Sonography-guided Pericapsular Never Group Block for Hip Arthroplasty (QUASH)

Sonography-guided Pericapsular Nerve Group Block for Hip Arthroplasty

In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG) block in hip arthroplasty as a post-operative pain management technique, study the analgesia, opioid-sparing effects and motor-blocking effects of the PENG block

Study Overview

• Status: Unknown
• Conditions: Analgesia; Arthroplasty; Nerve Block
• Intervention / Treatment: Procedure: pericapsular nerve group block

Detailed Description

PENG Block group (PG) will receive 0.5%Ropivacaine in 20 ml of saline. Sham Block group (SG) will receive 20 ml of saline Patient will be sedated with IV midazolam before nerve block. After peripheral nerve block ,general anesthesia will be conducted using sufentanyl, propofol and rocuronium for induction and propofol and sevoflurane for maintenance. Tests will be operated after procedure，and recorded up to 48 hours after surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Recruiting
      • Guangzhou First Municipal People's Hospital
      • Contact: Xiangcai Ruan, MD, PHD; Phone Number: 8620-81048306; Email: xc_ruan@hotmail.com
      • Contact: Jun Zheng, MD, Msc; Email: zhengjun19861029@126.com
      • Principal Investigator: Xiangcai Ruan, MD, PHD
      • Sub-Investigator: Jun Zheng, MD, Msc

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients scheduled for hip arthroplasty

Exclusion Criteria:

• allergy to local anesthetics
• infection at the injection site
• patients receiving opioids for chronic analgesic therapy
• other lower limb neuropathies
• inability to comprehend visual analog scale (VAS)
• preexist cognitive dysfunction

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: Pericapsular nerve group block	Procedure: pericapsular nerve group block; Branches of both the FN and ON provide innervation to the anterior hip capsule. High and low branches of FN provided the majority of innervation to the lateral and superomedial hip capsule. The AON innervates the medial capsule.Both of the nerve close to the periosteum between the iliopubic eminence and AIIS ,by using ultrasound guided technique,these sites can be potential bony landmarks provid approch to the nerve group.
Placebo Comparator: Saline placebo group	Procedure: pericapsular nerve group block; Branches of both the FN and ON provide innervation to the anterior hip capsule. High and low branches of FN provided the majority of innervation to the lateral and superomedial hip capsule. The AON innervates the medial capsule.Both of the nerve close to the periosteum between the iliopubic eminence and AIIS ,by using ultrasound guided technique,these sites can be potential bony landmarks provid approch to the nerve group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Highest VAS score in recovery room	Highest VAS score reported in recovery room,patient will be asked questions to measure the highest VAS score experienced in the recovery room before discharge. If the patient had a unexpected long stay at recovery room, the question will be asked at the time point "2 hours after surgery end"	before recovery room discharge(up to 2 hours after surgery end)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS at rest	VAS pain score while patient at rest	day0 ,day1 ,day2
highest VAS at period	highest VAS reported at follow up period	day0 ,day1 ,day2
quadriceps strength	Measure quadriceps strength peak value at different time point	day0 , day1 ,day2
total opioid consumption		up to 2 days after surgery
PONV rate	postoperative nausea and vomit	day0 ,day1 ,day2
Fall incident happened	Record the fall incident happened,fall is defined as patinent accidently fall to the ground.	up to 2 days after surgery
Nerve block range	A cotton yarn with ethanol will be put on both the surgical and nonsurgical leg to evaluate the cold sensation lost after nerve block.Skin sensation lost will be tested at lateral thigh,medial thigh,front thigh and lateral claf	day0 , before discharge from PACU(up to 2 hours after surgery end)

Collaborators and Investigators

• Sponsor: Guangzhou First People's Hospital

Publications and helpful links

General Publications

• Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6. Erratum In: Reg Anesth Pain Med. 2022 Jul;47(7):e4.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: PENG; Postoperative analgesia; hip arthroplasty; quadriceps strength; Pericapsular Nerve Group
• Other Study ID Numbers: K-2020-085-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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