Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-12-31

Brief Summary

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This study evaluates post-operative pain management and narcotic consumption in patients receiving a fascia iliaca block with local anesthetic versus patients receiving fascia iliaca block with saline for total hip arthroplasty.

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Detailed Description

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Although many improvements have been made in implant technology and surgical approaches for total hip arthroplasty, management of post-operative pain remains a major clinical issue. Inadequate pain control can lead to numerous unwanted side effects and limited physical function, especially in a older population. Most surgeons have adopted a multi-modality pain management approach using a variety of pharmaceuticals, including nerve block with local anesthetic. In the literature, there are a number of technical variations described for the fascia iliaca nerve block. At The Christ Hospital, Cincinnati, Ohio, anesthesiologists use a more proximal approach to the fasica iliaca block enabling a significantly easier cephalad spread of the local anesthetic into the pelvis targeting all three nerves; the femoral, lateral femoral cutaneous, and the obturator.

This prospective, double-blinded, randomized, single-center study is designed to test the primary hypothesis that fascia iliaca block with a local anesthestic decreases narcotic consumption and provides improved pain control compared to placebo in the first 24 hours after surgery in patients undergoing total hip arthroplasty.

Conditions

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Osteoarthritis of the Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ropivacaine block

Ropivacaine 0.375% as a one-time 60 milliliter injection.

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

0.375% ropivacaine as a one-time, 60 milliliter injection

saline block

Sodium chloride 0.9% as a one-time 60 milliliter injection.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Saline as a one-time, 60 milliliter injection.

Interventions

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Ropivacaine

0.375% ropivacaine as a one-time, 60 milliliter injection

Intervention Type DRUG

Saline

Saline as a one-time, 60 milliliter injection.

Intervention Type DRUG

Other Intervention Names

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Naropin Sodium Chloride 0.9%

Eligibility Criteria

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Inclusion Criteria

* anterior approach total hip arthroplasty (THA) for unilateral osteoarthritis
* English-speaking
* age 18 to 75 years
* American Society of Anesthesiologists (ASA) physical status 1 to 3
* BMI \< 40 kg/m2
* Minimum weight of 50 kg.
* No contraindications to study procedures

Exclusion Criteria

* Hip revision surgery
* Allergy to local anesthetics
* Allergy to oxycontin
* Allergy to pregabalin
* Allergy to fentanyl
* Allergy to midazolam
* Allergy to hydromorphone
* BMI \> 40 kg/m2
* Chronic pre-operative opioid use

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No