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OpenTrials
Completed

NCT Number: NCT05796804

Erector Spinae Block Versus PENG Block for Hip Replacement

THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Erector Spinae Plane Block (ESPB) and PENG (pericapsular nerve group block) are alternative approaches to the hip sensitive nerve branches that resulted to be very promising for hip surgeries. However, no studies investigated the analgesic superiority of either PENG or ESPB. In our study the investigators compare PENG (with a lateral femoral cutaneous nerve block) and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aast Papa Giovanni Xxiii

Bergamo, 24127, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • primary total hip replacement
  • informed consent

Exclusion criteria

  • allergies to study drugs
  • spinal anesthesia contraindicated
  • kidney failure
  • epilepsy, psychiatric disease, neurologic deficits
  • revision surgery
  • neuropathies in the lumbar area
  • no informed consent
  • pregnancy
  • alcohol/opioid abuse
  • emergency surgery/intensive care

Treatment and study plan

Erector Spinae Plane Block

Procedure

ULTRASOUND GUIDED - ROPIVACAINE 30 ml 0.5%

Peng block + lateral femoral cutaneous nerve block

Procedure

ULTRASOUND GUIDED - ROPIVACAINE 20 ml 0.5% + 10 ml 0.5%

Spinal anesthesia

Procedure

bupivacaine 0.5% 2.2 ml

Primary outcomes

  1. morphine consumption

    Time frame: 24 hours

    milligrams of morphine by patient controlled analgesia intravenously

Secondary outcomes

  1. postoperative pain

    Time frame: 48 hours

    numeric rating scale - NRS 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

  2. neuropathic pain

    Time frame: 48 hours

    DN4 questionnaire - 4 items questionnaire to investigate the occurrence of neuropathic component

  3. postoperative complications

    Time frame: 48 hours

    nausea, vomiting, vertigo, blurred vision, syncope, bleeding, falls

  4. chronic postoperative pain

    Time frame: 3 months

    numeric rating scale 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

Sponsors and collaborators

Lead sponsor

Papa Giovanni XXIII Hospital

Other

Registry information

Official study title

Erector Spinae Block Versus PENG Block for Postoperative Analgesia After Total Hip Replacement

Acronym: PENGESP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 4, 2023
Registry last updated
Jul 30, 2024

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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