Quality of pain management with a nerve block applied for muscle sparing total hip arthroplasty

Fascia iliaca block for analgesia in unilateral direct anterior approach total hip arthroplasty

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003695-31-BE

Enrollment

Registered

2017-10-02

Start date

2017-12-04

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total hip arthroplasty through minimal invasive muscle sparing surgery technique MedDRA version: 20.0 Level: PT Classification code 10020096 Term: Hip arthroplasty System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Marcaine 0.25% Product Name: Marcaine 0.25% Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Perineural use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Male or female, at least 18 years of age at screening. ? Scheduled to undergo unilateral DAA THA ? American Society of Anesthesiologists (ASA) physical status 1, 2 or 3 ? Able to demonstrate sensory function by exhibiting sensitivity to light touch ? Able to ambulate ? Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37

Exclusion criteria

Exclusion criteria: ? Previous open hip surgery ? History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics Contraindication to bupivacaine or morphine

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To compare total opioid consumption through the first postoperative week and the 29-day follow-up call of patients given bupivacaine 0.25% or normal saline prior to unilateral direct anterior approach total hip arthroplasty. To assess the onset and duration of sensory and motor blockade after fascia iliaca block for unilateral direct anterior approach total hip arthroplasty.;Main Objective: To determine analgesia efficacy through the first postoperative week and at the 29-day follow up call of patients given bupivacaine 0.25% or normal saline prior to unilateral direct anterior approach total hip arthroplasty.;Primary end point(s): NRS pain intensity scores reported through the first postoperative week and at the 29-day call;Timepoint(s) of evaluation of this end point: -NRS at baseline (on Day 0 prior to the nerve block and prior to any premedication); upon arrival to and discharge from the PACU; at 6, 12, 24, 48, 72 h (inpatient), at Days 4, 5, 6 and 7 (outpatient, by phone), and at the 29-day follow-up call.	—

Measure

Time frame

Secondary Objective: To compare total opioid consumption through the first postoperative week and the 29-day follow-up call of patients given bupivacaine 0.25% or normal saline prior to unilateral direct anterior approach total hip arthroplasty. To assess the onset and duration of sensory and motor blockade after fascia iliaca block for unilateral direct anterior approach total hip arthroplasty.;Main Objective: To determine analgesia efficacy through the first postoperative week and at the 29-day follow up call of patients given bupivacaine 0.25% or normal saline prior to unilateral direct anterior approach total hip arthroplasty.;Primary end point(s): NRS pain intensity scores reported through the first postoperative week and at the 29-day call;Timepoint(s) of evaluation of this end point: -NRS at baseline (on Day 0 prior to the nerve block and prior to any premedication); upon arrival to and discharge from the PACU; at 6, 12, 24, 48, 72 h (inpatient), at Days 4, 5, 6 and 7 (outpatient, by phone), and at the 29-day follow-up call.

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Secondary

Measure	Time frame
Secondary end point(s): Total postsurgical opioid consumption through the first postoperative week and at the 29-day call Extent and duration of sensory and motor block through the 3-day inpatient stay ;Timepoint(s) of evaluation of this end point: - Amount of opioid medication taken (IVPCA or oral) through the first 24 h, to the 48 and 72 h timepoints inclusive, at Days 4, 5, 6 and 7 (inclusive) and at the 29-day follow-up call. ? ? Sensory assessment (as measured by light touch testing) and degree of femoral nerve motor block (strength and angle of knee extension), degree of the obturator nerve block (adduction of the thigh) at baseline (on Day 0 prior to the nerve block); at approximately 15 and 30 minutes after the FIB; upon arrival at the PACU and at 12, 24 and 72 hours.	—

Measure

Time frame

Secondary end point(s): Total postsurgical opioid consumption through the first postoperative week and at the 29-day call Extent and duration of sensory and motor block through the 3-day inpatient stay ;Timepoint(s) of evaluation of this end point: - Amount of opioid medication taken (IVPCA or oral) through the first 24 h, to the 48 and 72 h timepoints inclusive, at Days 4, 5, 6 and 7 (inclusive) and at the 29-day follow-up call. ? ? Sensory assessment (as measured by light touch testing) and degree of femoral nerve motor block (strength and angle of knee extension), degree of the obturator nerve block (adduction of the thigh) at baseline (on Day 0 prior to the nerve block); at approximately 15 and 30 minutes after the FIB; upon arrival at the PACU and at 12, 24 and 72 hours.

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Countries

Belgium

Contacts

Public ContactCatherine Vandepitte

Ziekenhuis Oost-Limburg

catherine@nysora.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026