does a regional hip anesthesia technique reduce pain after hip arthroplasty

Longitudinal Fascia Iliaca Compartment Block for Total Hip Arthroplasty - FICB1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002122-12-BE

Enrollment

100

Registered

2014-06-19

Start date

2014-07-17

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

Our hypothesis is that a longitudinal approach to the fascia iliaca with a larger volume of local anesthetic will decrease morphine consumption and pain scores in patients after total hip arthroplasty compared to a control group. We will test our hypothesis in a double blind, randomized, placebo controlled trial. MedDRA version: 17.0 Level: LLT Classification code 10044088 Term: Total hip replacement System Organ Class: 100000004865

Interventions

Trade Name: naropin Product Name: naropin Product Code: N01BB09 Pharmaceutical Form: Injection INN or Proposed INN: naropin CAS Number: 132112-35-7 Other descriptive name: ROPIVACAINE HYDROCHLORIDE MO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: After obtaining written, informed consent patients presenting for primary THA will be included in the study. 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 44 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 44

Exclusion criteria

Exclusion criteria: Exclusion criteria will be age 35, intolerance to any of the drugs used in the study, opioid dependency and coagulopathy.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary endpoint of the study will be total morfine consumption during the first 24 hours. ;Secondary Objective: Secondary endpoints will be morphine consumption at 48 hours, pain scores, postoperative nausea and vomiting and number of blocked nerves using respons to pinprick in the sensory territories of the different nerves (femoral, obturator and lateral cutaneous).;Primary end point(s): The primary endpoint of the study will be total morfine consumption during the first 24 hours. ;Timepoint(s) of evaluation of this end point: Total Morphine consumption at 24 hours.	—

Measure

Time frame

Main Objective: The primary endpoint of the study will be total morfine consumption during the first 24 hours. ;Secondary Objective: Secondary endpoints will be morphine consumption at 48 hours, pain scores, postoperative nausea and vomiting and number of blocked nerves using respons to pinprick in the sensory territories of the different nerves (femoral, obturator and lateral cutaneous).;Primary end point(s): The primary endpoint of the study will be total morfine consumption during the first 24 hours. ;Timepoint(s) of evaluation of this end point: Total Morphine consumption at 24 hours.

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints will be morphine consumption at 48 hours, pain scores, postoperative nausea and vomiting and number of blocked nerves using respons to pinprick in the sensory territories of the different nerves (femoral, obturator and lateral cutaneous).;Timepoint(s) of evaluation of this end point: Total Morphine consumption at 48 hours.	—

Countries

Belgium

Contacts

Public Contactkris vermeylen

az turnhout

kris.vermeylen@gmail.com3214406747

Outcome results

None listed

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