CMP vs Fascia Iliaca Block
April 12, 2022 updated by: Scott Byram MD, Loyola University
Complete Motor Sparing Protocol Versus Fascia Iliaca Suprainguinal Technique for Total Hip Arthroplasty, a Prospective Randomized Clinical Trial.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carlos Martinez Parra, MD
- Phone Number: (708) 216-6462
- Email: carlos.martinezparra@lumc.edu
Study Contact Backup
- Name: Michael Majewski, MD
- Phone Number: (708) 216-6462
- Email: mimajewski@lumc.edu
Study Locations
-
-
Illinois
-
Maywood, Illinois, United States, 60153
- Recruiting
- Loyola University Medical Center
-
Contact:
- Scott Byram, MD
- Phone Number: 713-216-5988
- Email: sbyram@lumc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: CMP
Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml
|
Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml
|
|
ACTIVE_COMPARATOR: Fascia iliaca
Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml
|
Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of opioid use
Time Frame: 24 hours
|
Measurement of opioid use (mg) for pain control after surgery once patient in recovery area
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of the pain control
Time Frame: 24 hours
|
Measurement of the pain control via numeric rating scale 0-10 where 0 is no pain and 10 is the worst pain.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 6, 2020
Primary Completion (ANTICIPATED)
December 31, 2022
Study Completion (ANTICIPATED)
December 31, 2022
Study Registration Dates
First Submitted
May 13, 2020
First Submitted That Met QC Criteria
June 9, 2020
First Posted (ACTUAL)
June 11, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 20, 2022
Last Update Submitted That Met QC Criteria
April 12, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 213048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.