search
Back to results

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

Primary Purpose

Breast Cancer Patients

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
placebo
Sponsored by
South Egypt Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer Patients

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

dexmetedomedine

control

Arm Description

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

preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine

Outcomes

Primary Outcome Measures

morphine consumption mg/day
by Patient-controlled analgesia (PCA) device
Visual Analog Scale (VAS), scored from 0-10
pain measurement

Secondary Outcome Measures

first request of analgesia
time of the first request of analgesia postoperative if the VAS ≥ 3
level of stress hormones
cortisol level
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

Full Information

First Posted
February 2, 2017
Last Updated
February 23, 2017
Sponsor
South Egypt Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03046238
Brief Title
Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Breast Cancer Patients
Official Title
Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Patient Undergoing Breast Cancer Surgery :A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
April 2, 2017 (Anticipated)
Study Completion Date
April 2, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Patients

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dexmetedomedine
Arm Type
Active Comparator
Arm Description
preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
control
Intervention Description
preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine
Primary Outcome Measure Information:
Title
morphine consumption mg/day
Description
by Patient-controlled analgesia (PCA) device
Time Frame
48 HOURS
Title
Visual Analog Scale (VAS), scored from 0-10
Description
pain measurement
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
first request of analgesia
Description
time of the first request of analgesia postoperative if the VAS ≥ 3
Time Frame
48 hours
Title
level of stress hormones
Description
cortisol level
Time Frame
48 hours
Title
Adverse Events
Description
Nausea Vomiting Bradycardia Hypotension Arrhythmia Pneumothorax Vascular injury Nausea Vomiting Bradycardia Hypotension Arrhythmia Pneumothorax Vascular injury Nausea,Vomiting,Arrhythmia.Hypotension,Pneumothorax,Vascular injury andItching
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamad F mohamad, MD
Phone
+201093942354
Email
mfaroukma@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamad F mohamad, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saher mohamad, MD
Organizational Affiliation
Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.
Official's Role
Study Director
Facility Information:
Facility Name
South Egypt Cancer Institute, Assiut University, Assiut, Egypt.
City
Assuit
ZIP/Postal Code
171516
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs