Pericapsular Nerve Group Block for Total Hip Arthroplasty

NCT04295408 | Completed

• 1 other identifier: CE-IMKO 103/2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Arthropathy; Postoperative Pain

Keywords

hip arthoplasty; nerve block; analgesia

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  morphine consumption on mg

  day one

Secondary Outcomes (4)

• intraoperative opioid consumption

  Day 0

• Pain score after extubation

  up to 30 minutes

• postoperative pain score

  day one

• Pain score during seating position

  day one

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

Pericapsular Nerve Group block with 40 ml saline

Procedure: Pericapsular nerve group block with saline solution

Pericapsular nerve group block

EXPERIMENTAL

Pericapsular Nerve Group block with 2 mg.kg-1Ropivacaine in 40 ml of saline

Procedure: Pericapsular nerve group block with ropivacaine

Interventions

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.

PLACEBO

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

Pericapsular nerve group block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary THA with lateral approach under general anesthesia.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Institut Kassab D'Orthopedie

Tunis, 2010, Tunisia

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Saline Solution; Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• khaireddine Raddaoui, MD

  Tunis El Manar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: March 4, 2020
• Study Start: April 30, 2020
• Primary Completion: April 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

TU (1)