NCT05549011

Brief Summary

This study aims to compare the effectiveness of preoperative ultrasound-guided suprainguinal fascia iliaca compartment block (SFICB) and pericapsular nerve group block (PENG) in preventing positioning pain during spinal anesthesia in patients who are scheduled for surgery due to hip fracture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

September 17, 2022

Last Update Submit

March 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Positioning pain during spinal anesthesia with 10-point numeric rating scale (NRS)

    NRS is a self-reported pain scale where patient defines intensity of their pain on a scale of 0 to 10. Zero means the patient has no pain while ten means the patient is experiencing the worst pain possible

    30 minutes after the block is placed

Secondary Outcomes (2)

  • Sitting angle during positioning

    30 minutes after the block is placed

  • Postoperative pain with 10-point numeric rating scale (NRS)

    Postoperative day 1

Study Arms (2)

PENG block

This cohort will include participants to whom a PENG block is performed before positioning for spinal anesthesia

Other: PENG BlockDiagnostic Test: Numeric Rating ScaleDiagnostic Test: Angle of sitting

SIFI block

This cohort will include participants to whom a SIFI compartment block is performed before positioning for spinal anesthesia

Other: SIFI compartment blockDiagnostic Test: Numeric Rating ScaleDiagnostic Test: Angle of sitting

Interventions

PENG block for analgesic purposes performed before hip surgery

PENG block

SIFI compartment block for analgesic purposes performed before hip surgery

SIFI block
Numeric Rating ScaleDIAGNOSTIC_TEST

Self-reported pain intensity score between 0-10

PENG blockSIFI block
Angle of sittingDIAGNOSTIC_TEST

Measurement of sitting angle in degrees with a protractor

PENG blockSIFI block

Eligibility Criteria

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

Participants will be recruited from a population of patients in a tertiary medical care center who are scheduled to undergo hip fracture surgery with spinal anesthetics and to whom either of the analgesic blocks PENG or SIFI compartment block is placed.

You may qualify if:

  • Adults with a hip fracture
  • who were scheduled to undergo surgery with spinal anesthetics
  • has no neurologic disorders that impair cooperation (e.g dementia)
  • has no true allergies to local anesthetics
  • has no contraindications for regional or neuraxial anesthesia (e.g bleeding diathesis, severe aortic stenosis)

You may not qualify if:

  • Childer under the age of 18
  • patients scheduled to undergo surgery with general anesthetics
  • refusing to participate
  • allergies to local anesthetics
  • any neurologic disorder that impairs patient cooperation
  • any contraindication to regional or neuraxial anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hip FracturesPain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

  • Onur OKUR

    Prof. Dr. Cemil Taşcıoğlu City Hospital

    PRINCIPAL INVESTIGATOR
  • Müslüm AKKILIC

    Prof. Dr. Cemil Taşcıoğlu City Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2022

First Posted

September 22, 2022

Study Start

September 20, 2022

Primary Completion

January 20, 2023

Study Completion

January 20, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations