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Clinical Trials/NCT05965544
NCT05965544
Completed
Not Applicable

The Effect of Application of Fascia Iliaca Compartment Block (FICB) Before or After Spinal Anesthesia on QoR-15 Score in Partial Hip Arthroplasty Surgery

Başakşehir Çam & Sakura City Hospital1 site in 1 country60 target enrollmentAugust 2, 2023

Overview

Phase
Not Applicable
Intervention
Bupivacain (preoperative)
Conditions
Post Operative Pain
Sponsor
Başakşehir Çam & Sakura City Hospital
Enrollment
60
Locations
1
Primary Endpoint
Change from baseline QoR-15 at 24 hours postoperatively
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2, 2023
End Date
May 14, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Başakşehir Çam & Sakura City Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ergün Mendeş

Principal Investigator

Başakşehir Çam & Sakura City Hospital

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,

Exclusion Criteria

  • Not provided

Arms & Interventions

Group PreS

The block will be applied in the preoperative period

Intervention: Bupivacain (preoperative)

Group PreS

The block will be applied in the preoperative period

Intervention: Bupivacaine-fentanyl

Group PostS

The block will be applied in the postoperative period

Intervention: Bupivacaine-fentanyl

Group PostS

The block will be applied in the postoperative period

Intervention: Bupivacain (Postoperative)

Outcomes

Primary Outcomes

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

  • 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 Sites (1)

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