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

Phase 4

Terminated

• Conditions: Osteoarthritis of the Hip
• Interventions: Drug: Ropivacaine; Drug: Saline

• Registration Number: NCT02299271
• Lead Sponsor: The Christ Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine block	Ropivacaine	Ropivacaine 0.375% as a one-time 60 milliliter injection.
saline block	Saline	Sodium chloride 0.9% as a one-time 60 milliliter injection.

Primary Outcome Measures

Name	Time	Method
Opioid Consumption	24 hours	Measured by IV narcotic consumption beginning in the post-operative care unit and continuing 24 hours on the post-operative floor.
Pain Control	24 hours	Measured by NRS-11 beginning in post-operative care unit and continuing 24 hours on the post-operative floor.

Secondary Outcome Measures

Name	Time	Method
Post-Operative Care Unit (PACU) Length of Stay	From 60 minutes to 6 hours	Length of PACU stay is measured from arrival in PACU to clinical discharge from PACU

Trial Locations

Locations (1)

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States