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Completed

NCT Number: NCT05549011

PENG vs SIFI Block for Positioning Pain During Spinal Anesthesia

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.

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Key information

Conditions

Hip Fractures Acute Post Operative Pain Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Nerve Block Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Spinal Anesthesia Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, 34384, Turkey (Türkiye)

About this study

Patients to whom an analgesic block was placed (either PENG or SIFI compartment analgesic block) to ameliorate positioning pain during spinal anesthesia for hip fracture surgery will be enrolled after written consent is obtained. Patients will be asked to report their pain intensity while sitting and their sitting angle will be measured. Patients will be observed for any possible complications( LAST, allergic reactions, hypotension, bradycardia). Pain intensity will then again be questioned postoperatively along with analgesic consumption at the 24th hour. Patients will be arranged into two cohorts according to the block (PENG vs SIFI) and the data obtained will be compared between two cohorts.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

PENG block

Other

PENG block for analgesic purposes performed before hip surgery

SIFI compartment block

Other

SIFI compartment block for analgesic purposes performed before hip surgery

Numeric Rating Scale

Diagnostic Test

Self-reported pain intensity score between 0-10

Angle of sitting

Diagnostic Test

Measurement of sitting angle in degrees with a protractor

Primary outcomes

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

    Time frame: 30 minutes after the block is placed

    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

Secondary outcomes

  1. Sitting angle during positioning

    Time frame: 30 minutes after the block is placed

    Angle of sitting in degrees measured with a protractor during sitting for spinal anesthesia

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

    Time frame: Postoperative day 1

    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

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

Comparison of the Effect of Pericapsular Nerve Group Block and Suprainguinal Fascia Iliaca Compartment Block for Preventing Positioning Pain During Spinal Anesthesia in Orthopedic Hip Surgery Patients: A Prospective Observational Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2022
Registry last updated
Mar 7, 2023

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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