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Clinical Trials/NCT06577103
NCT06577103
Completed
N/A

A Comparative Study Between the Analgesic Effect of Pericapsular Nerve Group Block (PENG) With Lateral Femoral Cutaneous Nerve Block (LFCN) and Pericapsular Nerve Group Block (PENG) With Supra-inguinal Fascia Iliaca Block (SIFIC) in Hip Hemiarthroplasty: a Prospective Randomized Clinical Trial

Ain Shams University1 site in 1 country60 target enrollmentJanuary 2, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pericapsular Nerve Group Block
Sponsor
Ain Shams University
Enrollment
60
Locations
1
Primary Endpoint
Degree of pain
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this study is to investigate the efficiency of preoperative and post-operative analgesia by pericapsular nerve group block (PENG) block with supra-inguinal fascia iliaca block (SIFIC) block compared with PENG block with lateral femoral cutaneous nerve block (LFCN) block in ease of giving a sitting position for spinal anesthesia and reducing narcotic consumption during the first 24 hour post-operatively and functional recovary by using the Visual analogue scale (VAS) of pain.

Detailed Description

The established practice to decrease pain using opioids in hip fracture surgery may result in compromised outcomes in the frail and elderly population with nausea-vomiting, constipation, delirium and respiratory depression. This popularized the regional analgesic techniques in the surgical treatment of hip fractures. Femoral nerve (FN) and supra-inguinal fascia iliaca block (SIFIC) block are documented to provide good peri-operative analgesia with reduced need for opioids. The latest pericapsular nerve group block (PENG) block, is an interfacial plane block targeting the articular branches of the femoral, obturator (ON) and accessory obturator nerves (AON) at the hip. An ability to perform in supine positioning, which is especially important in patients with acute hip fractures or chronic pain is an indigenous advantage of PENG block. Due to the blockade of only sensory articular branches, substantial motor weakness is unexpected. But exclusive use of PENG block for analgesia in hip fracture patients is not sufficient as it doesn't involve the cutaneous pain-generating area supplied by the lateral femoral cutaneous nerve block (LFCN).

Registry
clinicaltrials.gov
Start Date
January 2, 2024
End Date
December 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Moussa Elsayed

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Ain Shams University,Egypt

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Age 40-80 years.
  • Sex: Both sexes.
  • American Society of Anaesthesiologists (ASA) Physical Status Class I, II, and III.
  • Scheduled for hip hemiarthroplasty under general anesthesia.

Exclusion Criteria

  • Declining to give a written informed consent.
  • History of allergy to the medications used in the study.
  • Contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection).
  • Psychiatric disorders or narcotic abusers.
  • Significant cognitive dysfunction.
  • American Society of Anesthesiologists (ASA) Physical Status Class IV.
  • Renal insufficiency (to avoid local anesthetic or nalbuphine metabolites adverse effect)
  • Opioid abuser patients
  • Pregnancy.

Outcomes

Primary Outcomes

Degree of pain

Time Frame: 24 hours postoperatively

Degree of pain will be assessed by visual analogue score (VAS). VAS ranging from 0 to 10, where 0 is no pain and 10 is maximum pain. It will be assessed preoperatively first after the block application then postoperatively, at post anesthesia care unit (PACU) and then 2, 6 ,12 ,18 ,24 hours postoperatively.

Secondary Outcomes

  • Ablility to walk with support within 24 hours(24 hours postoperatively)
  • The total dose of nalbuphine consumption(24 hours postoperatively)
  • The number of patients who needed rescue analgesia(24 hours postoperatively)
  • The ease of giving a sitting position for spinal anesthesia (EOSP)(Intraoperatively)

Study Sites (1)

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