NCT04996290

Brief Summary

A clinical trial investigating the effect of a combined locoregional anesthesia technique on the postoperative analgesia outcomes after a total hip arthroplasty. A PENG block will be used in combination with a LFCN block. The results will be compared to a control group that is solely treated with intravenous analgesia. This technique aims to provide improved pain scores after surgery without interference of revalidation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

July 19, 2021

Last Update Submit

August 6, 2021

Conditions

Keywords

regional anesthesiapostoperative paintotal hip arthroplastypericapsular nerve group block

Outcome Measures

Primary Outcomes (3)

  • Initial pain score

    numeric rating score (NRS) of 0 to 10

    0 hours postoperative

  • Pain score after 2h

    numeric rating score (NRS) of 0 to 10

    2 hours postoperative

  • Pain score after 24h

    numeric rating score (NRS) of 0 to 10

    24 hours postoperative

Secondary Outcomes (5)

  • Initial motor function

    0 hours postoperative

  • Motor function after 2h

    2 hours postoperative

  • Motor function after 24h

    24 hours postoperative

  • Intraoperative opioids

    intraoperative

  • Postoperative opioids

    24 hours postoperative

Study Arms (2)

PENG + LFCN block

ACTIVE COMPARATOR

The participants in this group received a combined regional technique just before surgery: * Pericapsular nerve group (PENG) block * Lateral femoral cutaneus nerve (LFCN) block

Procedure: PENG + LFCN blockDrug: Ropivacaine injection

No regional anesthesia

NO INTERVENTION

Control group

Interventions

Regional anesthesia technique

Also known as: pericapsular nerve group block, lateral femoral cutaneous nerve block
PENG + LFCN block

Local anesthetic used for peripheral nerve block.

Also known as: ropivacaine 0.375%
PENG + LFCN block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients who underwent a primary total hip replacement under general anesthesia

You may not qualify if:

  • insulin dependent diabetes mellitus
  • chronic pain
  • severe dementia or mental retardation
  • allergy to local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Monica

Deurne, Belgium

Location

Related Publications (5)

  • Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

    PMID: 30063657BACKGROUND
  • Morrison C, Brown B, Lin DY, Jaarsma R, Kroon H. Analgesia and anesthesia using the pericapsular nerve group block in hip surgery and hip fracture: a scoping review. Reg Anesth Pain Med. 2021 Feb;46(2):169-175. doi: 10.1136/rapm-2020-101826. Epub 2020 Oct 27.

    PMID: 33109730BACKGROUND
  • Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.

    PMID: 31663402BACKGROUND
  • Roy R, Agarwal G, Pradhan C, Kuanar D. Total postoperative analgesia for hip surgeries, PENG block with LFCN block. Reg Anesth Pain Med. 2019 Mar 28:rapm-2019-100454. doi: 10.1136/rapm-2019-100454. Online ahead of print. No abstract available.

    PMID: 30923252BACKGROUND
  • Hojer Karlsen AP, Geisler A, Petersen PL, Mathiesen O, Dahl JB. Postoperative pain treatment after total hip arthroplasty: a systematic review. Pain. 2015 Jan;156(1):8-30. doi: 10.1016/j.pain.0000000000000003.

    PMID: 25599296BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Yzabel Vandevivere, MD

    AZ Monica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2021

First Posted

August 9, 2021

Study Start

June 1, 2020

Primary Completion

September 30, 2020

Study Completion

October 1, 2020

Last Updated

August 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations