Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty
Primary Purpose
Osteoarthritis of the Hip
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Hip
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
Sites / Locations
- The Christ Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ropivacaine block
saline block
Arm Description
Ropivacaine 0.375% as a one-time 60 milliliter injection.
Sodium chloride 0.9% as a one-time 60 milliliter injection.
Outcomes
Primary Outcome Measures
Pain Control
Measured by NRS-11 beginning in post-operative care unit and continuing 24 hours on the post-operative floor.
Opioid Consumption
Measured by IV narcotic consumption beginning in the post-operative care unit and continuing 24 hours on the post-operative floor.
Secondary Outcome Measures
Post-Operative Care Unit (PACU) Length of Stay
Length of PACU stay is measured from arrival in PACU to clinical discharge from PACU
Full Information
NCT ID
NCT02299271
First Posted
November 19, 2014
Last Updated
February 7, 2017
Sponsor
The Christ Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02299271
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Preliminary analysis showed no difference between groups.
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Christ Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ropivacaine block
Arm Type
Active Comparator
Arm Description
Ropivacaine 0.375% as a one-time 60 milliliter injection.
Arm Title
saline block
Arm Type
Placebo Comparator
Arm Description
Sodium chloride 0.9% as a one-time 60 milliliter injection.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
0.375% ropivacaine as a one-time, 60 milliliter injection
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Sodium Chloride 0.9%
Intervention Description
Saline as a one-time, 60 milliliter injection.
Primary Outcome Measure Information:
Title
Pain Control
Description
Measured by NRS-11 beginning in post-operative care unit and continuing 24 hours on the post-operative floor.
Time Frame
24 hours
Title
Opioid Consumption
Description
Measured by IV narcotic consumption beginning in the post-operative care unit and continuing 24 hours on the post-operative floor.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Post-Operative Care Unit (PACU) Length of Stay
Description
Length of PACU stay is measured from arrival in PACU to clinical discharge from PACU
Time Frame
From 60 minutes to 6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Vaughan, MD
Organizational Affiliation
The Christ Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23558369
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.
Results Reference
background
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Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty
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