Clinical trial NCT02299271: Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty
Official title: Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis of the Hip
Lead sponsor: The Christ Hospital
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Control
timeFrame: 24 hours
measure: Opioid Consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Post-Operative Care Unit (PACU) Length of Stay
timeFrame: From 60 minutes to 6 hours
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
Study officials:
affiliation: The Christ Hospital
name: Brian Vaughan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.