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

NCT05987254 | Completed

• 1 other identifier: RC 11-3-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Spinal Anesthesia; Hip Fractures

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• amount of tramadol used

  24 hours postoperatively

Study Arms (2)

FICB group

ACTIVE COMPARATOR

received ultrasound guided suprainguinal fascia iliaca block

Procedure: suprainguinal fascia iliaca block

PENG group

ACTIVE COMPARATOR

received ultrasound guided pericapsular nerve group block

Procedure: pericapsular nerve group block

Interventions

suprainguinal fascia iliaca block PROCEDURE

ultrasound guided suprainguinal fascia iliaca block

FICB group

pericapsular nerve group block PROCEDURE

ultrasound guided pericapsular nerve group block

PENG group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead
• Benha University: collaborator

Study Sites (3)

Haney Baumey

Banhā, 13518, Egypt

Location

Facualty of Pharmacy, Al Azhar University

Cairo, 11765, Egypt

Location

Neveen Kohaf

Tanta, 11865, Egypt

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: August 10, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (3)