Pericapsular Nerve Group Block for Elective Hip Arthroplasty

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04231123
• Other study ID #: P2019/482
• Secondary ID: 2019-001956-21
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: March 15, 2022

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de Tivoli
• Contact: Nicolas Van Rompaey, MD
• Phone: +3264276111
• Email: nvrompae[@]chu-tivoli.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 15, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Chu Tivoli	La Louviere

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Tivoli

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Girón-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Length of hospital stay	Calculated as the number of days between the hospital admission and discharge dates.	During hospital stay, up to 1 week
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	First Mobilization Success	Success rate of patients mobilized the day of surgery	Postoperative time until midnight day 0
Secondary	Mean remifentanil Infusion Rate	Total infused remifentanil dose per kg body weight per minute of total operative time	Intraoperatively
Secondary	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