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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05987254
Other study ID # RC 11-3-2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 10, 2023
Est. completion date March 30, 2024

Study information

Verified date February 2024
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
suprainguinal fascia iliaca block
ultrasound guided suprainguinal fascia iliaca block
pericapsular nerve group block
ultrasound guided pericapsular nerve group block

Locations

Country Name City State
Egypt Haney Baumey Banha
Egypt Facualty of Pharmacy, Al Azhar University Cairo
Egypt Neveen Kohaf Tanta

Sponsors (2)

Lead Sponsor Collaborator
Al-Azhar University Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 amount of tramadol used number of rescue doses of tramadol will be recorded 24 hours postoperatively
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