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

Sponsor
South Egypt Cancer Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT03046238
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
1.9
Anticipated Duration (Months)
31
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Patient Undergoing Breast Cancer Surgery :A Comparative Study
Actual Study Start Date :
Feb 2, 2017
Anticipated Primary Completion Date :
Apr 2, 2017
Anticipated Study Completion Date :
Apr 2, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. morphine consumption mg/day [48 HOURS]

      by Patient-controlled analgesia (PCA) device

    2. Visual Analog Scale (VAS), scored from 0-10 [48 hours]

      pain measurement

    Secondary Outcome Measures

    1. first request of analgesia [48 hours]

      time of the first request of analgesia postoperative if the VAS ≥ 3

    2. level of stress hormones [48 hours]

      cortisol level

    3. Adverse Events [48 hours]

      Nausea Vomiting Bradycardia Hypotension Arrhythmia Pneumothorax Vascular injury Nausea Vomiting Bradycardia Hypotension Arrhythmia Pneumothorax Vascular injury Nausea,Vomiting,Arrhythmia.Hypotension,Pneumothorax,Vascular injury andItching

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 South Egypt Cancer Institute, Assiut University, Assiut, Egypt. Assuit Egypt 171516

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr.mohamad farouk mohamad, lecturer of anesthesia,ICU and pain relief, South Egypt Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT03046238
    Other Study ID Numbers:
    • 222
    First Posted:
    Feb 8, 2017
    Last Update Posted:
    Feb 27, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Breast Neoplasms
    Dexmedetomidine

    Study Results

    No Results Posted as of Feb 27, 2017