Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block

Phase 3

• Conditions: Breast Cancer Female
• Interventions: Drug: Dexmedetomidine Injection [Precedex]; Drug: Bupivacaine

• Registration Number: NCT03063073
• Lead Sponsor: South Egypt Cancer Institute

Brief Summary

The Pecs block (pectoral nerves block) is an easy and reliable superficial block inspired by the infraclavicular block approach and the intercostal abdominis plane blocks . Many additives were used in combination with local anesthetics in Pecs block to prolong the postoperative analgesia (fentanyl, dexmedetomidine).

Detailed Description

60 patients 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 interfascial 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 interfascial plane , and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-23
• Last Update Submitted: 2017-02-23
• Study First Posted: 2017-02-24
• Last Update Posted: 2017-02-24
• Study Start: 2017-02-25
• Primary Completion: 2017-05-30
• Study Completion: 2017-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• ASA I - II patients

  • weight 50- 100 kg

• age 18-60 years

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Exclusion Criteria

• History of bleeding diathesis
• Relevant drug allergy
• Opioid dependence
• Sepsis
• Those with psychiatric illnesses that would interfere with perception and assessment of pain will be excluded from the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine Injection [Precedex]	Dexmedetomidine Injection [Precedex]	ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine Injection \[Precedex\] (1 µg/kg) divided into 20 ml injected between the pectoralis muscles and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.
Group I (Bupivacaine group)	Bupivacaine	ultrasound guided modified Pec's block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles and 20 ml between the Pectoralis minor muscle and the serratus muscle
Dexmedetomidine Injection [Precedex]	Bupivacaine	ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine Injection \[Precedex\] (1 µg/kg) divided into 20 ml injected between the pectoralis muscles and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.

Primary Outcome Measures

Name	Time	Method
I.V patient controlled analgesia (PCA) morphine consumption	48 hours postoperative	the total dose of I.V patient controlled analgesia (PCA) morphine consumption in the first 48 hours postoperative

Secondary Outcome Measures

Name	Time	Method
pain relief	48 hour	by visual analogue scale measurement

Trial Locations

Locations (1)

South EGYPT cancer institute; 🇪🇬 Assuit, Egypt