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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04480320
Other study ID # K-2020-085-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 10, 2020
Est. completion date March 31, 2021

Study information

Verified date September 2020
Source Guangzhou First People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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 procedureļ¼Œand recorded up to 48 hours after surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 71
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Guangzhou First Municipal People's Hospital Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangzhou First People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 VAS at rest VAS pain score while patient at rest day0 ,day1 ,day2
Secondary highest VAS at period highest VAS reported at follow up period day0 ,day1 ,day2
Secondary quadriceps strength Measure quadriceps strength peak value at different time point day0 , day1 ,day2
Secondary total opioid consumption up to 2 days after surgery
Secondary PONV rate postoperative nausea and vomit day0 ,day1 ,day2
Secondary Fall incident happened Record the fall incident happened,fall is defined as patinent accidently fall to the ground. up to 2 days after surgery
Secondary 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)
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