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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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02299271
Enrollment
72
Registered
2014-11-24
Start date
2014-06-30
Completion date
2016-12-31
Last updated
2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Hip

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.

Interventions

DRUGRopivacaine

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

DRUGSaline

Saline as a one-time, 60 milliliter injection.

Sponsors

The Christ Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Control24 hoursMeasured by NRS-11 beginning in post-operative care unit and continuing 24 hours on the post-operative floor.
Opioid Consumption24 hoursMeasured by IV narcotic consumption beginning in the post-operative care unit and continuing 24 hours on the post-operative floor.

Secondary

MeasureTime frameDescription
Post-Operative Care Unit (PACU) Length of StayFrom 60 minutes to 6 hoursLength of PACU stay is measured from arrival in PACU to clinical discharge from PACU

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026