Clinical trial NCT04785625: Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Abdominoplasty
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
Lead sponsor: Innocoll
Sponsor class: INDUSTRY
First posted: 2021-03-08
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: SPI24
timeFrame: 0 to 24 hours
Secondary outcomes:
measure: The secondary objective is to assess the safety and tolerability of INL 001 implants after placement
timeFrame: Day 1 through Day 30
Other outcomes:
measure: SPI48
timeFrame: 0 to 48 hours
measure: SPI72
timeFrame: 0 to 72 hours
measure: Proportion of patients who are opioid free through 24 hours
timeFrame: Time 0 through 24 hours
measure: Proportion of patients who are opioid free through 48 hours
timeFrame: Time 0 through 48 hours
measure: Proportion of patients who are opioid free through 72 hours
timeFrame: Time 0 through 72 hours
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
city: Dayton
country: United States
facility: Midwest Clinical Research
state: Ohio
city: Bellaire
country: United States
facility: HD Research
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
Study officials:
affiliation: Lotus Clinical Research
name: Anne Arriaga
role: STUDY_DIRECTOR
References: