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Completed

NCT Number: NCT05965544

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

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.

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Key information

Conditions

Post Operative Pain Anesthesia, Local Femoral Fractures Fracture of Hip Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications QoR-15 Signs and Symptoms Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ergun Mendes

Küçükçekmece, İ̇stanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Preoperative Fascia Iliaca Compartment Block

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

Other names: Spinal Anesthesia

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.

Other names: Postoperative Fascia Iliaca Compartment Block

Primary outcomes

  1. Change from baseline QoR-15 at 24 hours postoperatively

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Postoperative nausea and vomiting

    Time frame: 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.

  3. Analgesic consumption

    Time frame: Postoperative 24th hour

    The value in mg of the amount of analgesic consumed in the postoperative period

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study 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

Acronym: QoR-15

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2023
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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