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

Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis of the Hip
• Intervention / Treatment: Drug: Ropivacaine; Drug: Saline

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ropivacaine block; Ropivacaine 0.375% as a one-time 60 milliliter injection.	Drug: Ropivacaine; 0.375% ropivacaine as a one-time, 60 milliliter injection; Other Names: Naropin
Placebo Comparator: saline block; Sodium chloride 0.9% as a one-time 60 milliliter injection.	Drug: Saline; Saline as a one-time, 60 milliliter injection.; Other Names: Sodium Chloride 0.9%

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Christ Hospital
• Investigators: Principal Investigator: Brian Vaughan, MD, The Christ Hospital

Publications and helpful links

General Publications

• Shariat AN, Hadzic A, Xu D, Shastri U, Kwofie K, Gandhi K, McCally CM, Gratenstein K, Vandepitte C, Gadsden J, Unis D. Fascia lliaca block for analgesia after hip arthroplasty: a randomized double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2013 May-Jun;38(3):201-5. doi: 10.1097/AAP.0b013e31828a3c7c.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 19, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Pain, Postoperative; Osteoarthritis, Hip; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: Christh-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No