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

Sponsor

Al-Azhar University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05987254

Collaborator

Benha University (Other)

Enrollment

Locations

Arms

2.7

Anticipated Duration (Months)

Patients Per Site

11.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Anesthesia Hip Fractures	Procedure: suprainguinal fascia iliaca block Procedure: pericapsular nerve group block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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.

Anticipated Study Start Date :

Aug 10, 2023

Anticipated Primary Completion Date :

Oct 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

NRS [30 minute postoperative]
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'.

Secondary Outcome Measures

amount of tramadol used [24 hours postoperatively]
number of rescue doses of tramadol will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haney Baumey	Banhā		Egypt	13518
2	Facualty of Pharmacy, Al Azhar University	Cairo		Egypt	11765

Sponsors and Collaborators

Al-Azhar University
Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neveen Abd El Maksoad Kohaf, Lecturer of Clinical Pharmacy, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05987254

Other Study ID Numbers:

RC 11-3-2023

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fractures, Bone

Hip Fractures

Study Results

No Results Posted as of Aug 14, 2023