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

S

South Egypt Cancer Institute

Status and phase

Unknown
Phase 3

Conditions

Breast Cancer Female

Treatments

Drug: Dexmedetomidine Injection [Precedex]
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

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

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]

Trial contacts and locations

1

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Central trial contact

mohammed f abd elhamed, ass.lecturer; mohammad f mohammad, lecturer

Data sourced from clinicaltrials.gov

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