Pericapsular Nerve Group Block for Elective Hip Arthroplasty

Pericapsular Nerve Group Block for Analgesia After Hip Arthroplasty: a Randomized Double-Blind, Placebo-Controlled Trial.

This study examine the effect of Pericapsular Nerve Group (PENG) Block on analgesia after elective hip arthroplasty. Half of participants will receive a PENG Block with local anesthetic, while the other half will receive a PENG Block with a placebo.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: PENG Block with local anesthetic; Procedure: PENG Block with 0,9% saline

Detailed Description

Optimized analgesia is crucial for early mobilization after hip arthroplasty. Regional anesthesia, like fascia iliaca block or femoral nerve block, have limited indication because of motor blockade whereas local infiltrations analgesia have shown conflicting analgesic efficacy results in hip arthroplasty.

Pericapsular nerve group (PENG) block is a new regional anesthesia technique targeting specifically sensory nerve branches of the hip articulation. It has been originally described in hip fracture patients.

The aim of this study is to evaluate the efficacy of PENG block on analgesia after elective hip arthroplasty.

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

Contacts and Locations

• Study Contact: Name: Nicolas Van Rompaey, MD; Phone Number: +3264276111; Email: nvrompae@chu-tivoli.be

Study Locations

• Belgium
  • La Louviere, Belgium, 7100
    • Recruiting
    • CHU Tivoli
    • Contact: Nicolas Van Rompaey, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective total hip arthroplasty
• General anesthesia
• Enhanced Recovery Program

Exclusion Criteria:

• American Society of Anesthesiologists (ASA) Score > 2
• Drug allergy
• Significant psychiatric disturbances
• Preoperative opioid use
• Contraindication to acetaminophen, celecoxib, methylprednisolone or tranexamic acid
• Body Mass Index > 40 kg/m²

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PENG group; PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine	Procedure: PENG Block with local anesthetic; After induction of general anesthesia, PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.
Placebo Comparator: Placebo group; PENG block with 20 ml of 0,9% saline	Procedure: PENG Block with 0,9% saline; After induction of general anesthesia, PENG block with 20 ml of 0,9% saline will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score on first Mobilization	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on first mobilization at day 0 after surgery	Postoperative time until midnight day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Pain Score in Post-Anaesthesia Care Unit	Maximum Pain score evaluated in Post Anesthesia Care Unit by a a visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])	Through postoperative time during Post Anesthesia Care Unit stay at day 0
Morphine Consumption at Day 0	Total of Piritramid, Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 0	Postoperative time until midnight day 0
Piritramid Consumption	Total of Piritramid use from the end of surgery until Post Anesthesia Care Unit discharge to the ward	Through the end of surgery until Post Anesthesia Care Unit discharge to the ward at day 0
Morphine Consumption at Day 1	Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 1	Postoperative time during Post Anesthesia Care Unit stay at day 0
Morphine Consumption at Day 2	Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 2	Postoperative time until midnight day 2
Pain Score at Rest 2h Postop	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 2h after surgery	2 hours after surgery
Pain Score on mobilization 2h Postop	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 2h after surgery	2 hours after surgery
Pain Score at Rest 4h Postop	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 4h after surgery	4 hours after surgery
Pain Score on mobilization 4h Postop	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 4h after surgery	4 hours after surgery
Pain Score at Rest 6h Postop	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 6h after surgery	6 hours after surgery
Pain Score on mobilization 6h Postop	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 6h after surgery	6 hours after surgery
Pain Score at Rest Day 1 AM	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the morning of day 1	Day 1 in the morning after surgery
Pain Score on mobilization Day 1 AM	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the morning of day 1	Day 1 in the morning after surgery
Pain Score at Rest Day 1 PM	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the afternoon of day 1	Day 1 in the afternoon after surgery
Pain Score on mobilization Day 1 PM	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the afternoon of day 1	Day 1 in the afternoon after surgery
Pain Score at Rest Day 2 AM	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the morning of day 2	Day 2 in the morning after surgery
Pain Score on mobilization Day 2 AM	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the morning of day 2	Day 2 in the morning after surgery
Pain Score at Rest Day 2 PM	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the afternoon of day 2	Day 2 in the afternoon after surgery
Pain Score on mobilization Day 2 PM	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the afternoon of day 2	Day 2 in the afternoon after surgery
First Mobilization Success	Success rate of patients mobilized the day of surgery	Postoperative time until midnight day 0
Mean remifentanil Infusion Rate	Total infused remifentanil dose per kg body weight per minute of total operative time	Intraoperatively
Quadriceps weakness	Evaluation of quadriceps motricity by Neal test which consist in supporting the knee under the popliteal fossa and asking the patient to extend the knee against resistance.	Through postoperative time during Post Anesthesia Care Unit stay at day 0

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction after 24h	Patient satisfaction for the first 24h after surgery recorded with a scale from 0 (unsatisfied) to 10 (extremely satisfied).	24 hours after surgery
Length of hospital stay	Calculated as the number of days between the hospital admission and discharge dates.	During hospital stay, up to 1 week
PACU stay	Time from the arrival in Post Anesthesia Care Unit until discharge to the ward	Postoperative time during Post Anesthesia Care Unit stay at day 0
Postoperative Nausea and Vomiting	The incidence and severity of postoperative nausea (none=0, mild=1, moderate=2, severe=3), episodes of vomiting, and need for rescue antiemetics was also documented.	PACU, at 2, 6, 24, and 48 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Tivoli
• Investigators: Principal Investigator: Nicolas Van Rompaey, MD, CHU Tivoli

Publications and helpful links

General Publications

• Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 15, 2022

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Elective Hip Surgery; PENG Block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: P2019/482; 2019-001956-21 (EudraCT Number)

Drug and device information, study documents

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