile of the CollaRx® Bupivacaine Implant in Men After Open Mesh Herniorrhaphy
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after herniorrhaphy.
Read the detailed description
Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.
Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.
This study will compare the amount of narcotic pain medication required after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
- Conditions
- Postoperative Pain, Inguinal Hernia
- Being tested
- Bupivacaine Collagen Sponge, placebo collagen sponge
- Keywords
- Herniorrhaphy, Inguinal Hernia Repair, Postoperative pain
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Collagen SpongeDrug
Also called CollaRx Bupivacaine Implant
collagen; Bupivacaine hydrocholoride
placebo collagen spongeDrug
Also called Placebo
collagen
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Two, 5x5cm bupivacaine collagen sponges implanted during surgery Receives: Drug: Bupivacaine Collagen Sponge |
| 2 | Placebo comparator | Placebo collagen sponge implanted during surgery Receives: Drug: placebo collagen sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Use of Opioid Rescue Analgesia Over 0 to 24 Hours
Total Use of Opioid Rescue Analgesia (mg) Over 0 to 24 Hour - number count - higher score means worse outcome
Measured: 0 to 24 hours postoperatively
Secondary outcomes (9)
Total Use of Opioid Rescue Analgesia Over 0 to 48 Hours
Number count. Higher score means worse outcome
Measured: 0 to 48 hours postoperatively
Total Use of Opioid Rescue Analgesia Over 0 to 72 Hours
Number count - higher score means worse outcome
Measured: 0 to 72 hours postoperatively
Summed Pain Intensity VAS Scores (VAS at Rest and After Cough)
Summed pain intensity (SPI) (VAS at rest and after cough): - For the VAS assessment, patients measured their pain intensity at rest and after aggravated movement (cough) using a horizontal 100-mm VAS scale labeled as follows: No Pain (0 mm) as the left anchor and Worst Pain Imaginable (100 mm) as the right anchor. Each timepoint consist of two measurements (Resting \& Coughing) - The lower the score the better outcome for the patient. The highest total score (worst possible score) for the 10 timepoints would be 2000.
Measured: 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0
Patient's Global Evaluation of the Study Treatment on a 5 Point Likert Scale
For the 5-point categorical scale global evaluation of study treatment, the patient was instructed to score his global evaluation of the pain control provided by the study treatment where: 0 = poor, 1 = fair, 2 = good, 3 = very good and 4 = excellent
Measured: At 72 hours after time 0
VAS Pain Intensity Scores Over Time
For the VAS assessment, patients measured their pain intensity at rest and after aggravated movement (cough) using a horizontal 100-mm VAS scale labeled as follows: No Pain (0 mm) as the left anchor and Worst Pain Imaginable (100 mm) as the right anchor.
Measured: At 1, 1.5, 2,3,4,5,6,24,48,72 Hours
Categorical Pain Intensity Scores Over Time - AT REST
For the 4-point categorical scale assessment, patients measured their pain intensity at rest and after aggravated movement (cough) using a numerical scale where: 0 = "none," 1 = "mild," 2 = "moderate" and 3 = "severe."
Measured: At 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours
Categorical Pain Relief Scores Over Time - AT REST
For the 5-point categorical scale assessment of pain relief, the patient was instructed to score his pain relief using a numerical scale where: 0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief and 4 = complete relief.
Measured: At 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours
Categorical Pain Intensity Scores Over Time (After Cough)
For the 4-point categorical scale assessment, patients measured their pain intensity at rest and after aggravated movement (cough) using a numerical scale where: 0 = "none," 1 = "mild," 2 = "moderate" and 3 = "severe." Higher Score means a worse outcome
Measured: At 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours
Categorical Pain Relief Scores Over Time (After Cough)
For the 5-point categorical scale assessment of pain relief, the patient was instructed to score his pain relief using a numerical scale where: 0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief and 4 = complete relief.
Measured: At 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study start11 Mar 2008
- Primary completion29 Jan 2009
- Study completion29 Jan 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innocoll
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- David Prior, Study director, Innocoll
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626886
- Sponsor's protocol ID
- INN-CB-003
- Status last verified
- Jan 2021
- First submitted
- 20 Feb 2008
- Last updated
- 11 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cusack SL, Jaros M, Kuss M, Minkowitz HS, Winkle P, Hemsen L. Clinical evaluation of XaraColl((R)), a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies. J Pain Res. 2012;5:217-25. doi: 10.2147/JPR.S33453. Epub 2012 Jun 27.
PubMed 22792007
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Single Dose, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Pharmacokinetic Profile of the CollaRx® Bupivacaine Implant in Men After Open Mesh Herniorrhaphy
- ClinicalTrials.gov ID
- NCT00626886
- Acronym / sponsor ID
- INN-CB-003
- Conditions
- Postoperative Pain, Inguinal Hernia
- Keywords
- Herniorrhaphy, Inguinal Hernia Repair, Postoperative pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- InnocollIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 11 Mar 2008 (actual)
- Primary completion
- 29 Jan 2009 (actual)
- Study completion
- 29 Jan 2009 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Posted 11 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after herniorrhaphy.
Detailed description
Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.
Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.
This study will compare the amount of narcotic pain medication required after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bupivacaine Collagen SpongeTwo, 5x5cm bupivacaine collagen sponges implanted during surgery |
| 2 | Placebo comparator | Drug: placebo collagen spongePlacebo collagen sponge implanted during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has body mass index (BMI) > 19 and < 40 kg/m2.
- Has a planned unilateral inguinal herniorrhaphy (open mesh, tension free technique) to be performed according to standard surgical technique under general anesthesia.
- Has a risk classification of I, II or III according to the ASA.
- Is free of other physical or mental conditions that, in the opinion of the Investigator, may confound the quantification of postoperative pain after herniorrhaphy.
- Has the ability and willingness to comply with the study procedures and the use of the pain scales.
Key exclusion criteria (19 listed)
- Has a known hypersensitivity to amide local anesthetics, opioids, bovine products or inactive ingredients of the test article.
- Is scheduled for bilateral inguinal herniorrhaphy.
- Has undergone a prior herniorrhaphy on the side that is currently scheduled for repair.
- Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
- Concomitantly uses antiarrhythmics (eg, amiodarone), propranolol or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).
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 |
|---|---|---|
| Bupivacaine Collagen SpongeAlso: CollaRx Bupivacaine Implantcollagen; Bupivacaine hydrocholoride | Drug | 1 |
| placebo collagen spongeAlso: Placebocollagen | Drug | 2 |
Primary outcome
Total Use of Opioid Rescue Analgesia Over 0 to 24 Hours
Time frame: 0 to 24 hours postoperatively
Total Use of Opioid Rescue Analgesia (mg) Over 0 to 24 Hour - number count - higher score means worse outcome
9 secondary outcomes
Total Use of Opioid Rescue Analgesia Over 0 to 48 Hours
Time frame: 0 to 48 hours postoperatively
Total Use of Opioid Rescue Analgesia Over 0 to 72 Hours
Time frame: 0 to 72 hours postoperatively
Summed Pain Intensity VAS Scores (VAS at Rest and After Cough)
Time frame: 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0
Patient's Global Evaluation of the Study Treatment on a 5 Point Likert Scale
Time frame: At 72 hours after time 0
VAS Pain Intensity Scores Over Time
Time frame: At 1, 1.5, 2,3,4,5,6,24,48,72 Hours
Categorical Pain Intensity Scores Over Time - AT REST
Time frame: At 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours
Categorical Pain Relief Scores Over Time - AT REST
Time frame: At 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours
Categorical Pain Intensity Scores Over Time (After Cough)
Time frame: At 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours
Categorical Pain Relief Scores Over Time (After Cough)
Time frame: At 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22792007Cusack SL, Jaros M, Kuss M, Minkowitz HS, Winkle P, Hemsen L. Clinical evaluation of XaraColl((R)), a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies. J Pain Res. 2012;5:217-25. doi: 10.2147/JPR.S33453. Epub 2012 Jun 27.
- Clinical evaluation of a Bupivacaine-Collagen Implant (XaraColl®) for postoperative analgesia from two multicenter, randomized, double-blind, placebo-controlled pilot studiesLink provided by the sponsor.
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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.
David Prior study director
Innocoll
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine Collagen Sponge in people with Postoperative Pain and Inguinal Hernia, run by Innocoll at 1 site in United States.
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 9 inclusion and 19 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 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 11 Jan 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?
Total Use of Opioid Rescue Analgesia Over 0 to 24 Hours (time frame: 0 to 24 hours postoperatively). 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 NCT00626886, 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 11 Jan 2021.