The Effect of Fascia Iliaca Compartment Block (FICB) on QoR-15 Score in Partial Hip Arthroplasty Surgery

NCT ID: NCT05965544

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-02

Study Completion Date

2024-05-14

Brief Summary

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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.

Detailed Description

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American Society of Anesthesiologists (ASA) physical status I-III patients who are planned for partial hip arthroplasty will be studied in patients over 65 years of age. The patients will be 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 will be named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal). 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% isobaric bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle through the L3-L4 or L4-L5 intervertebral space. After the patients are in the supine position and aseptic conditions are provided, the fascia on the Iliacus muscle will be determined with the help of an 8-12 MHz linear probe, and the block will be applied with the in-plane technique. During the block, patients will routinely administer 0.2% bupivacaine concentration of 0.5 mL/kg. Demographic data, operation time, perioperative analgesic and sedation need, postoperative pain scores, additional analgesic need, hospitalization and 24th-hour recovery scores will be evaluated.

Conditions

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Post Operative Pain Anesthesia, Local Fracture of Hip QoR-15

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
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.

Study Groups

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Group PreS

The block will be applied in the preoperative period

Group Type ACTIVE_COMPARATOR

Bupivacain (preoperative)

Intervention Type DRUG

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.

Bupivacaine-fentanyl

Intervention Type DRUG

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

Group PostS

The block will be applied in the postoperative period

Group Type ACTIVE_COMPARATOR

Bupivacaine-fentanyl

Intervention Type DRUG

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

Bupivacain (Postoperative)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Preoperative Fascia Iliaca Compartment Block Spinal Anesthesia Postoperative Fascia Iliaca Compartment Block

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ergün Mendeş

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ergun Mendes

Role: PRINCIPAL_INVESTIGATOR

Başakşehir Çam & Sakura City Hospital

Locations

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Ergun Mendes

Küçükçekmece, İ̇stanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Selvi O, Azizoglu M, Temel G, Tulgar S, Chitneni A, Cinar EN, Ozer Z, Gurkan Y. Translation and Validation of the Turkish Version of the Quality of Postoperative Recovery Score QoR-15: A Multi-Centred Cohort Study. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):443-448. doi: 10.5152/TJAR.2022.21417.

Reference Type BACKGROUND
PMID: 36511494 (View on PubMed)

Mendes E, Adiyeke O, Sarban O, Civan M, Ozcan FG. Timing of suprainguinal fascia iliaca block in hip hemiarthroplasty: impact on QoR-15 scores- a prospective randomized study. BMC Anesthesiol. 2025 Apr 12;25(1):179. doi: 10.1186/s12871-025-03060-8.

Reference Type DERIVED
PMID: 40221676 (View on PubMed)

Other Identifiers

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KAEK/2023.06.259

Identifier Type: OTHER

Identifier Source: secondary_id

e.mendes - 2

Identifier Type: -

Identifier Source: org_study_id

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