Clinical trial NCT04231123: Pericapsular Nerve Group Block for Elective Hip Arthroplasty
Official title: Pericapsular Nerve Group Block for Analgesia After Hip Arthroplasty: a Randomized Double-Blind, Placebo-Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: Elective Hip Surgery
PENG Block
Lead sponsor: Centre Hospitalier Universitaire de Tivoli
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Score on first Mobilization
timeFrame: Postoperative time until midnight day 0
Secondary outcomes:
measure: Maximum Pain Score in Post-Anaesthesia Care Unit
timeFrame: Through postoperative time during Post Anesthesia Care Unit stay at day 0
measure: Morphine Consumption at Day 0
timeFrame: Postoperative time until midnight day 0
measure: Piritramid Consumption
timeFrame: Through the end of surgery until Post Anesthesia Care Unit discharge to the ward at day 0
measure: Morphine Consumption at Day 1
timeFrame: Postoperative time during Post Anesthesia Care Unit stay at day 0
measure: Morphine Consumption at Day 2
timeFrame: Postoperative time until midnight day 2
measure: Pain Score at Rest 2h Postop
timeFrame: 2 hours after surgery
measure: Pain Score on mobilization 2h Postop
timeFrame: 2 hours after surgery
measure: Pain Score at Rest 4h Postop
timeFrame: 4 hours after surgery
measure: Pain Score on mobilization 4h Postop
timeFrame: 4 hours after surgery
measure: Pain Score at Rest 6h Postop
timeFrame: 6 hours after surgery
measure: Pain Score on mobilization 6h Postop
timeFrame: 6 hours after surgery
measure: Pain Score at Rest Day 1 AM
timeFrame: Day 1 in the morning after surgery
measure: Pain Score on mobilization Day 1 AM
timeFrame: Day 1 in the morning after surgery
measure: Pain Score at Rest Day 1 PM
timeFrame: Day 1 in the afternoon after surgery
measure: Pain Score on mobilization Day 1 PM
timeFrame: Day 1 in the afternoon after surgery
measure: Pain Score at Rest Day 2 AM
timeFrame: Day 2 in the morning after surgery
measure: Pain Score on mobilization Day 2 AM
timeFrame: Day 2 in the morning after surgery
measure: Pain Score at Rest Day 2 PM
timeFrame: Day 2 in the afternoon after surgery
measure: Pain Score on mobilization Day 2 PM
timeFrame: Day 2 in the afternoon after surgery
measure: First Mobilization Success
timeFrame: Postoperative time until midnight day 0
measure: Mean remifentanil Infusion Rate
timeFrame: Intraoperatively
measure: Quadriceps weakness
timeFrame: Through postoperative time during Post Anesthesia Care Unit stay at day 0
Other outcomes:
measure: Patient satisfaction after 24h
timeFrame: 24 hours after surgery
measure: Length of hospital stay
timeFrame: During hospital stay, up to 1 week
measure: PACU stay
timeFrame: Postoperative time during Post Anesthesia Care Unit stay at day 0
measure: Postoperative Nausea and Vomiting
timeFrame: PACU, at 2, 6, 24, and 48 hours
Locations:
city: La Louviere
country: Belgium
facility: Chu Tivoli
Study officials:
affiliation: Centre Hospitalier Universitaire de Tivoli
name: Nicolas Van Rompaey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.