NCT04498234

Brief Summary

compare between ultrasound guided erector spinae plane block and ultrasound guided paravertebral block on acute and chronic post mastectomy pain

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
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

May 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

3.6 years

First QC Date

July 19, 2020

Last Update Submit

October 29, 2023

Conditions

Comparison Between Ultrasound Guided Erector Spinae Plane Block and Para-vertebral Block on Acute and Chronic Post Mastectomy Pain

Outcome Measures

Primary Outcomes (1)

  • analgesic requirement

    Total morphine consumption during first 24 hours post operatively.

    24 hours

Secondary Outcomes (2)

  • stress response

    24 hours

  • Chronic post mastectomy pain

    6 month

Study Arms (3)

GROUP(A) (CONTROL GROUP)

EXPERIMENTAL

Patients will receive standard regimen of anesthesia .

Procedure: ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %

Group B

EXPERIMENTAL

Patients will receive 0.25% bupivacaine (20 ml ) into interfascial plane below erector spinae muscle at level of T4.

Procedure: ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %

Group C

EXPERIMENTAL

Patients will receive (0.3 ml /kg ) 0.25% bubivicaine divided equially at each level of T2 , T4 and T6 at thoracic paravertebral space .

Procedure: ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %

Interventions

ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %PROCEDURE

One groupvwill receive 0.25% bupivacaine (20 ml ) into interfascial plane below erector spinae muscle at level of T4 and the other group willreceive (0.3 ml /kg ) 0.25% bubivicaine divided equially at each level of T2 , T4 and T6 at thoracic paravertebral space .

GROUP(A) (CONTROL GROUP)Group BGroup C

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gender : female .
  • Age : 20 to 70 years old .
  • Scheduled for : either left or right modified radical mastectomy (MRM)
  • Physical status : American society of anesthesiologists (ASA) physical status I and II.

You may not qualify if:

  • ASA \> III 2 -age\> 70 years old. 3-patients refusal to the procedure. 4-Infection of the skin at or near site of needle puncture. 5- Coagulopathy . 6- Drug hypersensitivity or allergy to the studied drugs. 7- Central or peripheral neuropthy . 8-Pre-operative opoid consumption ( within 24 hours preoperative ) 9- Anomalies of the vertebral column .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer Institute

Asyut, 171516, Egypt

RECRUITING

Related Publications (1)

  • Amr SA, Othman AH, Ahmed EH, Naeem RG, Kamal SM. Comparison between ultrasound guided erector spinae plane block and paravertebral block on acute and chronic post mastectomy pain after modified radical mastectomy: randomized controlled trial. BMC Anesthesiol. 2024 Nov 21;24(1):420. doi: 10.1186/s12871-024-02810-4.

    PMID: 39574036DERIVED

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Romany G. Naeem, MSc

    assistant lecturer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Romany G. Naeem, MSc

CONTACT

1006231332Romanytreka22@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

July 19, 2020

First Posted

August 4, 2020

Study Start

May 1, 2020

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations

EG(1)