Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Breast Cancer Patients

NCT ID: NCT03046238

Last Updated: 2017-02-27

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

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-02

Study Completion Date

2017-04-02

Brief Summary

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To Evaluate the effect of addition of Dexmedetomedine to ultrasound guided modified Pecs block on post operative analgesia \& stress response in patient undergoing modified radical mastectomy.

Detailed Description

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60 patients (age ≥29 years) who scheduled for modified radical mastectomy surgery under general anesthesia. Group I (Bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfasial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.Group II (Bupivacaine + Dexmedetomidine group) : preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfasial plane , and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.

Conditions

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Breast Cancer Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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dexmetedomedine

preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)

control

preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine

Interventions

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Dexmedetomidine

preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)

Intervention Type DRUG

placebo

preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine

Intervention Type DRUG

Other Intervention Names

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control

Eligibility Criteria

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Inclusion Criteria

* ASA I - II patients
* weight 50- 100 kg)

Exclusion Criteria

* a history of bleeding diathesis,
* relevant drug allergy
* opioid dependence,
* sepsis,
* those with psychiatric illnesses
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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South Egypt Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr.mohamad farouk mohamad

lecturer of anesthesia,ICU and pain relief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mohamad F mohamad, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Saher mohamad, MD

Role: STUDY_DIRECTOR

Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.

Locations

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South Egypt Cancer Institute, Assiut University, Assiut, Egypt.

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mohamad F mohamad, MD

Role: CONTACT

+201093942354

Other Identifiers

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222

Identifier Type: -

Identifier Source: org_study_id

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