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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04426058
Other study ID # 213048
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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