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

NCT ID: NCT03063073

Last Updated: 2026-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-25
• Study Completion Date: 2017-06-15

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.

Conditions

Breast Cancer Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group I (Bupivacaine group)

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

Group Type: PLACEBO_COMPARATOR

Bupivacaine Injection [Marcaine]

Intervention Type: DRUG

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 muscl

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 Type: ACTIVE_COMPARATOR

Dexmedetomidine Injection [Precedex]

Intervention Type: DRUG

ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine (markyrene R sigma -Tec, Egypt) plus (1 µg/kg) Dexmedetomidine Injection \[Precedex\]

Bupivacaine Injection [Marcaine]

Intervention Type: DRUG

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 muscl

Interventions

Dexmedetomidine Injection [Precedex]

ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine (markyrene R sigma -Tec, Egypt) plus (1 µg/kg) Dexmedetomidine Injection \[Precedex\]

Intervention Type: DRUG

Bupivacaine Injection [Marcaine]

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 muscl

Intervention Type: DRUG

Other Intervention Names

[Precedex]

Eligibility Criteria

Inclusion Criteria

• ASA I - II patients

• weight 50- 100 kg
• age 18-60 years

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

South Egypt Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Farghaly Abd El hamid Ahmed

assisstant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sahar m abd elbaqy, professor

Role: STUDY_DIRECTOR

manager

Locations

South EGYPT cancer institute

Asyut, , Egypt

Countries

Egypt

Other Identifiers

224

Identifier Type: -

Identifier Source: org_study_id