ArthroplastyQUASHNCT04480320
Sonography-guided Pericapsular Never Group Block for Hip Arthroplasty
A study testing pericapsular nerve group block in people with Arthroplasty and Nerve Block, run by Guangzhou First People's Hospital at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Nerve Block, Analgesia
- What is being tested?
- pericapsular nerve group block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for hip arthroplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, 510180
Xiangcai Ruan, MD, PHD, 8620-81048306, xc_ruan@hotmail.com
Jun Zheng, MD, Msc, zhengjun19861029@126.com
About this study
Official title: 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
Read the 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.
- Conditions
- Arthroplasty, Nerve Block, Analgesia
- Being tested
- pericapsular nerve group block
- Keywords
- Pericapsular Nerve Group, PENG, hip arthroplasty, Postoperative analgesia, quadriceps strength
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pericapsular nerve group blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pericapsular nerve group block | Experimental | Not described Receives: Procedure: pericapsular nerve group block |
| Saline placebo group | Placebo comparator | Not described Receives: Procedure: pericapsular nerve group block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: before recovery room discharge(up to 2 hours after surgery end)
Secondary outcomes (7)
VAS at rest
VAS pain score while patient at rest
Measured: day0 ,day1 ,day2
highest VAS at period
highest VAS reported at follow up period
Measured: day0 ,day1 ,day2
quadriceps strength
Measure quadriceps strength peak value at different time point
Measured: day0 , day1 ,day2
total opioid consumption
Measured: up to 2 days after surgery
PONV rate
postoperative nausea and vomit
Measured: day0 ,day1 ,day2
Fall incident happened
Record the fall incident happened,fall is defined as patinent accidently fall to the ground.
Measured: 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
Measured: day0 , before discharge from PACU(up to 2 hours after surgery end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start10 Sep 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Guangzhou First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480320
- Sponsor's protocol ID
- K-2020-085-01
- Acronym
- QUASH
- Status last verified
- Sep 2020
- First submitted
- 2 Jul 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34873023
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonography-guided Pericapsular Nerve Group Block for Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04480320
- Acronym / sponsor ID
- QUASH / K-2020-085-01
- Conditions
- Arthroplasty, Nerve Block, Analgesia
- Keywords
- Pericapsular Nerve Group, PENG, hip arthroplasty, Postoperative analgesia, quadriceps strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pericapsular nerve group block | Experimental | Procedure: pericapsular nerve group block |
| Saline placebo group | Placebo comparator | Procedure: pericapsular nerve group block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for hip arthroplasty
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pericapsular nerve group blockBranches 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. | Procedure or surgery | Pericapsular nerve group block, Saline placebo group |
Primary outcome
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"
7 secondary outcomes
VAS at rest
Time frame: day0 ,day1 ,day2
highest VAS at period
Time frame: day0 ,day1 ,day2
quadriceps strength
Time frame: day0 , day1 ,day2
total opioid consumption
Time frame: up to 2 days after surgery
PONV rate
Time frame: day0 ,day1 ,day2
Fall incident happened
Time frame: up to 2 days after surgery
Nerve block range
Time frame: day0 , before discharge from PACU(up to 2 hours after surgery end)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Derived from this study: PubMed 34873023Zheng 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pericapsular nerve group block in people with Arthroplasty and Nerve Block, run by Guangzhou First People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highest VAS score in recovery room (time frame: before recovery room discharge(up to 2 hours after surgery end)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04480320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.