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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04785625
• Other study ID #: INN-CB-024
• Status: Completed
• Phase: Phase 3
• Start date: April 29, 2021
• Est. completion date: October 27, 2021

Study information

• Verified date: November 2022
• Source: Innocoll
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominoplasty
• Pain, Postoperative

Intervention

Combination Product:
• Bupivacaine Hydrochloride
INL-001 (bupivacaine hydrochloride) implant
• Placebo collagen-matrix implant
Placebo collagen-matrix implant

Locations

Country	Name	City	State
United States	HD Research	Bellaire	Texas
United States	Midwest Clinical Research	Dayton	Ohio
United States	Lotus Clinical Research	Pasadena	California
United States	Endeavor Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Innocoll

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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