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

The Christ Hospital

Status and phase: Terminated; Phase 4

Conditions: Osteoarthritis of the Hip

Treatments: Drug: Ropivacaine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02299271

Christh-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

72 participants in 2 patient groups, including a placebo group

ropivacaine block

Active Comparator group

Description:

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

Treatment:

Drug: Ropivacaine

saline block

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline