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

September 10, 2020 updated by: Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Guangzhou First People's Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • Guangzhou First Municipal People's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiangcai Ruan, MD, PHD
        • Sub-Investigator:
          • Jun Zheng, MD, Msc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Highest VAS score in recovery room
Time Frame: before recovery room discharge(up to 2 hours after surgery end)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VAS at rest
Time Frame: day0 ,day1 ,day2
VAS pain score while patient at rest
day0 ,day1 ,day2
highest VAS at period
Time Frame: day0 ,day1 ,day2
highest VAS reported at follow up period
day0 ,day1 ,day2
quadriceps strength
Time Frame: day0 , day1 ,day2
Measure quadriceps strength peak value at different time point
day0 , day1 ,day2
total opioid consumption
Time Frame: up to 2 days after surgery
up to 2 days after surgery
PONV rate
Time Frame: day0 ,day1 ,day2
postoperative nausea and vomit
day0 ,day1 ,day2
Fall incident happened
Time Frame: up to 2 days after surgery
Record the fall incident happened,fall is defined as patinent accidently fall to the ground.
up to 2 days after surgery
Nerve block range
Time Frame: day0 , before discharge from PACU(up to 2 hours after surgery end)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou First People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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