CMP vs Fascia Iliaca Block

Pain, Postoperative Clinical Trial

Official title:

Complete Motor Sparing Protocol Versus Fascia Iliaca Suprainguinal Technique for Total Hip Arthroplasty, a Prospective Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04426058
• Other study ID #: 213048
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Loyola University
• Contact: Carlos Martinez Parra, MD
• Phone: (708) 216-6462
• Email: carlos.martinezparra[@]lumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthroplasty
• Pain, Postoperative

Intervention

Drug:
• CMP
Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml
• Fascia Illica
Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Girón-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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of opioid use	Measurement of opioid use (mg) for pain control after surgery once patient in recovery area	24 hours
Secondary	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.	24 hours

External Links

•   Comparing the efficacy of pain managements after total hip arthroplasty: A network meta-analysis
•   Randomized trial of ultrasound-guided superior cluneal nerve block