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

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Patients
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assuit, Egypt, 171516
    • Recruiting
    • South Egypt Cancer Institute, Assiut University, Assiut, Egypt.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dexmetedomedine; preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)	Drug: Dexmedetomidine; preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)
Placebo Comparator: control; preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine	Drug: placebo; preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine; Other Names: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphine consumption mg/day	by Patient-controlled analgesia (PCA) device	48 HOURS
Visual Analog Scale (VAS), scored from 0-10	pain measurement	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first request of analgesia	time of the first request of analgesia postoperative if the VAS ≥ 3	48 hours
level of stress hormones	cortisol level	48 hours
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

Collaborators and Investigators

• Sponsor: South Egypt Cancer Institute
• Investigators: Principal Investigator: mohamad F mohamad, MD, Assiut University; Study Director: Saher mohamad, MD, Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Anticipated): April 2, 2017
• Study Completion (Anticipated): April 2, 2017

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 4, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes