Back to resultsCMP vs Fascia Iliaca Block
Primary Purpose
Pain, Postoperative, Hip Arthroplasty
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CMP
Fascia Illica
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Nerve Block, Fascia Iliaca Nerve Block, Complete Motor Sparing Protocol, Hip Arthroplasty, Pain control
Eligibility Criteria
Inclusion Criteria:
- Patients ≥ 18 years old
- Patients undergoing total hip arthroplasty posterior approach.
- Patients willing to participate and sign informed consent
Exclusion Criteria:
- Severe COPD/other contraindication to general anesthesia that spinal would be more suitable.
- Patient with a weight of less than 41 kg
- Dementia, not alert or Oriented to person, place, or time
- Chronic pain patient with daily opioid use at home.
- Patient with allergy to local anesthetics
- Patient refusal
- Total hip arthroplasty revision
- Concomitant pain in different area from operative site.
- Pregnancy
- Patient with active infection on the injection sites for the blocks
- Patients unable or willing to understand or comply with the study protocol
Sites / Locations
- Loyola University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CMP
Fascia iliaca
Arm Description
Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml
Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml
Outcomes
Primary Outcome Measures
Measurement of opioid use
Measurement of opioid use (mg) for pain control after surgery once patient in recovery area
Secondary Outcome Measures
Measurement of the pain control
Measurement of the pain control via numeric rating scale 0-10 where 0 is no pain and 10 is the worst pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04426058
Brief Title
CMP vs Fascia Iliaca Block
Official Title
Complete Motor Sparing Protocol Versus Fascia Iliaca Suprainguinal Technique for Total Hip Arthroplasty, a Prospective Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Complete motorsparing protocol (CMP) has been developed to try to minimize the motor nerve block that is created when using Facia iliaca nerve block. The blocks performed in the (CMP) are the cluneal nerve block, Pericapsular nerve group block and lateral femoral cutaneous block. On the clinical trial, the investigators will randomize the participants that meet criteria to CMP or Fascia iliaca Block and compare the amount of opioid needed post op during 24 hours and their pain scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Hip Arthroplasty
Keywords
Nerve Block, Fascia Iliaca Nerve Block, Complete Motor Sparing Protocol, Hip Arthroplasty, Pain control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CMP
Arm Type
Experimental
Arm Description
Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml
Arm Title
Fascia iliaca
Arm Type
Active Comparator
Arm Description
Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml
Intervention Type
Drug
Intervention Name(s)
CMP
Intervention Description
Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml
Intervention Type
Drug
Intervention Name(s)
Fascia Illica
Intervention Description
Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml
Primary Outcome Measure Information:
Title
Measurement of opioid use
Description
Measurement of opioid use (mg) for pain control after surgery once patient in recovery area
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Measurement of the pain control
Description
Measurement of the pain control via numeric rating scale 0-10 where 0 is no pain and 10 is the worst pain.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients ≥ 18 years old
Patients undergoing total hip arthroplasty posterior approach.
Patients willing to participate and sign informed consent
Exclusion Criteria:
Severe COPD/other contraindication to general anesthesia that spinal would be more suitable.
Patient with a weight of less than 41 kg
Dementia, not alert or Oriented to person, place, or time
Chronic pain patient with daily opioid use at home.
Patient with allergy to local anesthetics
Patient refusal
Total hip arthroplasty revision
Concomitant pain in different area from operative site.
Pregnancy
Patient with active infection on the injection sites for the blocks
Patients unable or willing to understand or comply with the study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Martinez Parra, MD
Phone
(708) 216-6462
Email
carlos.martinezparra@lumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Majewski, MD
Phone
(708) 216-6462
Email
mimajewski@lumc.edu
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Byram, MD
Phone
713-216-5988
Email
sbyram@lumc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30386023
Citation
Tyagi A, Salhotra R. Total hip arthroplasty and peripheral nerve blocks: Limited but salient role? J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):379-380. doi: 10.4103/joacp.JOACP_114_18. No abstract available.
Results Reference
background
PubMed Identifier
30386022
Citation
Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.
Results Reference
background
PubMed Identifier
30063657
Citation
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
Results Reference
background
PubMed Identifier
31371038
Citation
Hannon CP, Keating TC, Lange JK, Ricciardi BF, Waddell BS, Della Valle CJ. Anesthesia and Analgesia Practices in Total Joint Arthroplasty: A Survey of the American Association of Hip and Knee Surgeons Membership. J Arthroplasty. 2019 Dec;34(12):2872-2877.e2. doi: 10.1016/j.arth.2019.06.055. Epub 2019 Jul 8.
Results Reference
background
PubMed Identifier
26767235
Citation
Kumar K, Pandey RK, Bhalla AP, Kashyap L, Garg R, Darlong V, Malhotra R, Yadav CS. Comparison of conventional infrainguinal versus modified proximal suprainguinal approach of Fascia Iliaca Compartment Block for postoperative analgesia in Total Hip Arthroplasty. A prospective randomized study. Acta Anaesthesiol Belg. 2015;66(3):95-100.
Results Reference
background
Links:
URL
https://rapm.bmj.com/content/early/2019/05/16/rapm-2018-100174?versioned=true
Description
Randomized trial of ultrasound-guided superior cluneal nerve block
Learn more about this trial
CMP vs Fascia Iliaca Block
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