Clinical trial NCT05965544: The Effect of Fascia Iliaca Compartment Block (FICB) on QoR-15 Score in Partial Hip Arthroplasty Surgery
Official title: The Effect of Application of Fascia Iliaca Compartment Block (FICB) Before or After Spinal Anesthesia on QoR-15 Score in Partial Hip Arthroplasty Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline QoR-15 at 24 hours postoperatively
timeFrame: Postoperative 24th-hours
Secondary outcomes:
measure: Change from baseline Nursing Delirium Screening Scale (N-DSS) at 24 hours postoperatively
timeFrame: Postoperative 24th-hours
measure: Postoperative nausea and vomiting
timeFrame: Postoperative 24th hour
measure: Analgesic consumption
timeFrame: Postoperative 24th hour
Other outcomes:
Locations:
city: Küçükçekmece
country: Turkey
facility: Ergun Mendes
state: İ̇stanbul
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Ergun Mendes
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.