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

Breast Cancer Patients Clinical Trial

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: Recruiting

Administrative data

• NCT number: NCT03046238
• Other study ID #: 222
• Status: Recruiting
• Phase: Phase 3
• First received: February 2, 2017
• Last updated: February 23, 2017
• Start date: February 2, 2017
• Est. completion date: April 2, 2017

Study information

• Verified date: February 2017
• Source: South Egypt Cancer Institute
• Contact: mohamad F mohamad, MD
• Phone: +201093942354
• Email: mfaroukma[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2, 2017
• Est. primary completion date: April 2, 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)

Exclusion Criteria:

• a history of bleeding diathesis,

• relevant drug allergy

• opioid dependence,

• sepsis,

• those with psychiatric illnesses

Related Conditions & MeSH terms

• Breast Cancer Patients
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute, Assiut University, Assiut, Egypt.	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
Primary	morphine consumption mg/day	by Patient-controlled analgesia (PCA) device	48 HOURS
Primary	Visual Analog Scale (VAS), scored from 0-10	pain measurement	48 hours
Secondary	first request of analgesia	time of the first request of analgesia postoperative if the VAS = 3	48 hours
Secondary	level of stress hormones	cortisol level	48 hours
Secondary	Adverse Events	Nausea Vomiting Bradycardia Hypotension Arrhythmia Pneumothorax Vascular injury Nausea Vomiting Bradycardia Hypotension Arrhythmia Pneumothorax Vascular injury Nausea,Vomiting,Arrhythmia.Hypotension,Pneumothorax,Vascular injury andItching	48 hours