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

South Egypt Cancer Institute

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer Female

Treatments: Drug: Bupivacaine; Drug: Dexmedetomidine Injection [Precedex]

Study type: Interventional

Funder types: Other

Identifiers

NCT03063073

224

Details and patient eligibility

About

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).

Full 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.

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

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Group I (Bupivacaine group)

Placebo Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Dexmedetomidine Injection [Precedex]

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine

Drug: Dexmedetomidine Injection [Precedex]