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Comparison of The Continous Suprainguinal Fascia Iliaca Compartment Block and Continous Epidural

U

Udayana University

Status

Invitation-only

Conditions

Pain, Postoperative

Treatments

Other: Continuous Epidural
Other: Continuous Suprainguinal Fascia Iliaca Compartment Block

Study type

Interventional

Funder types

Other

Identifiers

NCT06636331
Udayana University

Details and patient eligibility

About

This study evaluates the effectiveness of postoperative analgesia quality, Interleukin-6, Hemodynamic stability and QoR-40 of continuous Suprainguinal Fascia Iliaca Compartment Block (S-FICB) compared with continuous epidural in patients undergoing cephalomedullary nailing surgery.

Half of participants will receive continuous S-FICB with patient control regional analgesia using ropivacaine 0.2% continue 2ml/hr and demand dose 5ml as needed, while the other half will receive continuous epidural with patient control epidural analgesia using same regimen.

Full description

The Continuous Suprainguinal Fascia Iliaca Compartment Block (S-FICB) and continuous epidural are regional anaesthesia that can be used to relieve postoperative pain of femur surgery. But there are few studies have been done to compare both techniques.

The S-FICB is an alternate peripheral nerve block technique using local anaesthetic administered into the fascia iliaca compartment at the inguinal region which targets the femoral, obturator and lateral femoral cutaneous nerves.

The epidural is well known and proven to have an adequate analgesia effect using local anaesthetic in the epidural region targeted for femur surgery.

Based on previous studies, the effectiveness of the S-FICB single shot was no longer than 18 hours. Then we choose to continue S-FICB to find out how adequate it is. The S-FICB with ropivacaine has a proven anti-inflammatory effect for the first 24 hours postoperative.

Enrollment

46 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients is planned for cephalomedullary nailing surgery
  2. Patients with BMI 18 - 30 kg/m2
  3. Patients with ASA physical status I - III

Exclusion criteria

  1. Patients with contraindications to regional anesthesia
  2. Patients with mental disorders or psychiatric disorders
  3. Patients have a history of allergy to the local anesthetic drug
  4. Patients or family refused to participate in the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

46 participants in 2 patient groups

Treatment S-FICB Arm
Experimental group
Description:
S-FICB with PCRA using Ropivacaine 0.2% continuous 2ml/hr, demand dose 5ml as needed.
Treatment:
Other: Continuous Suprainguinal Fascia Iliaca Compartment Block
Treatment Epidural Arm
Experimental group
Description:
Epidural with PCEA using Ropivacaine 0.2% continuous 2ml/hr, demand dose 5ml as needed.
Treatment:
Other: Continuous Epidural

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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