Pain, PostoperativePhase 3NCT04785625
Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty
A Phase 3 study testing Bupivacaine Hydrochloride in people with Pain, Postoperative and Abdominoplasty, run by Innocoll at 4 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty to evaluate postoperative analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative, Abdominoplasty
- What is being tested?
- Bupivacaine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Apr 2021to 27 Oct 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Has a body mass index of 18-35 kg/m2.
- Must qualify for a planned (nonemergency) abdominoplasty with rectus sheath plication, with an incision that does not extend beyond the umbilicus, to be performed using standard surgical technique under general anesthesia.
- Has the ability and willingness to comply with all study procedures including being domiciled for at least 72 hours after surgery.
- Is willing to use opioid analgesia, if needed.
Who cannot join
- Has a known hypersensitivity to amide-type local anesthetics, fentanyl, morphine, oxycodone, acetaminophen, NSAIDs, or bovine products.
- Is scheduled for other significant concurrent surgical procedures (eg, gastrointestinal resection or additional cosmetic procedures concurrent with abdominoplasty).
- Has used an opioid analgesic on an extended daily basis (≥5 mg oral morphine equivalents per day for 3 or more days a week) within 4 weeks before surgery and/or chronically uses pain medication.
- Has any chronic painful condition (eg, fibromyalgia), as determined by the investigator, that may confound the assessment of pain associated with the abdominoplasty procedure
Trial locations and contacts
4 sites in 1 country.
United States4 sites
HD Research
Bellaire, Texas, 77401
Midwest Clinical Research
Dayton, Ohio, 45417
Lotus Clinical Research
Pasadena, California, 91105
Endeavor Clinical Trials
San Antonio, Texas, 78229
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a 300-mg Dose of the INL-001 (Bupivacaine Hydrochloride) Implant in Patients Undergoing Abdominoplasty
This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty to evaluate postoperative analgesia.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty. Patients will undergo abdominoplasty and have INL-001 or placebo implanted intraoperatively.
The study includes a screening period, an inpatient period (preoperative, intraoperative, immediately postoperative) of approximately 4 days and an outpatient follow-up period (up to 30 days after treatment). Efficacy assessments will be made through 72 hours after treatment (after implant placement). Posttreatment safety assessments will be made throughout the study after the informed consent form is signed, and as specifically scheduled through 72 hours posttreatment, on day 7 (telephone), on day 15 (clinic visit), and on day 30 (clinic visit). Unless the investigator determines further hospitalization is necessary, the patient will be discharged on the day occurring 72 hours after surgery Inpatient day 4).
During the screening period, all patients will undergo eligibility and other screening and safety assessments. On the day of surgery, patient eligibility will be reconfirmed before the start of surgery, patients will be randomly assigned to treatment, and adverse events and prior/concomitant medications will be reviewed. Patients will undergo an abdominoplasty conducted under general anesthesia.
Adverse event and concomitant medication information, including use of rescue pain medication, will be collected throughout the study (inpatient and outpatient). Surgical wound healing/grading assessments and assessment for signs and symptoms potentially indicative of systemic bupivacaine toxicity will be made.
After surgery, patient reports of pain intensity using an 11-point numeric pain rating scale (NPRS) will be recorded at multiple time points through 72 hours posttreatment. Patients will be permitted rescue medication (oral and/or intravenous) to manage breakthrough pain when it occurs.
- Conditions
- Pain, Postoperative, Abdominoplasty
- Being tested
- Bupivacaine Hydrochloride, Placebo collagen-matrix implant
- Keywords
- Pain, Analgesia, Postoperative, Abdominoplasty, Bupivacaine, Implant, Postsurgical, Safety, Opioid, Tummy tuck, Efficacy, Post-operative, Post-surgical, Surgery, Placebo, Randomized, Double-blind, Phase 3, Nonopioid, Local anesthetic
- Medical subject headings
- Pain, Postoperative, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideCombination product
Also called XARACOLL (bupivacaine hydrochloride) Implant
INL-001 (bupivacaine hydrochloride) implant
Placebo collagen-matrix implantCombination product
Placebo collagen-matrix implant
| Study group | Role | What they receive |
|---|---|---|
| INL-001 (bupivacaine hydrochloride) implant | Experimental | INL-001 (bupivacaine hydrochloride) implant Receives: Combination Product: Bupivacaine Hydrochloride |
| Placebo implant | Placebo comparator | Placebo collagen-matrix implant Receives: Combination Product: Placebo collagen-matrix implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPI24
Sum of pain intensity (SPI).The time weighted sum of pain intensity from 0 to 24hours (ie, the area under the NRS PI curve from 0 to 24 hours). For the purpose of SPI computation, Pain Intensity at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation. Minimum value would be "0" and Maximum value would be 240. Time-weighted SPI is calculated as the sum of the pain intensities between successive time points (i.e., if SPI24 = ∑[PI x (time t - time t-1)], where "t" represents a given time point,"t-1" represents the previous time point, and time is expressed in hours). This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule.
Measured: 0 to 24 hours
Secondary outcomes (1)
The secondary objective is to assess the safety and tolerability of INL 001 implants after placement
Safety is assessed and measured by frequency and severity of adverse events
Measured: Day 1 through Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start29 Apr 2021
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innocoll
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Arriaga, Study director, Lotus Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785625
- Sponsor's protocol ID
- INN-CB-024
- Status last verified
- Nov 2022
- First submitted
- 1 Mar 2021
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beaton AC, Solanki D, Salazar H, Folkerth S, Singla N, Minkowitz HS, Leiman D, Vaughn B, Skuban N, Niebler G. A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty. Reg Anesth Pain Med. 2023 Dec;48(12):601-607. doi: 10.1136/rapm-2022-104110. Epub 2023 Apr 19.
PubMed 37076252
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a 300-mg Dose of the INL-001 (Bupivacaine Hydrochloride) Implant in Patients Undergoing Abdominoplasty
- ClinicalTrials.gov ID
- NCT04785625
- Acronym / sponsor ID
- INN-CB-024
- Conditions
- Pain, Postoperative, Abdominoplasty
- Keywords
- Pain, Analgesia, Postoperative, Abdominoplasty, Bupivacaine, Implant, Postsurgical, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- InnocollIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
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 multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty to evaluate postoperative analgesia.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty. Patients will undergo abdominoplasty and have INL-001 or placebo implanted intraoperatively.
The study includes a screening period, an inpatient period (preoperative, intraoperative, immediately postoperative) of approximately 4 days and an outpatient follow-up period (up to 30 days after treatment). Efficacy assessments will be made through 72 hours after treatment (after implant placement). Posttreatment safety assessments will be made throughout the study after the informed consent form is signed, and as specifically scheduled through 72 hours posttreatment, on day 7 (telephone), on day 15 (clinic visit), and on day 30 (clinic visit). Unless the investigator determines further hospitalization is necessary, the patient will be discharged on the day occurring 72 hours after surgery Inpatient day 4).
During the screening period, all patients will undergo eligibility and other screening and safety assessments. On the day of surgery, patient eligibility will be reconfirmed before the start of surgery, patients will be randomly assigned to treatment, and adverse events and prior/concomitant medications will be reviewed. Patients will undergo an abdominoplasty conducted under general anesthesia.
Adverse event and concomitant medication information, including use of rescue pain medication, will be collected throughout the study (inpatient and outpatient). Surgical wound healing/grading assessments and assessment for signs and symptoms potentially indicative of systemic bupivacaine toxicity will be made.
After surgery, patient reports of pain intensity using an 11-point numeric pain rating scale (NPRS) will be recorded at multiple time points through 72 hours posttreatment. Patients will be permitted rescue medication (oral and/or intravenous) to manage breakthrough pain when it occurs.
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 |
|---|---|---|
| INL-001 (bupivacaine hydrochloride) implant | Experimental | Combination Product: Bupivacaine HydrochlorideINL-001 (bupivacaine hydrochloride) implant |
| Placebo implant | Placebo comparator | Combination Product: Placebo collagen-matrix implantPlacebo collagen-matrix implant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has a body mass index of 18-35 kg/m2.
- Must qualify for a planned (nonemergency) abdominoplasty with rectus sheath plication, with an incision that does not extend beyond the umbilicus, to be performed using standard surgical technique under general anesthesia.
- Has the ability and willingness to comply with all study procedures including being domiciled for at least 72 hours after surgery.
- Is willing to use opioid analgesia, if needed.
Key exclusion criteria (4 listed)
- Has a known hypersensitivity to amide-type local anesthetics, fentanyl, morphine, oxycodone, acetaminophen, NSAIDs, or bovine products.
- Is scheduled for other significant concurrent surgical procedures (eg, gastrointestinal resection or additional cosmetic procedures concurrent with abdominoplasty).
- Has used an opioid analgesic on an extended daily basis (≥5 mg oral morphine equivalents per day for 3 or more days a week) within 4 weeks before surgery and/or chronically uses pain medication.
- Has any chronic painful condition (eg, fibromyalgia), as determined by the investigator, that may confound the assessment of pain associated with the abdominoplasty procedure
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 HydrochlorideAlso: XARACOLL (bupivacaine hydrochloride) ImplantINL-001 (bupivacaine hydrochloride) implant | Combination product | INL-001 (bupivacaine hydrochloride) implant |
| Placebo collagen-matrix implantPlacebo collagen-matrix implant | Combination product | Placebo implant |
Primary outcome
SPI24
Time frame: 0 to 24 hours
Sum of pain intensity (SPI).The time weighted sum of pain intensity from 0 to 24hours (ie, the area under the NRS PI curve from 0 to 24 hours). For the purpose of SPI computation, Pain Intensity at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation. Minimum value would be "0" and Maximum value would be 240. Time-weighted SPI is calculated as the sum of the pain intensities between successive time points (i.e., if SPI24 = ∑[PI x (time t - time t-1)], where "t" represents a given time point,"t-1" represents the previous time point, and time is expressed in hours). This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule.
1 secondary outcome
The secondary objective is to assess the safety and tolerability of INL 001 implants after placement
Time frame: Day 1 through Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Derived from this study: PubMed 37076252Beaton AC, Solanki D, Salazar H, Folkerth S, Singla N, Minkowitz HS, Leiman D, Vaughn B, Skuban N, Niebler G. A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty. Reg Anesth Pain Med. 2023 Dec;48(12):601-607. doi: 10.1136/rapm-2022-104110. Epub 2023 Apr 19.
- Individual participant dataSharing planned: No
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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.
Anne Arriaga study director
Lotus Clinical Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine Hydrochloride in people with Pain, Postoperative and Abdominoplasty, run by Innocoll at 4 sites 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 4 inclusion and 4 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 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SPI24 (time frame: 0 to 24 hours). 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 NCT04785625, 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 21 Nov 2022.