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
About this trial
This is an interventional supportive care trial for Post Mastectomy Pain Syndrome
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
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
NCT ID
NCT02641951
First Posted
December 24, 2015
Last Updated
February 5, 2016
Sponsor
Mansoura University
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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