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Fascia Iliaca Compartment Block for Pain Management in Hip Fracture Patients

NCT04837924 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-08-03

No results posted yet for this study

Summary

BLOCKPAIN is a randomized controlled study, 80 participants. The participants will be hip fracture patients in Emergency Medicine Department in Clinical Hospital "Sveti Duh", Zagreb, Croatia. Upon patient arrival inclusion and exclusion criteria will be established. After signing the informed consent form participant will be randomized in one of two study groups. One study group is fascia iliaca compartment block (FICB), the other is placebo. All participants will be given paracetamol 1 gram IV as standard care. If needed, rescue analgesic will be tramadol 100 mg in 100 ml saline IV. The time frame is 24 hours after the FICB or placebo procedure.

Conditions

  • Hip Fractures

Interventions

PROCEDURE

fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml)

Land mark technique will be used to perform FICB on the side of the hip fracture. The injection site is one centimetre caudal from the junction between medial 2/3 and lateral 1/3 in the imaginary line between anterior superior iliac spine and ipsilateral pubic tubercle. The goal is to administer local anesthetic in the fascia iliaca compartment.

DRUG

paracetamol 1 gram IV

paracetamol 1 gram IV every six hours, 4 times in 24 hours

DRUG

Rescue analgesic tramadol 100 mg IV if needed

Rescue analgesic, if needed, tramadol 100 mg in 100 ml saline (0,9% Sodium chloride) IV, up to 4 times in 24 hours

PROCEDURE

Sham injection

Sting with blunt needle, (without piercing the skin), same site as fascia iliaca compartment block

Sponsors & Collaborators

  • General Hospital Sveti Duh

    lead OTHER

Principal Investigators

  • Anđela Simić · Clinical Hospital "Sveti Duh"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-21
Primary Completion
2022-05-26
Completion
2022-05-27

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04837924 on ClinicalTrials.gov