NCT06389279

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

April 24, 2024

Last Update Submit

April 30, 2024

Conditions

Keywords

regional anesthesiapostoperative painrecovery qualityhip fracture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • postoperative Numeric Rating Scale (NRS) pain score

    postoperative 24 hours

  • postoperative opioid consumption

    postoperative 24 hours

Study Arms (4)

PENG block group

Before the spinal anesthesia, PENG block will be performed under the guidance of ultrasound.

Other: PENG block group

FIC block group

Before the spinal anesthesia, FIC block will be performed under the guidance of ultrasound.

Other: FIC block group

Femoral block group

Before the spinal anesthesia, femoral block will be performed under the guidance of ultrasound.

Other: Femoral block group

Control group

No intervention

Other: Control group

Interventions

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.

PENG 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.

FIC 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.

Femoral block group

No intervention

Control group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

It is planned to include ASA I-III patients between the ages of 1-85 who are planned to undergo hip fracture surgery under elective spinal anesthesia.

You may qualify if:

  • elective hip fracture,
  • years
  • American Society of Anaesthesiology (ASA) I-III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Antalya Training and Researh Hospital

Antalya, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 36620112BACKGROUND
  • 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.

    PMID: 36964012BACKGROUND

MeSH Terms

Conditions

Hip FracturesPain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Arzu Karaveli, M.D.

    University of Health Sciences, Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2024

First Posted

April 29, 2024

Study Start

April 30, 2024

Primary Completion

September 24, 2024

Study Completion

October 24, 2024

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations