NCT04264689

Brief Summary

the study aim is to compare the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 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

First Submitted

Initial submission to the registry

February 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2020

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

8 months

First QC Date

February 9, 2020

Last Update Submit

December 3, 2020

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • visual analogue score

    minimum value 0 and maximum value 10

    24 hours

Secondary Outcomes (1)

  • mean arterial blood pressure

    24 hours

Study Arms (3)

thoracic epidural

ACTIVE COMPARATOR

thoracic epidural will be done before induction of general anesthesia

Procedure: thoracic epidural

serratus anterior block

EXPERIMENTAL

ultrasound guided serratus anterior block will be done after induction of general anesthesia

Procedure: serratus anterior block

erector spinae block

EXPERIMENTAL

ultrasound guided erector spinae block will be done after induction of general anesthesia

Procedure: erector spinae block

Interventions

serratus anterior blockPROCEDURE

ultrasound guided block

serratus anterior block
thoracic epiduralPROCEDURE

thoracic epidural

thoracic epidural
erector spinae blockPROCEDURE

ultrasound guided block

erector spinae block

Eligibility Criteria

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

You may qualify if:

  • patients scheduled for thoracotomy age 18-65

You may not qualify if:

  • patient refusal coagulation defects abnormal kidney or liver functions local infection at site of block bone metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of anesthesia and pain medicine. National Cancer Institute

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Tea

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • walaa Y elsabeeny, MD

    Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia and pain management

Study Record Dates

First Submitted

February 9, 2020

First Posted

February 11, 2020

Study Start

March 2, 2020

Primary Completion

October 28, 2020

Study Completion

November 3, 2020

Last Updated

December 7, 2020

Record last verified: 2020-12

Locations

EG(1)