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NCT Number: NCT06577103

The Analgesic Effect of Pericapsular Nerve Group Block With Lateral Femoral Cutaneous Nerve Block and Pericapsular Nerve Group Block With Supra-inguinal Fascia Iliaca Block in Hip Hemiarthroplasty

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.

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Key information

Conditions

Pericapsular Nerve Group Block Hip Hemiarthroplasty Lateral Femoral Cutaneous Nerve Block Supra-inguinal Fascia Iliaca Block

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Cairo Governorate, 11591, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC)

Other

Patients will receive pericapsular nerve group (PENG) block with supra-inguinal fascia iliaca (SIFIC) block.

Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN)

Other

Patients will receive pericapsular nerve group (PENG) block with lateral femoral cutaneous nerve (LFCN) block.

Primary outcomes

  1. 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

  1. The ease of giving a sitting position for spinal anesthesia (EOSP)

    Time frame: Intraoperatively

    The ease of giving a sitting position for spinal anesthesia (EOSP) will be assessed by the EOSP score .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

  2. The total dose of nalbuphine consumption

    Time frame: 24 hours postoperatively

    When visual analogue score (VAS) >/=4, patients will receive injection nalbuphine 10 mg/70 kg (with maximum dose 160 mg over 24 hours) intravenously.

  3. The number of patients who needed rescue analgesia

    Time frame: 24 hours postoperatively

    Number of patients who needed rescue analgesia will be recorded

  4. Ablility to walk with support within 24 hours

    Time frame: 24 hours postoperatively

    The ability of patients to walk with support will be recorded

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2024
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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