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CTRI Number  CTRI/2018/02/011736 [Registered on: 06/02/2018] Trial Registered Prospectively
Last Modified On: 16/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of dexmedetomidine as an add on drug in serratus anterior muscle block in breast surgery 
Scientific Title of Study   Role of dexmedetomidine as an adjuvant in serrates anterior muscle block - A randomised Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Siddarth Kalia 
Designation  Post Graduate Junior Resident 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Government medical college and hospital, sector 32-B, chandigarh, 160030

Chandigarh
CHANDIGARH
160030
India 
Phone  9915830265  
Fax    
Email  siddarth.kalia@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Satinder Gombar 
Designation  Professor  
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Government medical college and hospital, sector 32-B, chandigarh, 160030

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121520  
Fax    
Email  dr_sgombar@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Satinder Gombar 
Designation  Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Government medical college and hospital, sector 32-B, chandigarh, 160030

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121520  
Fax    
Email  dr_sgombar@rediffmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, Government medical college and hospital, sector 32-B, chandigarh, 160030. 
 
Primary Sponsor  
Name  Government Medical College and Hospital Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Government medical college and hospital, sector 32-B, chandigarh, 160030 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Siddarth Kalia  Government Medical College, Chandigarh  Operation Theatre Complex, Block - C, Government Medical College and Hospital, Chandigarh, 160030
Chandigarh
CHANDIGARH 
9915830265

siddarth.kalia@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, Patients suffering from carcinoma breast scheduled to undergo modified radical mastectomy (MRM), with ASA status 1-2.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Serratus Anterior Muscle block with the adjuvant (dexmedetomidine)  Interventional group to receive serrates anterior muscle block with local anaesthetic (0.25% ropicvacaine) 18 ml along with the adjuvant drug - dexmedetomidine (1mcg kg-1) to a total volume of 20 ml after induction of anaesthesia. 
Comparator Agent  Serratus Anterior Muscle block without the adjuvant  Control group to receive serrates anterior muscle block with local anaesthetic (0.25% ropivacaine) 18 ml with placebo (saline) adjuvant to a total volume of 20 ml after induction of anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Inclusion criteria:
1. Females diagnosed with carcinoma breast.
2. American Society of Anesthesiologists physical status I-II
3. Age 18-80 years.
 
 
ExclusionCriteria 
Details  Exclusion criteria:
1. History of relevant drug allergy.
2. History of psychiatric illness, substance abuse.
3. Severe cardiovascular, respiratory, liver diseases, metabolic or neurological disease.
4. Chronic treatment with analgesics.
• Pregnancy.
• Coagulopathy.
• Infection at planned injection site.
• Psychological inability of the patient to understand visual analogue scale.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To calculate and compare cumulative morphine consumption over 24 hours in patients receiving serratus anterior muscle block with and without dexmedetomidine.  Patient will be monitored for haemodynamic variables and these recordings will be assessed at 30mins, 1hr, 4hrs, 8hrs, 12hrs and 24hrs. Simultaneously, at these time intervals the pain will also be assessed using VAS score which will be evaluated both at rest and on movement.  
 
Secondary Outcome  
Outcome  TimePoints 
To monitor and compare reduction in pain intensity, to compare the dose of total anti emetics, to monitor haemodynamic variables and to note side effects of the procedure/drugs in use all for 24hrs.  Patient monitored for haemodynamic variables along with pain at rest and on movement, assessed at 30mins, 1hr, 4hr, 8hr, 12hr, 24hr 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/03/2018 
Date of Study Completion (India) 06/03/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 06/03/2019 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Breast cancer is the most common cancer in women worldwide as per data published by the World Health Organization. The treatment for breast cancer has evolved tremendously over the last decade with early surgical interventions being performed to increase the survival rates of those suffering from it. Modified radical mastectomy (MRM), is widely accepted and performed as a standard surgical procedure for breast carcinoma extensively across the world. Pain after MRM can be moderate to severe in nature and the method of pain alleviation after the procedure is still debatable and not yet clinically defined. Failure to provide adequate post operative analgesia may lead to impaired pulmonary and immune functions with increased risk of ileus, thromboembolism and myocardial infarction. In addition to undesirable effects like post operative nausea and vomiting (PONV), these patients are also at risk of developing chronic pain syndromes like post mastectomy pain syndrome (PMPS). Therefore adequate postoperative analgesia is mandatory after the surgery which not only hastens the recovery but also reduces the risk of development of PMPS as well.

 Multimodal analgesia forms the mainstay in provision of adequate postoperative pain relief after MRM, which can be achieved by either regional anesthetic techniques or administering intravenous analgesics or combination of both. Intravenous patient controlled analgesia with opioids provides the benefit of pain relief at the patient’s behest. However, use of opioids is associated with host of deleterious effects like sedation, constipation along with significant PONV. Herein lies the inherent advantage of the regional anesthetic techniques, which reduce the cumulative post operative opioid consumption as well as their side effects. Regional blocks like thoracic epidural, paravertebral, and cervical epidural blocks with local anesthetic agents have been used with varying degrees of success for post operative pain relief. All these blocks may be associated with potentially serious complications when performed using anatomical landmark techniques. With increase in the application of ultrasonography for performance of blocks, interfascial plane blocks have gained popularity due to precise visualization of the anatomy of area concerned and are being extensively employed for providing adequate postoperative analgesia in various surgical procedures.

Serratus anterior muscle block (SAM) has been described recently in MRM and the efficacy of this block is above par due to ultrasound guidance. Described by Blanco, SAM block is an interfascial plane block where the local anesthetic is administered between latissimus dorsi muscle (LDM) and serratus anterior muscle (SAM) using ultrasound. It provides analgesia by virtue of blocking lateral cutaneous branches of the thoracic intercostal nerves (T2-T12). The added advantages associated are decreased vascular injury/hematoma formation, improved sensory blockade, reduced local anesthetic toxicity and decreased opioid consumption. The role of addition of adjuvants to local anesthetics (LA) to prolong the duration of postoperative analgesia is well known in a variety of blocks. Various opioid and non opioid adjuvants like fentanyl, dexamethasone, tramadol, clonidine, dexmedetomidine, epinephrine, adenosine, midazolam, magnesium etc. have all been used in peripheral as well as neuraxial blocks. Search of available literature did not reveal any study evaluating the role of adjuvants with local anaesthetics in SAM block. Based on the hypothesis that addition of an adjuvant would increase the duration of analgesia in the post operative period the present study is being undertaken to compare the efficacy of SAM block with or without the addition of dexmedetomidine as an adjuvant to the local anaesthetic in patients scheduled to undergo elective MRM. 


 
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