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

South Egypt Cancer Institute

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer Patients

Treatments: Drug: Dexmedetomidine; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03046238

222

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

dexmetedomedine

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

control

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo