CMP vs Fascia Iliaca Block

NCT ID: NCT04426058

Last Updated: 2022-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-06

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CMP

Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml

Group Type EXPERIMENTAL

CMP

Intervention Type DRUG

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

Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml

Group Type ACTIVE_COMPARATOR

Fascia Illica

Intervention Type DRUG

Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml

Interventions

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CMP

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

Fascia Illica

Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loyola University

OTHER

Sponsor Role lead

Responsible Party

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Scott Byram MD

MD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Loyola University Medical Center

Maywood, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Carlos Martinez Parra, MD

Role: CONTACT

(708) 216-6462

Michael Majewski, MD

Role: CONTACT

(708) 216-6462

Facility Contacts

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Scott Byram, MD

Role: primary

713-216-5988

References

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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.

Reference Type BACKGROUND
PMID: 30386023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30386022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30063657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31371038 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26767235 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://rapm.bmj.com/content/early/2019/05/16/rapm-2018-100174?versioned=true

Randomized trial of ultrasound-guided superior cluneal nerve block

Other Identifiers

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213048

Identifier Type: -

Identifier Source: org_study_id

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