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

NCT ID: NCT04785625

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2021-10-27

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

INL-001 (bupivacaine hydrochloride) implant

INL-001 (bupivacaine hydrochloride) implant

Group Type: EXPERIMENTAL

Bupivacaine Hydrochloride

Intervention Type: COMBINATION_PRODUCT

INL-001 (bupivacaine hydrochloride) implant

Placebo implant

Placebo collagen-matrix implant

Group Type: PLACEBO_COMPARATOR

Placebo collagen-matrix implant

Intervention Type: COMBINATION_PRODUCT

Placebo collagen-matrix implant

Interventions

Bupivacaine Hydrochloride

INL-001 (bupivacaine hydrochloride) implant

Intervention Type: COMBINATION_PRODUCT

Placebo collagen-matrix implant

Placebo collagen-matrix implant

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

XARACOLL (bupivacaine hydrochloride) Implant

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innocoll

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Arriaga

Role: STUDY_DIRECTOR

Lotus Clinical Research

Locations

Lotus Clinical Research

Pasadena, California, United States

Midwest Clinical Research

Dayton, Ohio, United States

HD Research

Bellaire, Texas, United States

Endeavor Clinical Trials

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37076252 (View on PubMed)

Other Identifiers

INN-CB-024

Identifier Type: -

Identifier Source: org_study_id