Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Abdominoplasty
• Intervention / Treatment: Combination product: Bupivacaine Hydrochloride; Combination product: Placebo collagen-matrix implant

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 Type: Interventional
• Enrollment (Actual): 366
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research
  • Texas
    • Bellaire, Texas, United States, 77401
      • HD Research
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INL-001 (bupivacaine hydrochloride) implant	Combination product: Bupivacaine Hydrochloride; INL-001 (bupivacaine hydrochloride) implant; Other Names: XARACOLL (bupivacaine hydrochloride) Implant
Placebo Comparator: Placebo implant; Placebo collagen-matrix implant	Combination product: Placebo collagen-matrix implant; Placebo collagen-matrix implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1 through Day 30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPI48	Sum of pain intensity (SPI).The time weighted sum of pain intensity from 0 to 48 hours (ie, the area under the NRS PI curve from 0 to 48 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 480. 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.	0 to 48 hours
SPI72	Sum of pain intensity (SPI). The time weighted sum of pain intensity from 0 to 72 hours (ie, the area under the NRS PI curve from 0 to 72 hours). For the purpose of SPI computation, PI at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation. Where 0 indicates "no pain" and 10 indicated "worst pain possible". A lower score is a better outcome. Minimum value would be "0" and Maximum value would be 720. Time-weighted SPI is calculated as the sum of the pain intensities between successive time points (i.e., if SPI72 = ∑[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.	0 to 72 hours
Proportion of patients who are opioid free through 24 hours	Proportion of patients who are opioid free through 24 hours	Time 0 through 24 hours
Proportion of patients who are opioid free through 48 hours	Proportion of patients who are opioid free through 48 hours	Time 0 through 48 hours
Proportion of patients who are opioid free through 72 hours	Proportion of patients who are opioid free through 72 hours	Time 0 through 72 hours

Collaborators and Investigators

• Sponsor: Innocoll

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Actual): October 27, 2021
• Study Completion (Actual): October 27, 2021

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Pain; Surgery; Efficacy; Analgesia; Opioid; Randomized; Double-blind; Local anesthetic; Post-operative; Bupivacaine; Post-surgical; Postoperative; Phase 3; Placebo; Implant; Abdominoplasty; Postsurgical; Tummy tuck; Nonopioid
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: INN-CB-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No