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

NCT02299271 | Terminated Phase 4 DMC

• 1 other identifier: Christh-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of the Hip

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Post-Operative Care Unit (PACU) Length of Stay

  From 60 minutes to 6 hours

Study Arms (2)

ropivacaine block

ACTIVE COMPARATOR

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

Drug: Ropivacaine

saline block

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Ropivacaine DRUG

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

Also known as: Naropin

ropivacaine block

Saline DRUG

Saline as a one-time, 60 milliliter injection.

Also known as: Sodium Chloride 0.9%

saline block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Christ Hospital: lead

Study Sites (1)

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Related Publications (1)

• 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.

  PMID: 23558369 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Brian Vaughan, MD

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Brian Vaughan, MD

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 24, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

US (1)