Dexmedetomidine vs Dexamethasone as Adjuvant to Bupivacaine in Bilevel Erector Spinae Plane Block in Breast Surgeries

NCT ID: NCT05591417

Last Updated: 2024-10-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-27

Study Completion Date

2024-09-30

Brief Summary

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High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries.

Detailed Description

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High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries. Adding adjuvant drugs as dexmedetomidine or dexamethasone can augment the local anesthetic effect for the regional block used.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intravenous morphine

Patients will receive intravenous morphine 0.1 mg/kg

Group Type ACTIVE_COMPARATOR

Intravenous morphine

Intervention Type DRUG

Intravenous morphine 0.1 mg/kg

Bilevel erector spinae plane block

Patients will receive erector spinae plane block at 2 levels

Group Type EXPERIMENTAL

Bilevel Erector spinae plane block

Intervention Type PROCEDURE

Patients will receive bilevel erector spinae plane block with bupivacaine

Bilevel erector spinae plane block with dexamethasone

Patients will receive erector spinae plane block at 2 levels with dexamethasone

Group Type EXPERIMENTAL

Bilateral Erector spinae plane block with dexamethasone

Intervention Type PROCEDURE

Patients will receive bilevel erector spinae plane block with bupivacaine and dexamethasone

Bilevel erector spinae plane block with dexmedetomidine

Patients will receive erector spinae plane block at 2 levels with dexmedetomidine

Group Type EXPERIMENTAL

Bilateral Erector spinae plane block with dexmedetomidine

Intervention Type PROCEDURE

Patients will receive bilevel erector spinae plane block with bupivacaine and dexmedetomidine

Interventions

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Bilevel Erector spinae plane block

Patients will receive bilevel erector spinae plane block with bupivacaine

Intervention Type PROCEDURE

Bilateral Erector spinae plane block with dexamethasone

Patients will receive bilevel erector spinae plane block with bupivacaine and dexamethasone

Intervention Type PROCEDURE

Bilateral Erector spinae plane block with dexmedetomidine

Patients will receive bilevel erector spinae plane block with bupivacaine and dexmedetomidine

Intervention Type PROCEDURE

Intravenous morphine

Intravenous morphine 0.1 mg/kg

Intervention Type DRUG

Other Intervention Names

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BileveL ESPB Bilevel ESPB with dexamethasone Bilevel ESPB with dexmedetomidine Morphine

Eligibility Criteria

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Inclusion Criteria

* Female patients scheduled for Modified Radical Mastectomy MRM
* Physical status ASA II, III.
* Age (18-65) years
* Body mass index (BMI): (20-35) kg/m2.

Exclusion Criteria

* Patient refusal.
* Age \<18 years or \>65 years.
* BMI \<20 kg/m2 and \>35 kg/m2.
* Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids, dexamethasone, dexmedetomedine).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Walaa Youssef Elsabeeny

Assistant professor of Anesthesia and Pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walaa Y Elsabeeny, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University

Locations

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Walaa Y Elsabeeny

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AP2207-30110

Identifier Type: -

Identifier Source: org_study_id

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