Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block

NCT ID: NCT05717114

Last Updated: 2024-01-31

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

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-05

Study Completion Date

2024-01-01

Brief Summary

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Regional anesthesia is an essential component of anesthesia and analgesia. It has many advantages, it decreases pain post operatively, improves patient outcome and allow early recovery and ambulation Post-operative pain following breast surgery results from injured muscles and nerves, management of acute post operative pain is a consistent factor for better outcome and patient satisfaction

Detailed Description

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All patients will be monitored by standard intraoperative monitoring that includes continuous electrocardiography (ECG), capnography, pulse oximetry, and non invasive blood pressure.

Induction of general anesthesia will be done by propofol 1.5-2 mg/kg and fentanyl 3µg/kg.

Tracheal intubation will be facilitated by administration of rocuronium 0.8 mg/kg. Anesthesia will be maintained with isoflurane 1MAC (Pecs block):the block will be performed with the patients in the supine position.The infraclavicular and axillary regions will be cleaned with antiseptic solution. the in plane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2 and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with Ultrasound

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized study
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group I

received plan bupivacaine1ml/Kg

Group Type PLACEBO_COMPARATOR

Pecs block

Intervention Type PROCEDURE

(Pecs block):the block will be performed with the patients in the supine position.The infraclavicular and axillary regions will be cleaned with antiseptic solution. the inplane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with ultrasound.

Group II

received plain bupivacaine 1ml/Kg plus dexmetomedine0.5 µg/Kg

Group Type ACTIVE_COMPARATOR

Pecs block

Intervention Type PROCEDURE

(Pecs block):the block will be performed with the patients in the supine position.The infraclavicular and axillary regions will be cleaned with antiseptic solution. the inplane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with ultrasound.

GroupIII

received plain bupivacaine 1ml/Kg plus dexmetomedine1µg/Kg

Group Type ACTIVE_COMPARATOR

Pecs block

Intervention Type PROCEDURE

(Pecs block):the block will be performed with the patients in the supine position.The infraclavicular and axillary regions will be cleaned with antiseptic solution. the inplane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with ultrasound.

Interventions

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Pecs block

(Pecs block):the block will be performed with the patients in the supine position.The infraclavicular and axillary regions will be cleaned with antiseptic solution. the inplane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with ultrasound.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adult patients
* aged 18-60years old
* ASA class 1 to 3
* scheduled for elective modified radical mastectomy

Exclusion Criteria

* patients refusal,
* coagulopathies
* concurrent anticoagulant therapy
* allergy to local anaesthetics
* infection at puncture site
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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rabab Mohammad habeeb

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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rabab M habeeb

Role: PRINCIPAL_INVESTIGATOR

Menoufia University

Locations

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Menoufia

Menoufia, Monufia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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1/2023,ANET2-1

Identifier Type: -

Identifier Source: org_study_id

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