Ultrasound Guided Thoracic ESPB for Post Mastectomy Pain Control, Comparing 2 Dosing Regimens of Lidocaine With Different Drug Volumes

NCT ID: NCT05514977

Last Updated: 2022-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2022-12-30

Brief Summary

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The investigators compare 2 different drug regimens using 2 different volumes of lidocaine with the same drug content (i.e. different concentrations) as regards efficacy of post operative analgesia following mastectomy surgery

Detailed Description

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Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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L group

Patients are given 20 ml of 2 % lidocaine for ESPB

Group Type ACTIVE_COMPARATOR

Erector spine plane block

Intervention Type PROCEDURE

Thoracic ESPB

H group

Patients are given 40 ml of 1 % lidocaine for ESPB

Group Type ACTIVE_COMPARATOR

Erector spine plane block

Intervention Type PROCEDURE

Thoracic ESPB

Interventions

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Erector spine plane block

Thoracic ESPB

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA 2 \& 3 for elective breast cancer surgery

Exclusion Criteria

* ASA \> 3
* BMI \> 35 kg/m2
* Contraindications to LA (coagulopathy and local infection)
* Allergy to the drug
* Cardiac, hepatic and renal patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Kareem

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Kareem

Role: STUDY_DIRECTOR

Kasr alainy hospital, Cairo University

Locations

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Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed Kareem

Role: CONTACT

202 - 01119966884

Other Identifiers

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LOW VS HIGH VOLUME LIDOCAINE

Identifier Type: -

Identifier Source: org_study_id

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