NCT04480320

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

July 2, 2020

Last Update Submit

September 10, 2020

Conditions

Keywords

Pericapsular Nerve GroupPENGhip arthroplastyPostoperative analgesiaquadriceps strength

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • VAS at rest

    day0 ,day1 ,day2

  • highest VAS at period

    day0 ,day1 ,day2

  • quadriceps strength

    day0 , day1 ,day2

  • total opioid consumption

    up to 2 days after surgery

  • PONV rate

    day0 ,day1 ,day2

  • +2 more secondary outcomes

Study Arms (2)

Pericapsular nerve group block

EXPERIMENTAL
Procedure: pericapsular nerve group block

Saline placebo group

PLACEBO COMPARATOR
Procedure: pericapsular nerve group block

Interventions

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.

Pericapsular nerve group blockSaline placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for hip arthroplasty

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, 510180, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 21, 2020

Study Start

September 10, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

September 14, 2020

Record last verified: 2020-09

Locations