NCT04738500

Brief Summary

Pericapsular nerve group block (PENG) has been deemed as a safe and effective regional technique for postoperative pain after knee arthroscopy.

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 Apr 2021

Shorter than P25 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

February 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

February 1, 2021

Last Update Submit

April 13, 2021

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • First analgesic demand

    The time interval from PENG blocks to the first analgesic demand.

    24 Hours

Secondary Outcomes (2)

  • Opioid consumption

    24 Hours

  • Numeric Rating Scale

    24 Hours

Study Arms (2)

PENG Block

ACTIVE COMPARATOR

PENG Block combinate with PCA

Procedure: PENG Block combinated with PCA

CONTROL

SHAM COMPARATOR

PCA

Procedure: PCA

Interventions

PENG Block combinated with PCAPROCEDURE

After spinal anesthesia PENG block will be performed

Also known as: PCA
PENG Block
PCAPROCEDURE

PCA will be applied after surgery

CONTROL

Eligibility Criteria

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

You may qualify if:

  • Patients agreed to receive PENG block
  • Knee arthroscopy

You may not qualify if:

  • Other kinds of knee surgery
  • Patients refuse to receive PENG block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KSU Faculty of Medicine Research Hospital

Kahramanmaraş, 46200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Passive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesAntigen-Antibody ReactionsImmune System Phenomena

Central Study Contacts

Bora Bilal, Assos. Prof.

CONTACT

05052354430bilalbora@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 4, 2021

Study Start

April 15, 2021

Primary Completion

May 30, 2021

Study Completion

June 15, 2021

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)