NCT05091398

Brief Summary

The optimal analgesia method in video-assisted thoracoscopic surgery (VATS) remains controversial. 105 patients scheduled to undergo video-assisted thoracic surgery under general anesthesia will be included. Patients will be randomly allocated to receive ultrasound-guided ESP blocks on T4 and T6 levels (Group ESPB, n = 35),PVB (Group PVB, n = 35) after the anesthesia induction and turning the patient in the lateral position or (Group ICNB, n=35) with 30 mL 0.5% bupivacaine +50 µ adrenaline will be injected by the surgeon through the thoracoscope .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

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

October 1, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

November 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

January 12, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

October 1, 2021

Last Update Submit

January 11, 2022

Conditions

Keywords

Erector spinae planeparavertebralintercostal nerve blockVATS

Outcome Measures

Primary Outcomes (1)

  • end tidal sevoflurane

    intraoperative end tidal sevoflurane

    150 minutes

Secondary Outcomes (1)

  • Blood pressure

    150 minutes

Study Arms (3)

Group I

ACTIVE COMPARATOR

ultrasound-guided erector spinae block on T4 and T6 levels after the anesthesia induction and turning the patient in the lateral position

Other: Regional analgesia of thoracic surgical patients

Group II

ACTIVE COMPARATOR

ultrasound-guided paravertebral block on T4 and T6 levels after the anesthesia induction and turning the patient in the lateral position

Other: Regional analgesia of thoracic surgical patients

Group III

ACTIVE COMPARATOR

ultrasound-guided intercostal nerve block on T4 and T6 levels after the anesthesia induction and turning the patient in the lateral position

Other: Regional analgesia of thoracic surgical patients

Interventions

ultrasound-guided erector spinae block on T4 and T6 levels ,paravertebral block or intercostal nerve block after the anesthesia induction and turning the patient in the lateral position with 30 mL 0.5% bupivacaine +50 µ adrenaline will be injected by the surgeon through the thoracoscope .

Group IGroup IIGroup III

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I and II patients
  • Thoracic surgery

You may not qualify if:

  • Coagulation defect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mona Mohamed Mogahed

Tanta, Elgharbia, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 1, 2021

First Posted

October 25, 2021

Study Start

November 5, 2021

Primary Completion

January 10, 2022

Study Completion

January 10, 2022

Last Updated

January 12, 2022

Record last verified: 2022-01

Locations