Exparel vs. Bupivacaine Hydrochloride vs. Placebo for Hernia Repair

NCT03541941 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 18-133
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Patients usually experience some level of pain after their hernia repair. To control pain after the operation, surgeons have many options. One of them is to make some injections of pain blocker medications into the nerves that are responsible for the sensations the abdominal wall.This procedure is called TAP block (transversus abdominis place block). These medications are called local anesthetics, and there is a variety of medications that can be used. One of such medications is called Exparel® (Liposomal Bupivacaine). Exparel® has the potential benefit of lasting more hours than regular anesthetics. Although this drug is being used with increasing frequency, the investigators do not have good quality studies investigating the benefits of using this medication during a hernia repair, especially when compared to other types of local anesthetics (Bupivacaine Hydrochloride) or when compared to not injecting this medication at all. This study aim to investigate if Exparel®, when injected in the nerves of the abdominal wall during hernia repair can: (1) reduce the dose of additional opioid medications (morphine and similar) needed to achieve good pain control and (2) result in lower pain scores. The hypothesis is that Exparel® will result in a 30% decrease in the total requirements for opioid medications during the first 72 hours after surgery. Patients will be randomized to receive either Exparel®+Bupivacaine Hydrochloride, Bupivacaine Hydrochloride or Placebo (normal saline) during the operation through a TAP block. All patients will receive a patient controlled analgesia device after the operation, where patients can simply push a button every time they feel pain and the device will administer a dose of opioid medications. The investigators of the study will record the necessary amount of opioids used by the patients to achieve good pain control and also record pain scores several times during hospital stay.

Conditions

Analgesia, Postoperative

Keywords

Liposomal Bupivacaine; Exparel; Transversus Abdominis Plane block; Hernia

Outcome Measures

Primary Outcomes (5)

• Cumulative Opioid Requirements for 72 Hours After Surgery

  Measured in milligrams or micrograms as appropriate and converted to oral morphine equivalent daily dose. The cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparations will be recorded. Such assessment will be performed at the 3rd postoperative day (72 hours of operation).

  Measured from end of surgery until 72 hours after the surgery

• Cumulative Opioid Requirements at Postoperative Day 0

  Measured in milligrams or micrograms as appropriate and converted to oral morphine equivalent daily dose. The cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparation will be measured at postoperative day 0 (day of surgery).

  From end of surgery until the end of postoperative day 0 (23:59pm of postoperative day 0)

• Cumulative Opioid Requirements at Postoperative Day 1

  Measured in milligrams or micrograms as appropriate and converted to oral morphine equivalent daily dose. Cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparations, measured at postoperative day 1

  From 00:00am of postoperative day 1 until (23:59pm of postoperative day 1)

• Cumulative Opioid Requirements at Postoperative Day 2

  Measured in milligrams or micrograms as appropriate and converted to oral morphine equivalent daily dose. Cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparations, measured at postoperative day 2

  From 00:00 of postoperative day 2 until 23:59pm of postoperative day 2

• Cumulative Opioid Requirements at Postoperative Day 3

  Measured in milligrams or micrograms as appropriate and converted to oral morphine equivalent daily dose. Cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparations, measured at postoperative day 3

  From 00:00 of postoperative day 3 until 23:59pm of postoperative day 3

Secondary Outcomes (8)

• Opioid Requirements for Total Length of Hospital Stay

  Measured from end of surgery until the time of hospital discharge, up to a maximum of 6 days

• Pain Scores at Postoperative Day 0

  Measured once, from end of surgery until the end of postoperative day 0 (23:59pm of the day of surgery)

• Pain Scores at Postoperative Day 1

  Measured once, from 00:00am of postoperative day 1 until the end of postoperative day 1 (23:59pm of postoperative day 1)

• Pain Scores at Postoperative Day 2

  Measured once, from 00:00am of postoperative day 2 until the end of postoperative day 2 (23:59pm of postoperative day 2)

• Pain Scores at Postoperative Day 3

  Measured once, from 00:00am of postoperative day 3 until the end of postoperative day 3 (23:59pm of postoperative day 3)

Study Arms (3)

Exparel

EXPERIMENTAL

Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization

Drug: Exparel; Drug: Bupivacaine Hcl 0.25% Inj

Bupivacaine Hcl 0.25% Inj

ACTIVE COMPARATOR

Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization

Drug: Bupivacaine Hcl 0.25% Inj

Placebo

PLACEBO COMPARATOR

120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization

Drug: Placebo

Interventions

Exparel DRUG

Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block

Exparel

Bupivacaine Hcl 0.25% Inj DRUG

Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block

Bupivacaine Hcl 0.25% Inj; Exparel

Placebo DRUG

Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients with Primary Ventral or Incisional Hernias
• Scheduled to undergo hernia repair through an open approach
• Hernia repair performed in an elective setting
• Hernia repair performed through a midline incision
• Hernia repair performed in a clean wound
• Hernia repair performed with mesh placed in the retromuscular position

You may not qualify if:

• patients with less than 18 years old of age
• patients scheduled to undergo a minimally invasive hernia repair
• patients where hernia repair is planned to be performed with mesh placement in a different position than retromuscular
• patient undergoing hernia repair with a clean-contaminated, contaminated or infected wound
• patients undergoing hernia repair in an non-elective fashion
• patients with allergy, hypersensitivity or contraindication to bupivacaine
• patients with history of chronic liver disease with moderate or severe impairment in liver function defined as a Child-Pugh class B or C
• patients with chronic kidney disease on dialysis
• chronic opioid users, defined as daily or near daily use of opioids for at least 90 days in the past year
• patients unable to provide informed written consent

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Cleveland Clinic Comprehensive Hernia Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Fafaj A, Krpata DM, Petro CC, Prabhu AS, Rosenblatt S, Tastaldi L, Alkhatib H, Tu C, Zolin SJ, Thomas JD, Costanzo AM, Rosen MJ. The Efficacy of Liposomal Bupivacaine on Postoperative Pain Following Abdominal Wall Reconstruction: A Randomized, Double-blind, Placebo-controlled Trial. Ann Surg. 2022 Aug 1;276(2):224-232. doi: 10.1097/SLA.0000000000004424. Epub 2020 Dec 2.

  PMID: 33273351 DERIVED

MeSH Terms

Conditions

Agnosia; Hernia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Michael Rosen
• Organization: Cleveland Clinic Foundation

rosenm@ccf.org

216-445-3441

Study Officials

• Michael J. Rosen, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 31, 2018
• Study Start: July 3, 2018
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)