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Completed

NCT Number: NCT04899388

Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block

assess and compare the efficacy of pericapsular nerve group block wersus lumber erector spinae plane block in reducing postoperative pain within the first 24 hours after hip surgeries.

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Key information

Conditions

Pericapsular Nerve Group Block (PENG Block) Lumbar Erector Spinae Plane Block

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aculty of Medicine,Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

About this study

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3groups each one containing 23 patients ,PENG group (n =23 ): The patients will receive Pericapsular Nerve Group Block (PENG Block) before positioning for spinal anesthesia.

ESPS group E (n =23 ): The patients will receive Lumbar Erector Spinae Plane Block before positioning for spinal anesthesia.

Control group C(n =23 ): patients received spinal anesthesia without any block.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Aged 65 to 75 years old. American Society of anesthesiologists physical status II and III. Body mass index of 25 to 30 kg/m2.

Exclusion criteria

Altered mental status. History of trauma or multiple fractures Uncontrolled hypertension and or diabetes. Coagulopathy. Preexisting advanced kidney, liver, or heart disease. Allergies or contraindications to the study drugs. Chronic use of opioids or corticosteroids.

Treatment and study plan

Pericapsular Nerve Block

Procedure

regional anaesthia

Other names: PENG

Lumbar Erector Spinae Plane Block

Procedure

regional anaesthia

Other names: LESB

Fentanyl

Drug

intavenous

Primary outcomes

  1. the time to first postoperative rescue analgesia

    Time frame: 24 hours postoperative

    the time to ask for the first postoperative analgesia (morphine) when the patient is reporting NRS ≥ 3

Secondary outcomes

  1. Block performance time (min)

    Time frame: immediately before surgery

    time from placement of ultrasound probe on the patient's skin to the end of local anesthetic injection

  2. onset of sensory block

    Time frame: after the block

    the time between the end of the injection of local anesthetic (bupivacaine) and the loss of pin prick sensation using a sterile 25G needle in the operating field.

  3. pain intensity

    Time frame: 30 minutes after the end of surgery ,3,6,12 hours postoperative.

    using an 11point numeric rating scale (NRS)(11) : 0: no pain,10=worst imaginable pain) 1-3Mild Pain (nagging, annoying, interfering little with activities of daily living (ADLs).

    4-6Moderate Pain (interferes significantly with activities of daily living(ADLs) 7-10Severe Pain (disabling; unable to perform ADLs) at rest and during movement (during45-degree passive flexion of the hip with the ipsilateral knee flexed)

  4. The total dose of rescue analgesia

    Time frame: 24 hours postoperative

    The total dose of rescue analgesia

  5. adverse effects

    Time frame: 24 hours postoperative

    nausea, vomiting ,hypotension ,bradycardia and hematoma

  6. Patient satisfaction

    Time frame: 24 hours postoperative

    related to block performance, post-operative pain relief was evaluated by an 11- point satisfaction score (0=unsatisfied and 10 = most satisfied), and the score was divided as follows 0-3 (not satisfied), 4-6 (partly satisfied), and 7-10 (highly satisfied).

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block as Postoperative Analgesia in Hip Surgeries: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 24, 2021
Registry last updated
Jun 26, 2023

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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