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Completed

NCT Number: NCT04295408

Pericapsular Nerve Group Block for Total Hip Arthroplasty

Controlling pain after hip replacement surgery improves comfort and partient satisfaction. Pain after hip replacement has traditionally been managed using systemic pain medications including acetaminophen and non-steroidal anti-inflammatory drugs. A recent Cochrane review demonstrated that compared to systemic analgesia alone, peripheral nerve blocks reduce postoperative pain with moderate-quality evidence. Pericapsular Nerve Group block is a new technique allowing local anesthetic diffusion to femoral, obturator and accessory obturator nerves and providing a good analgesic effect for hip fracture surgery. Investigators hypothesized that the PENG block could be an interesting alternative to systemic analgesiscs for pain control after total hip replacement.

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Key information

Conditions

Hip Arthropathy Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Kassab D'Orthopedie

Tunis, 2010, Tunisia

About this study

The aim of the study was to evaluate the efficacy of the PENG block for intra and postoperative pain control in total hip arthroplasty.

it was a monocentric, randomized, controlled and double blind study. Patients scheduled for primary THA with lateral approach under general anesthesia.

Premedication with IV midazolam 1 to 2 mg on arrival to operating theatre. general anesthesia was conducted using fentanyl, propofol and cisatracurium for induction and isoflurane for maintanance patients were randomized using a random table in two groups:

  • PENG Block group (PG) who received 2 mg.kg-1Ropivacaine in 40 ml of saline.
  • Placebo group (SG) who received 40 ml of saline.

Postoperative analgesia started before extubation of the patient, with:

  • IV paracetamol 1g/6h in Day1 and oral paracetamol 1g/8h for 6 days.
  • non steroidal anti inflammatory drugs with IM piroxicam 20 mg on day one (at the end of surgery) and oral diclofenac 50 mg/12h for 3 days.
  • Morphine PCA for day 1 (24 H) and oral tramadol 50 mg/12h from day 2 to day 6.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • primary THA with lateral approach under general anesthesia.

Exclusion criteria

  • Hip fracture,
  • allergy to local anesthetics,
  • peripheral neuropathy,
  • creatinin clearance inferior to 30ml/min,
  • weight inferior to 50 Kg or superior to 100 Kg,
  • neurological disorder affecting the lower extremity, significant psychiatric conditions,
  • patients receiving corticosteroid therapy,
  • chronic consumption of opioids (>2 months).

Treatment and study plan

Pericapsular nerve group block with saline solution

Procedure

A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the saline solution was injected in 5-mL increments while observing for adequate fluid spread in this plane.a total volune of 40 ml saline solution was injected.

Pericapsular nerve group block with ropivacaine

Procedure

A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, local anesthetic was injected in 5-mL increments while observing for adequate fluid spread in this plane. a 2 mg.kg-1Ropivacaine in 40 ml of saline was injected

Primary outcomes

  1. Total morphine consumption

    Time frame: day one

    morphine consumption on mg

Secondary outcomes

  1. intraoperative opioid consumption

    Time frame: Day 0

    total intraoperative fentanyl consumption on microg

  2. Pain score after extubation

    Time frame: up to 30 minutes

    simplified numerical score (SNS) after extubation [0=no pain , 10=worst pain].

  3. postoperative pain score

    Time frame: day one

    simplified numerical score (SNS) [0=no pain , 10=worst pain].

  4. Pain score during seating position

    Time frame: day one

    simplified numerical score (SNS) during seating position [0=no pain , 10=worst pain].

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

Efficacy of Pericapsular Nerve Group Block After Total Hip Arthroplasty Surgery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2020
Registry last updated
Feb 13, 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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