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

NCT05965544 | Completed

• 2 other identifiers: e.mendes - 2KAEK/2023.06.259
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Fascia Iliaca Compartment Block; FICB; Partial Hip Arthroplasty Surgery; Quality of Recovery-15

Outcome Measures

Primary Outcomes (1)

• Change from baseline QoR-15 at 24 hours postoperatively

  The patient-reported Turkish QoR-15 score includes 15 questions that evaluate the patient's postoperative recovery. The QoR-15 score is grouped under two groups, A and B. A high QoR-15 score, a score between 0 (poor) and 10 (excellent) for each item, and a total score of 150 indicate better quality of recovery.

  Postoperative 24th-hours

Secondary Outcomes (3)

• Change from baseline Nursing Delirium Screening Scale (N-DSS) at 24 hours postoperatively

  Postoperative 24th-hours

• Postoperative nausea and vomiting

  Postoperative 24th hour

• Analgesic consumption

  Postoperative 24th hour

Study Arms (2)

Group PreS

ACTIVE COMPARATOR

The block will be applied in the preoperative period

Drug: Bupivacain (preoperative); Drug: Bupivacaine-fentanyl

Group PostS

ACTIVE COMPARATOR

The block will be applied in the postoperative period

Drug: Bupivacaine-fentanyl; Drug: Bupivacain (Postoperative)

Interventions

Bupivacain (preoperative) 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.

Also known as: Preoperative Fascia Iliaca Compartment Block

Group PreS

Bupivacaine-fentanyl 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

Also known as: Spinal Anesthesia

Group PostS; Group PreS

Bupivacain (Postoperative) 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.

Also known as: Postoperative Fascia Iliaca Compartment Block

Group PostS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Partial Hip Arthroplasty
• American Society of Anesthesiologists (ASA) physical status I-III,
• Patients aged ≥ 65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Ergun Mendes

Küçükçekmece, İ̇stanbul, 34000, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 36511494 BACKGROUND

• 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.

  PMID: 40221676 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Hip Fractures

Interventions

Anesthesia, Spinal; Postoperative Period

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ergun Mendes

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 28, 2023
• Study Start: August 2, 2023
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)