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Serratus Anterior Plane Block Versus Erector Spinae Plane Block With Dexmedetomidine Added to Bupivacaine for Ultrasound-Guided Pain Management After Mastectomy

NCT ID: NCT06737458

Last Updated: 2024-12-17

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-07-01

Brief Summary

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This study aimed to compare the serratus plane block versus the erector spinae plane block with dexmedetomidine added to bupivacaine for acute pain management after breast surgeries.

Detailed Description

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Approximately 40-60% of breast surgery patients endure severe acute postoperative pain, with over 10% of patients experiencing severe pain for six to twelve months (post-mastectomy pain syndrome).

Dexmedetomidine has analgesic properties, which could be related to the stimulation of α2 adrenoceptors, inhibition of nerve conduction through C and Aδ fibers, and the local release of encephalin.

Serratus plane block (SPB) is an effective approach for breast surgery analgesia due to its simplicity of delivery, minimal risk of adverse effects, and ability to provide significant pain relief.

The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB can be given unilaterally during modified radical mastectomy.

Conditions

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Serratus Anterior Plane Block Erector Spinae Plane Block Dexmedetomidine Bupivacaine Ultrasound Pain Management Mastectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Serratus anterior plane block group

Patients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.

Group Type ACTIVE_COMPARATOR

Bupivacaine + Dexmedetomidine

Intervention Type DRUG

Patients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.

Erector spinae plane block group

Patients received erector spinae plane block at T5 on the operated side and will receive bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.

Group Type EXPERIMENTAL

Bupivacaine + Dexmedetomidine

Intervention Type DRUG

Patients received erector spinae plane block at T5 on the operated side and will receive bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.

Interventions

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Bupivacaine + Dexmedetomidine

Patients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.

Intervention Type DRUG

Bupivacaine + Dexmedetomidine

Patients received erector spinae plane block at T5 on the operated side and will receive bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.

Intervention Type DRUG

Other Intervention Names

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Serratus anterior plane block Erector spinae plane block

Eligibility Criteria

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Inclusion Criteria

* Women aged \>20 years.
* Patient's approval.
* American Society of Anesthesiologists (ASA) physical status I-II.
* Patients underwent breast surgeries.

Exclusion Criteria

* Known allergy to local anesthetics, opioids, or dexmedetomidine medications.
* Advanced heart block, ventricular dysfunction.
* Skin infection at the site of injection.
* Pre-existing chronic pain.
* Coagulopathies, significant liver or renal insufficiency.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Hend Saad Rizk Farhat

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelshiekh University, Kafrelshiekh, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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KFSIRB200-438

Identifier Type: -

Identifier Source: org_study_id