Pericapsular Nerve Group Block for Total Hip Arthroplasty

Efficacy of Pericapsular Nerve Group Block After Total Hip Arthroplasty Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Hip Arthropathy
• Intervention / Treatment: Procedure: Pericapsular nerve group block with saline solution; Procedure: Pericapsular nerve group block with ropivacaine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 2010
    • Institut Kassab D'Orthopedie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: PLACEBO; Pericapsular Nerve Group block with 40 ml saline	Procedure: Pericapsular nerve group block with saline solution; 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.
Experimental: Pericapsular nerve group block; Pericapsular Nerve Group block with 2 mg.kg-1Ropivacaine in 40 ml of saline	Procedure: Pericapsular nerve group block with ropivacaine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	morphine consumption on mg	day one

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative opioid consumption	total intraoperative fentanyl consumption on microg	Day 0
Pain score after extubation	simplified numerical score (SNS) after extubation [0=no pain , 10=worst pain].	up to 30 minutes
postoperative pain score	simplified numerical score (SNS) [0=no pain , 10=worst pain].	day one
Pain score during seating position	simplified numerical score (SNS) during seating position [0=no pain , 10=worst pain].	day one

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Investigators: Principal Investigator: khaireddine Raddaoui, MD, Tunis El Manar University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: nerve block; analgesia; hip arthoplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pain, Postoperative; Joint Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: CE-IMKO 103/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No