Extended Delivery of Bupivacaine Study in Herniorrhaphy

NCT04102267 | Completed Phase 4 FDA Drug

• 1 other identifier: BUPI-501
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal herniorrhaphy.

Conditions

Analgesia

Keywords

herniorrhaphy; inguinal hernia; hernia; hernia surgery; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) through 72 hours (AUC0-72)

  72 hours

Secondary Outcomes (4)

• Total postoperative opioid consumption (in morphine equivalents)

  72 hours

• Proportion of subjects who are opioid-free

  72 hours

• Median time in hours to first opioid rescue medication

  72 hours

• Mean AUC0-72 of the NRS-R pain intensity scores.

  72 hours

Study Arms (2)

Liposomal bupivacaine injection (Group 1)

EXPERIMENTAL

Liposomal bupivacaine 266 mg via injection

Drug: Bupivacaine liposome injectable suspension

Bupivacaine HCl continuous infusion (Group 2)

EXPERIMENTAL

Bupivacaine HCl 300 mg via continuous infusion

Drug: Bupivacaine HCl without epinephrine via continuous infusion

Interventions

Bupivacaine liposome injectable suspension DRUG

Liposomal bupivacaine 266 mg via injection

Liposomal bupivacaine injection (Group 1)

Bupivacaine HCl without epinephrine via continuous infusion DRUG

Bupivacaine HCl 300 mg via continuous infusion

Bupivacaine HCl continuous infusion (Group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia
• Has an American Society of Anesthesiologists Physical Status of I, II, or III
• Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile,or using acceptable contraceptives.

You may not qualify if:

• Had any prior inguinal hernia repair
• Has a planned concurrent surgical procedure
• Has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain
• Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications
• Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
• Has taken any NSAIDs within least 10 days prior to the scheduled surgery
• Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting)
• Has been administered bupivacaine within 5 days prior to the scheduled surgery.
• Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.
• Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug
• Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments
• Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C
• Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments
• Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
• Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study.

Sponsors & Collaborators

• Heron Therapeutics: lead

Study Sites (1)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

MeSH Terms

Conditions

Agnosia; Hernia, Inguinal; Hernia; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal; Pathological Conditions, Anatomical; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: July 2, 2018
• Primary Completion: September 3, 2018
• Study Completion: October 26, 2018
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

US (1)