Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures

NCT02679560 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 782382D6.715L15J91110
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigator-initiated, single-center, randomized, patient blinded, controlled trial. The purpose of this study is to compare the effect of a fascia iliaca compartment block (FICB) using 0.2% ropivacaine vs. liposomal bupivacaine in patients with femur and/or hip fractures admitted to the University of California Davis Medical Center (UCDMC). The primary endpoint will be the total opioid requirements during the 96 hour randomization period with secondary endpoints including total daily opioid requirements for days 1-4, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay.

Conditions

Femoral Fractures

Keywords

femur fracture, hip fracture, exparel, liposomal bupivacaine

Outcome Measures

Primary Outcomes (1)

• Opioid Requirements

  Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents

  Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale.

Secondary Outcomes (1)

• Patient Outcomes

  Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale.

Study Arms (2)

Liposomal Bupivacaine

ACTIVE COMPARATOR

In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered

Drug: Liposomal Bupivacaine

Ropivacaine HCL

PLACEBO COMPARATOR

In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered

Drug: Ropivacaine HCL

Interventions

Liposomal Bupivacaine DRUG

A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine

Also known as: Exparel®

Liposomal Bupivacaine

Ropivacaine HCL DRUG

Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally.

Also known as: Naropin (trade name)

Ropivacaine HCL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years ≤ 70 years
• Patient's s/p trauma, with confirmed femur and/or hip fractures with a planned admission to the hospital
• Patient is ambulatory without assistance (e.g. walker, cane, caretaker) prior to incident.

You may not qualify if:

• \>10 hours since presentation to the emergency department
• History of seizure disorder, recent seizure or a document intra-cranial hemorrhage.
• Central or peripheral neurologic deficit on presentation
• Concern or compartment syndrome
• Associated additional long bone fractures
• End stage liver failure
• Renal failure requiring dialysis
• Pregnancy or breast feeding
• Prisoners
• Coagulopathy with INR \>1.5
• Use of direct thrombin inhibitors (bivalirudin, argatroban, desirudin, dabigatran etexilate), or direct factor Xa inhibitors (rivaroxaban, apixaban, edoxaban)
• Suspected prolonged intubation within first 12 hours secondary to respiratory failure other than peri-procedurally
• Adults unable to consent
• Pediatric patients \<18 years old
• Patients exhibiting signs of shock upon admission, HR \>120 or SBP \<100 mmHg.

Sponsors & Collaborators

• Ian Elliott Brown: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of California Davis Med Center- Trauma and Acute Care Surgery

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Femoral Fractures; Hip Fractures

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

There was a lack of enrollment and the sample size was too small to draw any results or conclusions for the study.

Results Point of Contact

• Title: Dr. Ian Brown
• Organization: UC Davis

iebrown@ucdavis.edu

(916)734-1279

Study Officials

• Ian Brown, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 10, 2016
• Study Start: October 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)