Pericapsular Nerve Group Block for Elective Hip Arthroplasty

Not Applicable

• Conditions: Postoperative Pain

• Registration Number: NCT04231123
• Lead Sponsor: Centre Hospitalier Universitaire de Tivoli

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.

Study Timeline

• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Study Start: 2020-01-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Score on first Mobilization	Postoperative time until midnight day 0	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

Secondary Outcome Measures

Name	Time	Method
Piritramid Consumption	Through the end of surgery until Post Anesthesia Care Unit discharge to the ward at day 0	Total of Piritramid use from the end of surgery until Post Anesthesia Care Unit discharge to the ward
Pain Score on mobilization Day 1 AM	Day 1 in the morning after surgery	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
Pain Score at Rest Day 2 AM	Day 2 in the morning after surgery	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
Pain Score on mobilization Day 2 AM	Day 2 in the morning after surgery	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
Pain Score on mobilization Day 2 PM	Day 2 in the afternoon after surgery	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
Morphine Consumption at Day 1	Postoperative time during Post Anesthesia Care Unit stay at day 0	Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 1
Morphine Consumption at Day 2	Postoperative time until midnight day 2	Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 2
Maximum Pain Score in Post-Anaesthesia Care Unit	Through postoperative time during Post Anesthesia Care Unit stay at day 0	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 \[100-mm scale\])
Pain Score at Rest 6h Postop	6 hours after surgery	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
Pain Score on mobilization Day 1 PM	Day 1 in the afternoon after surgery	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
First Mobilization Success	Postoperative time until midnight day 0	Success rate of patients mobilized the day of surgery
Mean remifentanil Infusion Rate	Intraoperatively	Total infused remifentanil dose per kg body weight per minute of total operative time
Quadriceps weakness	Through postoperative time during Post Anesthesia Care Unit stay at day 0	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.
Morphine Consumption at Day 0	Postoperative time until midnight day 0	Total of Piritramid, Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 0
Pain Score at Rest 2h Postop	2 hours after surgery	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
Pain Score at Rest 4h Postop	4 hours after surgery	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
Pain Score on mobilization 4h Postop	4 hours after surgery	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
Pain Score at Rest Day 1 AM	Day 1 in the morning after surgery	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
Pain Score on mobilization 2h Postop	2 hours after surgery	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
Pain Score on mobilization 6h Postop	6 hours after surgery	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
Pain Score at Rest Day 1 PM	Day 1 in the afternoon after surgery	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
Pain Score at Rest Day 2 PM	Day 2 in the afternoon after surgery	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

Trial Locations

Locations (1)

Chu Tivoli; 🇧🇪 La Louviere, Belgium