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Completed

NCT Number: NCT05256056

Volume Dependent Effect of Pericapsular Nerve Block

In PENG block technique, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves which innervates the hip capsule for providing analgesia without causing muscle weakness. Since the PENG block is a facial plane block, it causes a volume dependent distribution. There are a few case reposts and cadaveric studies on volume dependent effect of analgesia and motor weakness of PENG block.

In our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of PENG block.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sisli Etfal Research and Training Hospital

Seyrantepe, Istanbul, 34567, Turkey (Türkiye)

About this study

Femur fracture is the one of the most common case groups and it is seen mostly in the elderly patient population with comorbidities. For these patients, perioperative, postoperative analgesia and early mobilization are important to reduce cardiopulmonary complications and morbidity. Femoral fracture operations are mostly performed under spinal anesthesia especially under unilateral spinal anesthesia to sustain more stable hemodynamics. The lateral decubitus position, which is used for unilateral spinal anesthesia, is a painful position for these patients. Intravenous opioids are used for this procedure, however they have possible side-effects, such as sedation, inhibition of respiratory, lower blood pressure. Because of these reasons, pericapsular nerve block (PENG) has been applied recently to avoid complications. By using PENG block , positioning for spinal anesthesia is easier for patients and anesthesiologists, and postoperative analgesia can be provided.

By PENG block, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves innervating the hip capsule, thus providing analgesia in patients, but muscle weakness is not expected. Becacuse PENG block is a facial plane block, it shows a volume dependent distribution. There are a few case reposts and cadaveric studies, which are showing volume depend effect of analgesia and motor weakness of PENG block.

In our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of PENG block.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who will undergoing hip arthroplasty surgery
  • Patients over the age of 18
  • ASA I-II-III patients
  • Patients who will be operated under spinal anesthesia

Exclusion criteria

  • ASA IV patients, Pregnant women
  • Patients who are not suitable for spinal anesthesia
  • Patients diagnosed with Alzheimer's and dementia who cannot cooperate
  • Patients who are not suitable for peripheral nerve block (patients with infection in the injection area, with local anesthetic allergy, with coagulopathy)
  • Patients who do not want to participate in the study
  • Patients under the age of 18
  • Patients switched to general anesthesia

Treatment and study plan

Bupivacain

Drug

efficacy of bupivacaine in different volumes

Primary outcomes

  1. visual analouge scale

    Time frame: up to 24 hours,

    the VAS 0 means no pain, 10 means the worst pain possible

  2. pin-prick test

    Time frame: up to 20 minutes

    the ability to determine the difference between sharp and dull.

Secondary outcomes

  1. cold sensation test

    Time frame: up to 20 minutes

    feel the cold: 0, not feel : 1

  2. presence of quadriceps motor block

    Time frame: up to 24 hours

    Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

Comparison of the Volume Dependent Effect of Pericapsular Nerve Block in Patients Operated for Femur Fracture: A Randomized Prospective Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2022
Registry last updated
Jun 3, 2022

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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