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

Breast Cancer Female Clinical Trial

— pec`s  

Official title:

Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Patient Undergoing Breast Cancer Surgery :A Comparative Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03063073
• Other study ID #: 224
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 8, 2017
• Last updated: February 23, 2017
• Start date: February 25, 2017
• Est. completion date: June 15, 2017

Study information

• Verified date: February 2017
• Source: South Egypt Cancer Institute
• Contact: mohammed f abd elhamed, ass.lecturer
• Phone: 01015249890
• Email: m.farghaly.na[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 15, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Drug:
• 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]
• Bupivacaine

Locations

Country	Name	City	State
Egypt	South EGYPT cancer institute	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
South Egypt Cancer Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	stress response	Three Blood samples were collected from each patient for detection of cortisol & prolactin levels, the first was preoperative, the second and the third were 1h and 24 h postoperatively	24 hour
Primary	I.V patient controlled analgesia (PCA) morphine consumption	the total dose of I.V patient controlled analgesia (PCA) morphine consumption in the first 48 hours postoperative	48 hours postoperative
Secondary	pain relief	by visual analogue scale measurement	48 hour