Intraoperative Liposomal Bupivacaine vs. Bupivacaine for Total Hip Replacement Pain Management

NCT03001453 | Completed Phase 2 Results

• 1 other identifier: AHI-001
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare two medications currently injected intra-operatively to help decrease pain after surgery in patients undergoing a primary total hip replacement (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to see if one medication works better than the other in managing post-operative pain after THR. The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate better pain management in THR patients post-operatively. Both medications are FDA-approved for post-operative analgesia.

Conditions

Pain, Postoperative

Keywords

Exparel; total hip replacement; bupivacaine

Outcome Measures

Primary Outcomes (5)

• Patient Morphine Equivalent Consumption

  All opioid doses were administered to the patient at 12-hour intervals post-surgery. Doses were recorded till either of the following criteria was met, the patient was discharged or the 72-hour post-surgery timeframe ended. The doses were then collected and converted to OMEs, in milligrams.

  72 hours postoperation, divided into six 12-hour periods

• Change in Patient-reported Visual Analog Scale (VAS) Pain Intensity Score

  Patient-reported VAS pain intensity score (0 = no pain, 10 = worst pain possible) will be collected. Mean VAS scores for the 72-hour period were calculated using the cohort's reported average pain scores at each 12-hour interval.

  72 hours post-operation, divided into six 12-hour periods

• Time to Ambulation More Than 20 Feet (in Hours)

  The length of time (in hours) until the patient first ambulates more than 20 feet from the time of surgery will be recorded.

  from time of surgery until patient first ambulates more than 20 feet or 72 hours post-surgery or patient discharge, whichever comes first

• Length of Stay (LOS, in Days)

  From time of surgery until patient is discharged, an average of 1.5 days.

• Number of Patients That Experienced a Fall

  72 hours postoperation

Study Arms (2)

Liposomal bupivacaine

ACTIVE COMPARATOR

Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine

Drug: Liposomal Bupivacaine; Drug: 0.25% Bupivacaine with epinephrine; Drug: Saline

Bupivacaine with epinephrine

ACTIVE COMPARATOR

Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine

Drug: 0.25% Bupivacaine with epinephrine

Interventions

Liposomal Bupivacaine DRUG

266mg liposomal bupivacaine

Also known as: Exparel

Liposomal bupivacaine

0.25% Bupivacaine with epinephrine DRUG

0.25% bupivacaine with epinephrine

Also known as: Marcaine

Bupivacaine with epinephrine; Liposomal bupivacaine

Saline DRUG

Normal saline

Also known as: Saline solution

Liposomal bupivacaine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo primary unilateral total hip replacement
• Patients diagnosed with hip osteoarthritis
• Patients failed to improve with conservative measures
• Patients willing and able to sign informed consent

You may not qualify if:

• Revision total hip replacement
• Bilateral total hip replacement
• Birmingham hip resurfacing
• Patients with hepatic/kidney disease
• Patients with a known allergy to bupivacaine or other local anesthetics

Sponsors & Collaborators

• American Hip Institute: lead

Study Sites (2)

Adventist Hinsdale Hospital

Hinsdale, Illinois, 60521, United States

Location

American Hip Institute

Westmont, Illinois, 60559, United States

Location

Related Publications (1)

• Perets I, Walsh JP, Mu BH, Yuen LC, Ashberg L, Battaglia MR, Domb BG. Intraoperative Infiltration of Liposomal Bupivacaine vs Bupivacaine Hydrochloride for Pain Management in Primary Total Hip Arthroplasty: A Prospective Randomized Trial. J Arthroplasty. 2018 Feb;33(2):441-446. doi: 10.1016/j.arth.2017.09.013. Epub 2017 Sep 20.

  PMID: 29033152 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Epinephrine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Benjamin Domb
• Organization: American Hip Institute

drdomb@americanhipinstitute.org

630-455-7130

Study Officials

• Benjamin G Domb, MD

  American Hip Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: December 23, 2016
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 26, 2018
• Results First Posted: July 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)