Peri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients

Comparison Between Peri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients: A Randomized Clinical Trial.

Severe pain associated with fractured hip often results in difficulty during positioning for spinal anesthesia (SA). Among many regional analgesic techniques, the fascia iliaca compartment block (FICB) is popular among anesthesiologists to provide immediate as well as postoperative analgesia in hip fractures. Recently, the pericapsular nerve group (PENG) block has been proposed to provide effective analgesia in hip fracture patients. However, comparative studies between PENG and FICB are lacking.

Study Overview

• Status: Completed
• Conditions: Hip Fractures; Spinal Anesthesia
• Intervention / Treatment: Procedure: suprainguinal fascia iliaca block; Procedure: pericapsular nerve group block

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banhā, Egypt, 13518
    • Haney Baumey
  • Cairo, Egypt, 11765
    • Facualty of Pharmacy, Al Azhar University
  • Tanta, Egypt, 11865
    • Neveen Kohaf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 40 years and above with hip fracture with persistent pain and scheduled for surgery under spinal anesthesia (SA)

Exclusion Criteria:

• any contraindications to SA or peripheral nerve blocks, history of ischaemic heart disease, patients on opioids for chronic pain and patients with significant cognitive impairment. Patients who had no pain while sitting by themselves (resting pain less than 4 on NRS) for SA without any support were also excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FICB group; received ultrasound guided suprainguinal fascia iliaca block	Procedure: suprainguinal fascia iliaca block; ultrasound guided suprainguinal fascia iliaca block
Active Comparator: PENG group; received ultrasound guided pericapsular nerve group block	Procedure: pericapsular nerve group block; ultrasound guided pericapsular nerve group block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS	In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.	30 minute postoperative
The ease of spinal positioning (EOSP)	The ease of spinal positioning (EOSP) was assessed on the scale of 0-3 (0 = unable to position, 1 = patient had abnormal posturing due to pain and required support for positioning, 2 = mild discomfort but does not require support for positioning, 3 = optimal condition where the patient was able to position himself without pain)	Thirty minutes after the blocks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of tramadol used	number of rescue doses of tramadol will be recorded	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Collaborators: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: RC 11-3-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: data will be shared upon resealable request from the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No