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

Osteoarthritis of the Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02299271
• Other study ID #: Christh-01
• Status: Terminated
• Phase: Phase 4
• First received: November 19, 2014
• Last updated: February 7, 2017
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: The Christ Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Hip
• Osteoarthritis, Hip
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine
0.375% ropivacaine as a one-time, 60 milliliter injection
• Saline
Saline as a one-time, 60 milliliter injection.

Locations

Country	Name	City	State
United States	The Christ Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Christ Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Control	Measured by NRS-11 beginning in post-operative care unit and continuing 24 hours on the post-operative floor.	24 hours
Primary	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	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