Clinical trial

The Effect of Application of Fascia Iliaca Compartment Block (FICB) Before or After Spinal Anesthesia on QoR-15 Score in Partial Hip Arthroplasty Surgery

Name

e.mendes - 2

Description

It reduces pain scores in patients with block and improves the quality of recovery in the postoperative period. In patients who will undergo spinal anesthesia, it will be questioned whether the application of the block before or after surgery makes a difference in the quality of recovery.

Trial arms

Trial start

2023-08-02

Estimated PCD

2024-05-14

Trial end

2024-05-14

Status

Completed

Treatment

Bupivacain (preoperative)

After the patients are in the supine position and aseptic conditions are provided in the preoperative period, the fascia on the iliacus muscle will be determined with the help of an 8-12 MHz linear probe and a block will be applied with the in-plane technique. During the block, 0.2% bupivacaine concentration 0.5 mL/kg is routinely used in patients.

Arms:

Group PreS

Other names:

Preoperative Fascia Iliaca Compartment Block

Bupivacaine-fentanyl

The patient will be placed in the lateral decubitus position with the fractured side up. After the spinal anesthesia method was provided with aseptic conditions, 10 mg 0.5% bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle through the L3-L4 or L4-L5 intervertebral space

Arms:

Group PostS, Group PreS

Other names:

Spinal Anesthesia

Bupivacain (Postoperative)

After the patients are in the supine position and aseptic conditions are provided in the postoperative period, the fascia on the iliacus muscle will be determined with the help of an 8-12 MHz linear probe and a block will be applied with the in-plane technique. During the block, 0.2% bupivacaine concentration 0.5 mL/kg is routinely used in patients.

Arms:

Group PostS

Other names:

Postoperative Fascia Iliaca Compartment Block

Size

Primary endpoint

Change from baseline QoR-15 at 24 hours postoperatively

Postoperative 24th-hours

Eligibility criteria

Inclusion Criteria: * Partial Hip Arthroplasty * American Society of Anesthesiologists (ASA) physical status I-III, * Patients aged ≥ 65 years Exclusion criteria: * Contraindication for central or peripheral blocks, * Cognitive Dysfunction, * History of chronic opioid use, * Previous hip surgery, * Serious organ dysfunction, * Allergy to any drug used in the study, * Body mass index (BMI) ≥30, * Infection in the area to be treated, * Refusal to participate in the study

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients were equally randomized into two groups using a computer-generated random number table. In the preoperative period, according to whether FIBP was before or after spinal anesthesia, it was named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal).', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "After each patient's eligibility has been assessed, numbered and sealed envelopes will be used to conceal assignment status. The same clinician (E.M.) will perform the patient's pre- and post-operative procedures. A researcher who does not know which method was applied to the patient in the perioperative and postoperative follow-ups will be included as double-blind.", 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2024-05-16

1 organization

2 products

5 indications

Organization

Başakşehir Çam & Sakura City Hospital

Product

Bupivacain

Indication

Postoperative Pain

Indication