NCT06102811

Brief Summary

Fascia iliaca compartment block (FICB) is a documented option for postoperative analgesia for total hip arthroplasty (THA) surgery. FICB is demonstrated to be effective in terms of analgesia and opioid requirements decrease, however it causes quadriceps motor weakness. Current available motor sparing techniques are not as effective as FICB for analgesia. Low concentration local anesthetics (LCLA) are used with excellent results for pain control with no or minimum motor block effect, in other scenarios (highlighted in obstetric anesthesia) and techniques (epidural anesthesia, for instance). This study proposes that LCLA-FICB can offer the benefit of peripheral nerve blocks mediated analgesia, while at the same time avoiding motor blockade and muscle weakness. The investigators hypothesize that LCLA-FICB, when compared to conventional high concentration local anesthetics (HCLA) FICB, provides similar postoperative analgesia in the first 24 hours following primary THA, while at the same time preserving quadriceps muscle group strength.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

October 23, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

2.2 years

First QC Date

October 22, 2023

Last Update Submit

June 25, 2025

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

  • Quadriceps muscle strenght

    Intensity of quadriceps strength: Muscle Strength Grading (Oxford Scale): 0 - no muscle activation; 1 - trace muscle activation, such as a twitch, without achieving full range of motion; 2 - muscle activation with gravity eliminated, achieving full range of motion; 3 - muscle activation against gravity, full range of motion; 4 - muscle activation against some resistance, full range of motion; 5 - muscle activation against examiner's full resistance, full range of motion.

    4 hours after spinal anesthesia

Secondary Outcomes (2)

  • Pain scores

    24 hours after spinal anesthesia

  • Opioid consumption

    24 hours after spinal anesthesia

Study Arms (2)

Low Concentration Local Anesthetic Fascia Iliaca Compartment Block

EXPERIMENTAL

Patients will be submitted to a Suprainguinal Fascia Iliaca Block with low concentration local anesthetic (Ropivacaine 0.075%)

Other: Low Concentration Local Anesthetic Fascia Iliaca Compartment Block

High Concentration Local Anesthetic Fascia Iliaca Compartment Block

ACTIVE COMPARATOR

Patients will be submitted to a Suprainguinal Fascia Iliaca Block with high concentration local anesthetic (Ropivacaine 0.25%)

Other: High Concentration Local Anesthetic Fascia Iliaca Compartment Block

Interventions

Low Concentration Local Anesthetic Fascia Iliaca Compartment BlockOTHER

Fascia iliaca block with Ropivacaine 0.075% (50 mL)

Low Concentration Local Anesthetic Fascia Iliaca Compartment Block
High Concentration Local Anesthetic Fascia Iliaca Compartment BlockOTHER

Fascia iliaca block with Ropivacaine 0.25% (50 mL)

High Concentration Local Anesthetic Fascia Iliaca Compartment Block

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing primary THA in the inpatient setting.
  • Non-pregnant patients older than 21 years of age.
  • Patients with American Society of Anesthesiologists (ASA) physical status I-IV.
  • No alcohol or drug dependency.

You may not qualify if:

  • Patients undergoing outpatient THA.
  • Chronic opioid use of 30 mg or more of oral morphine equivalent, per day, for the last 2 consecutive weeks.
  • Contraindications for nerve block placement (severe anatomic abnormalities, local or systemic infection).
  • Contraindications for any of the standardized medications used for the study (Mepivacaine, Fentanyl, Dexamethasone, Ondansetron, Acetaminophen, Celecoxib, Hydromorphone).
  • Not submitted to the standardized spinal anesthesia technique.
  • Need to conversion to general anesthesia after the start of the surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Related Publications (5)

  • Anger M, Valovska T, Beloeil H, Lirk P, Joshi GP, Van de Velde M, Raeder J; PROSPECT Working Group* and the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Aug;76(8):1082-1097. doi: 10.1111/anae.15498. Epub 2021 May 20.

    PMID: 34015859BACKGROUND

  • Panzenbeck P, von Keudell A, Joshi GP, Xu CX, Vlassakov K, Schreiber KL, Rathmell JP, Lirk P. Procedure-specific acute pain trajectory after elective total hip arthroplasty: systematic review and data synthesis. Br J Anaesth. 2021 Jul;127(1):110-132. doi: 10.1016/j.bja.2021.02.036.

    PMID: 34147158BACKGROUND

  • Li D, Yang Z, Xie X, Zhao J, Kang P. Adductor canal block provides better performance after total knee arthroplasty compared with femoral nerve block: a systematic review and meta-analysis. Int Orthop. 2016 May;40(5):925-33. doi: 10.1007/s00264-015-2998-x. Epub 2015 Oct 10.

    PMID: 26452678BACKGROUND

  • Bugada D, Bellini V, Lorini LF, Mariano ER. Update on Selective Regional Analgesia for Hip Surgery Patients. Anesthesiol Clin. 2018 Sep;36(3):403-415. doi: 10.1016/j.anclin.2018.04.001. Epub 2018 Jul 11.

    PMID: 30092937BACKGROUND

  • Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18.

    PMID: 20966667BACKGROUND

Study Officials

  • Hermann dos Santos Fernandes, MD, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hermann dos Santos Fernandes, MD, PhD

CONTACT

416-586-5270hermannfernandes@yahoo.com.br

Yehoshya Gleicher, MD, MSc

CONTACT

416-586-5270josh.gleicher@sinaihealth.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 22, 2023

First Posted

October 26, 2023

Study Start

October 23, 2023

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Anonymized, if requested

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After publishing the study. No time limit.
Access Criteria
If requested

Locations

CA(1)