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

Not Applicable

Completed

• Conditions: Post Operative Pain; Anesthesia, Local; Fracture of Hip; QoR-15
• Interventions: Drug: Bupivacain (preoperative); Drug: Bupivacaine-fentanyl; Drug: Bupivacain (Postoperative)

• Registration Number: NCT05965544
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-07-28
• Study Start: 2023-08-02
• Status Verified: 2024-05
• Primary Completion: 2024-05-14
• Study Completion: 2024-05-14
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group PreS	Bupivacain (preoperative)	The block will be applied in the preoperative period
Group PreS	Bupivacaine-fentanyl	The block will be applied in the preoperative period
Group PostS	Bupivacaine-fentanyl	The block will be applied in the postoperative period
Group PostS	Bupivacain (Postoperative)	The block will be applied in the postoperative period

Primary Outcome Measures

Name	Time	Method
Change from baseline QoR-15 at 24 hours postoperatively	Postoperative 24th-hours	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline Nursing Delirium Screening Scale (N-DSS) at 24 hours postoperatively	Postoperative 24th-hours	Postoperative delirium will be determined with the Nursing Delirium Screening Scale (N-DSS), an easily applicable five-item screening tool that evaluates disorientation, inappropriate behavior, inappropriate communication, hallucination, and psychomotor retardation. Each item scores between 0 and 2 and the total score varies between 0 and 10.
Postoperative nausea and vomiting	Postoperative 24th hour	The frequency of nausea and vomiting in the postoperative period was calculated according to the Numeric Rank Score (NRS), which ranged from 0 to 3. Nausea-vomiting status of the patients: 0 points if there is no nausea and vomiting; 1 point if there is nausea, no vomiting; It is scored as 2 points if there is vomiting once and 3 points if there are two or more vomiting attacks.
Analgesic consumption	Postoperative 24th hour	The value in mg of the amount of analgesic consumed in the postoperative period

Trial Locations

Locations (1)

Ergun Mendes; 🇹🇷 Küçükçekmece, İ̇stanbul, Turkey