PENG vs SIFI Block for Positioning Pain During Spinal Anesthesia

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05549011
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 13

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures; Acute Post Operative Pain; Nerve Block; Spinal Anesthesia	Other: PENG Block; Other: SIFI compartment block; Diagnostic Test: Numeric Rating Scale; Diagnostic Test: Angle of sitting

Detailed Description

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 52 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official 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
• Anticipated Study Start Date: Sep 20, 2022
• Anticipated Primary Completion Date: Jan 20, 2023
• Anticipated Study Completion Date: Jan 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
PENG block This cohort will include participants to whom a PENG block is performed before positioning for spinal anesthesia	Other: PENG Block; PENG block for analgesic purposes performed before hip surgery; Diagnostic Test: Numeric Rating Scale; Self-reported pain intensity score between 0-10; Diagnostic Test: Angle of sitting; Measurement of sitting angle in degrees with a protractor
SIFI block This cohort will include participants to whom a SIFI compartment block is performed before positioning for spinal anesthesia	Other: SIFI compartment block; SIFI compartment block for analgesic purposes performed before hip surgery; Diagnostic Test: Numeric Rating Scale; Self-reported pain intensity score between 0-10; Diagnostic Test: Angle of sitting; Measurement of sitting angle in degrees with a protractor

Outcome Measures

Primary Outcome Measures

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

1. Sitting angle during positioning [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) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prof. Dr. Cemil Taşcıoğlu City Hospital	Istanbul		Turkey	34384

Sponsors and Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

• Principal Investigator: Onur OKUR, Prof. Dr. Cemil Taşcıoğlu City Hospital
• Study Director: Müslüm AKKILIC, Prof. Dr. Cemil Taşcıoğlu City Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Onur Okur, Principal Investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
• ClinicalTrials.gov Identifier: NCT05549011
• Other Study ID Numbers: 326
• First Posted: Sep 22, 2022
• Last Update Posted: Sep 22, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Hip Fractures

Study Results

No Results Posted as of Sep 22, 2022