| 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 |
|
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Details of Secondary Sponsor
|
|
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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
|
|
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., |
|
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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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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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. |
|
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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 |
|
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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. |