NCT04231123

Brief Summary

This study examine the effect of Pericapsular Nerve Group (PENG) Block on analgesia after elective hip arthroplasty. Half of participants will receive a PENG Block with local anesthetic, while the other half will receive a PENG Block with a placebo.

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
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable postoperative-pain

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

January 8, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

January 8, 2020

Last Update Submit

January 26, 2021

Conditions

Postoperative Pain

Keywords

Elective Hip SurgeryPENG Block

Outcome Measures

Primary Outcomes (1)

  • Pain Score on first Mobilization

    A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]) will be used to evaluate pain on first mobilization at day 0 after surgery

    Postoperative time until midnight day 0

Secondary Outcomes (22)

  • Maximum Pain Score in Post-Anaesthesia Care Unit

    Through postoperative time during Post Anesthesia Care Unit stay at day 0

  • Morphine Consumption at Day 0

    Postoperative time until midnight day 0

  • Piritramid Consumption

    Through the end of surgery until Post Anesthesia Care Unit discharge to the ward at day 0

  • Morphine Consumption at Day 1

    Postoperative time during Post Anesthesia Care Unit stay at day 0

  • Morphine Consumption at Day 2

    Postoperative time until midnight day 2

  • +17 more secondary outcomes

Other Outcomes (4)

  • Patient satisfaction after 24h

    24 hours after surgery

  • Length of hospital stay

    During hospital stay, up to 1 week

  • PACU stay

    Postoperative time during Post Anesthesia Care Unit stay at day 0

  • +1 more other outcomes

Study Arms (2)

PENG group

EXPERIMENTAL

PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine

Procedure: PENG Block with local anesthetic

Placebo group

PLACEBO COMPARATOR

PENG block with 20 ml of 0,9% saline

Procedure: PENG Block with 0,9% saline

Interventions

PENG Block with local anestheticPROCEDURE

After induction of general anesthesia, PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.

PENG group
PENG Block with 0,9% salinePROCEDURE

After induction of general anesthesia, PENG block with 20 ml of 0,9% saline will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.

Placebo group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective total hip arthroplasty
  • General anesthesia
  • Enhanced Recovery Program

You may not qualify if:

  • American Society of Anesthesiologists (ASA) Score \> 2
  • Drug allergy
  • Significant psychiatric disturbances
  • Preoperative opioid use
  • Contraindication to acetaminophen, celecoxib, methylprednisolone or tranexamic acid
  • Body Mass Index \> 40 kg/m²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Tivoli

La Louvière, 7100, Belgium

RECRUITING

Related Publications (1)

  • 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

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Nicolas Van Rompaey, MD

    Centre Hospitalier Universitaire de Tivoli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Van Rompaey, MD

CONTACT

+3264276111nvrompae@chu-tivoli.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Injected solutions will be prepared by an anesthetist not involved in the study protocol.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 18, 2020

Study Start

January 20, 2020

Primary Completion

December 31, 2021

Study Completion

March 15, 2022

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

BE(1)