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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06389279
Other study ID # 2023-18/11
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 30, 2024
Est. completion date October 24, 2024

Study information

Verified date April 2024
Source Antalya Training and Research Hospital
Contact Arzu Karaveli
Phone + 90 2422494400
Email arzukaraveli@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study was to evaluate the effect of ultrasound-guided pericapsular nerve block, fascia iliaca compartment block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia.


Description:

Orthopedic procedures have become increasingly common in clinical practice. With the increasing elderly population, there have been significant developments in recent years in the field of perioperative pain management and anesthesia strategies for patients scheduled for hip surgery. Patients undergoing hip surgery may experience severe pain both postoperatively and during the positioning of the patient during surgery. This leads to increased sympathetic activation such as tachycardia and hypertension in patients, especially in the elderly population, and some undesirable complications due to the patients' existing comorbidities. Therefore, pain management strategies for patients undergoing hip surgery are based on a range of anesthesia techniques, including the use of opioids, neuraxial anesthesia (spinal, epidural, or a combination of them), nerve blocks, especially pericapsular nerve block (PENG), fascia iliaca compartment block (FICB) and femoral block). Reducing patients' pain and improving the quality of postoperative recovery has become increasingly important. The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess postoperative recovery. This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the early postoperative period. The aim of this study was to evaluate the effect of ultrasound-guided PENG block, FICB block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date October 24, 2024
Est. primary completion date September 24, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - elective hip fracture, - 18-85 years - American Society of Anaesthesiology (ASA) I-III Exclusion Criteria: - patients planned for general anesthesia - with multiple fractures - bleeding disorder - peripheral neuropathy - mental disorder - local anesthetic allergy - contraindications for spinal anesthesia (local infection, etc.) - declining to give written informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
PENG block group
Ultrasound-guided PENG block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring.
FIC block group
Ultrasound-guided FIC block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring.
Femoral block group
Ultrasound-guided femoral block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring.
Control group
No intervention

Locations

Country Name City State
Turkey University of Health Sciences, Antalya Training and Researh Hospital Antalya

Sponsors (1)

Lead Sponsor Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Kalashetty MB, Channappagoudar R, Alwandikar V, Naik DL, Hulakund SY, Guddad A. Comparison of Pericapsular Nerve Group Block with Fascia Iliaca Compartment Block in Adult Patients Undergoing Hip Surgeries: A Double-Blinded Randomized Control Study. Anesth Essays Res. 2022 Jul-Sep;16(3):397-401. doi: 10.4103/aer.aer_123_22. Epub 2022 Dec 9. — View Citation

Kukreja P, Uppal V, Kofskey AM, Feinstein J, Northern T, Davis C, Morgan CJ, Kalagara H. Quality of recovery after pericapsular nerve group (PENG) block for primary total hip arthroplasty under spinal anaesthesia: a randomised controlled observer-blinded trial. Br J Anaesth. 2023 Jun;130(6):773-779. doi: 10.1016/j.bja.2023.02.017. Epub 2023 Mar 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary recovery quality The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess postoperative recovery. This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the early postoperative period. The patient is asked to express their status scoring from 0 to 10; therefore, the total score ranges from 0 to 150 points, 5 minutes
Secondary postoperative Numeric Rating Scale (NRS) pain score The postoperative pain intensity will be assessed with Numeric Rating Scale (NRS) scores (0 represents no pain and 10 represents the worst possible pain) at postoperative 24 hours. postoperative 24 hours
Secondary postoperative opioid consumption The amount of postoperative opioid consumption will be recorded postoperative 24 hours
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