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Stellate Ganglionic Block Versus Stellate Ganglionic Block Plus Pecs II Block for Mastectomy Pain

Primary Purpose

Post Mastectomy Pain Syndrome, After Breast Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stellate ganglionic block
Pecs II block
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Mastectomy Pain Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists physical status III or IV.
  • Patients having irradiating pain of anterior chest wall and axilla after breast surgery.
  • Patients having irradiating pain of ipsilateral arm after breast surgery
  • Pain not responding to conservative treatment
  • Pain persisting for more than 3 month

Exclusion Criteria:

  • Local skin infection
  • Coagulation or blood disease
  • Pregnancy
  • Postpartum or lactating females
  • Allergy to the study medications.
  • Severely altered consciousness level.
  • Psychiatric disorder
  • Drug abuse
  • Spine or chest wall deformities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Stellate ganglionic block

    Pecs II block

    Arm Description

    Ultrasound guided stellate ganglionic block

    Ultrasound guided Pecs II block

    Outcomes

    Primary Outcome Measures

    Pain scores
    100 mm- visual analog pain scale

    Secondary Outcome Measures

    The range of motion of the glenohumeral joint
    Improvements in the range of motion of the glenohumeral joint, which included forward extension and external rotation will be recorded using scoring system score 0 to 9 for some movements range and 0 to 160 for others
    The quality of life score
    The quality of life will be assessed using the score QOLSF 36

    Full Information

    First Posted
    December 24, 2015
    Last Updated
    February 5, 2016
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02641951
    Brief Title
    Stellate Ganglionic Block Versus Stellate Ganglionic Block Plus Pecs II Block for Mastectomy Pain
    Official Title
    Stellate Ganglionic Block Versus Combined Stellate Ganglionic Block and Modified Pectoral Nerve Block in Treatment of Post Mastectomy Pain Syndrome.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    May 2016 (Anticipated)
    Study Completion Date
    July 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Post mastectomy pain syndrome result from surgical damage to the intercostobrachial nerve, the lateral cutaneous branch of the second intercostal nerve that is often resected at mastectomy. result from surgical damage to the intercostobrachial nerve, the lateral cutaneous branch of the second intercostal nerve that is often resected at mastectomy, A second version of the pectoral nerve block is described, called ''modified Pecs block'' or Pecs block type II. This novel approach aims to block at least the pectoral nerves, the intercostobrachial, intercostals III-IV-V-VI and the long thoracic nerve. These nerves need to be blocked to provide complete analgesia during breast surgery
    Detailed Description
    The aim of this study is to evaluate the efficacy of ultrasound guided stellate ganglionic block alone versus stellate ganglionic block plus pecs II block in management of chronic postmastectomy pain ,patient will be trained to use visaual analog scale to describe their pain range of movement will be assessed using manual geniometry at post procedure visits at one month ,3 months and 6 months procedures in each group will done using ultrasound guidance mixture will be used. All patients will be informed about the procedure and its possible consequences after detailed explanation of protocol of this study. Written informed consents will be obtained before the procedure. With each block, an intravenous cannula will be inserted and secured. All suitable resuscitation equipment and drugs will be available. Vital signs (heart rate, blood pressure, and oxygen saturation) will be monitored throughout the procedure and up to 1 hour after the block performance. Midazolam 0.02 ug/kg will be administered intravenously as premedication. Brief evaluation will be done for all patients with regard to their systemic diseases, general condition, and coagulation status. All patients will be familiar with the use of 10-cm visual analogue scale score (VAS) identifying 0 as no pain and 10 as worst imaginable pain.Basal assessment of range of movement for abduction ,external rotation ,and forward flextion using manual geniometry and patients will be asked to complete Quality of life questionnaire

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Mastectomy Pain Syndrome, After Breast Surgery

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stellate ganglionic block
    Arm Type
    Placebo Comparator
    Arm Description
    Ultrasound guided stellate ganglionic block
    Arm Title
    Pecs II block
    Arm Type
    Active Comparator
    Arm Description
    Ultrasound guided Pecs II block
    Intervention Type
    Other
    Intervention Name(s)
    Stellate ganglionic block
    Intervention Description
    Ultrasound guided stellate ganglionic block
    Intervention Type
    Other
    Intervention Name(s)
    Pecs II block
    Intervention Description
    Ultrasound guided Pecs II block
    Primary Outcome Measure Information:
    Title
    Pain scores
    Description
    100 mm- visual analog pain scale
    Time Frame
    for six months after the procedure
    Secondary Outcome Measure Information:
    Title
    The range of motion of the glenohumeral joint
    Description
    Improvements in the range of motion of the glenohumeral joint, which included forward extension and external rotation will be recorded using scoring system score 0 to 9 for some movements range and 0 to 160 for others
    Time Frame
    for six months after the procedure
    Title
    The quality of life score
    Description
    The quality of life will be assessed using the score QOLSF 36
    Time Frame
    for six months after the procedure

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists physical status III or IV. Patients having irradiating pain of anterior chest wall and axilla after breast surgery. Patients having irradiating pain of ipsilateral arm after breast surgery Pain not responding to conservative treatment Pain persisting for more than 3 month Exclusion Criteria: Local skin infection Coagulation or blood disease Pregnancy Postpartum or lactating females Allergy to the study medications. Severely altered consciousness level. Psychiatric disorder Drug abuse Spine or chest wall deformities
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zenat E Mohamed, MD
    Organizational Affiliation
    Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Reem A Sharkawy, MD
    Organizational Affiliation
    Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Stellate Ganglionic Block Versus Stellate Ganglionic Block Plus Pecs II Block for Mastectomy Pain

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