Extended Delivery of Bupivacaine Study in Herniorrhaphy

Analgesia Clinical Trial

Official title:

A Randomized, Phase 4 Study of the Efficacy, Safety, and Pharmacokinetics of Bupivacaine Administered as Liposomal Bupivacaine or Continuous Infusion Via Elastomeric Pump Following Unilateral Open Inguinal Herniorrhaphy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102267
• Other study ID #: BUPI-501
• Status: Completed
• Phase: Phase 4
• Start date: July 2, 2018
• Est. completion date: October 26, 2018

Study information

• Verified date: September 2019
• Source: Heron Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 26, 2018
• Est. primary completion date: September 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives

• Has undergone 3 or more surgeries within 12 months

• Has a body mass index (BMI) >39 kg/m2.

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Bupivacaine liposome injectable suspension
Liposomal bupivacaine 266 mg via injection
• Bupivacaine HCl without epinephrine via continuous infusion
Bupivacaine HCl 300 mg via continuous infusion

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Heron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total postoperative opioid consumption (in morphine equivalents)		72 hours
Secondary	Proportion of subjects who are opioid-free		72 hours
Secondary	Median time in hours to first opioid rescue medication		72 hours
Secondary	Mean AUC0-72 of the NRS-R pain intensity scores.		72 hours