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

NCT ID: NCT03001453

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-03-31

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.

Detailed Description

All surgeries were performed by the same orthopaedic surgeon. Two groups, one receiving Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine (LB group) and the other receiving bupivacaine with epinephrine (Control group), will be compared using post-operative pain scores, hospital length of stay, time to ambulation, falls, narcotic use, and narcotic-related adverse effects. Aside from hospital length of stay, all outcomes were recorded for up to 72 hours following surgery. An a priori power analysis was performed to calculate the total number of patients that needed to be enrolled to achieve a minimum 90% power, with the threshold of statistical significance set to 0.05. Based on a previous study reporting a mean oral opioid consumption of 57.04mg ± 25.6 at 24 hours post THR, a mean difference of 17.14mg was considered to be clinically significant. Thus, at least 26 patients were necessary in each group for an adequately powered assessment. The diagnosis for osteoarthritis was determined by patient history, physical examination, and imaging findings. Each patient received a thorough explanation of the protocol, and willing patients signed an informed consent form. All patients underwent a personal preoperative education program regarding pre, intra-, and post-procedural information including physical therapy, expectations, discharge goals, home therapy, and pain management. After written consent was collected, the form was sent to the hospital pharmacy for randomization. Envelopes were randomized, sealed, numbered, and given to the pharmacy staff, ultimately dispensing the envelopes to the nurse in the operating room in numerical order. The pharmacy documented the required information, selected medication, and drug accountability forms according to the contents of the envelopes.

A nurse delivered study drugs to the operating room in a sealed, non-descriptive envelope. During the standard anterior approach procedure, an anesthesiologist administered fentanyl or hydromorphone as needed for analgesia. The local anesthetics were administered after reduction of the implants. Patients in the LB group received 20cc liposomal bupivacaine, 40cc 0.25% bupivacaine with epinephrine, and 20cc of normal saline. Each patient in the control group received 60cc of 0.25% bupivacaine with epinephrine. Using a 20-gauge spinal needle, the local anesthetics were injected using a deep tissue administration technique. Structures innervated by the femoral nerve, superior gluteal nerve, or lateral femoral cutaneous nerve were considered suitable for injection. Throughout administration, frequent aspirations were performed to check for blood and minimize the risk of intravascular injection. The patients, surgical team, and floor staff was blinded to the local anesthetic drugs given.

During hospitalization, patients were observed, evaluated and treated according to postoperative protocols. Patients received opioids for pain management as needed, which was routinely documented by hospital staff. Opioids included fentanyl, hydromorphone, oxycodone, codeine, tramadol, morphine, and hydrocodone. All opioid dosages were converted into morphine equivalent dosages for analysis. Each patient began physical therapy within the first 24 hours postoperatively. Patients were discharged when they were able to begin self-care, their pain was controlled utilizing an oral regimen, and they were able to tolerate oral medication intake.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Liposomal bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Saline

Intervention Type: DRUG

Normal saline

Liposomal Bupivacaine

Intervention Type: DRUG

266mg liposomal bupivacaine

0.25% Bupivacaine with epinephrine

Intervention Type: DRUG

0.25% bupivacaine with epinephrine

Bupivacaine with epinephrine

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

Group Type: ACTIVE_COMPARATOR

0.25% Bupivacaine with epinephrine

Intervention Type: DRUG

0.25% bupivacaine with epinephrine

Interventions

Saline

Normal saline

Intervention Type: DRUG

Liposomal Bupivacaine

266mg liposomal bupivacaine

Intervention Type: DRUG

0.25% Bupivacaine with epinephrine

0.25% bupivacaine with epinephrine

Intervention Type: DRUG

Other Intervention Names

Exparel; Marcaine; Saline solution

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Hip Institute

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Domb

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin G Domb, MD

Role: PRINCIPAL_INVESTIGATOR

American Hip Institute

Locations

Adventist Hinsdale Hospital

Hinsdale, Illinois, United States

American Hip Institute

Westmont, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29033152 (View on PubMed)

Other Identifiers

AHI-001

Identifier Type: -

Identifier Source: org_study_id