| CTRI Number |
CTRI/2019/03/018067 [Registered on: 13/03/2019] Trial Registered Prospectively |
| Last Modified On: |
07/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To observe and compare the effect of injection of a drug ( medicine) at two different sites in between muscles for pain relief in patients who undergo breast cancer surgery. |
|
Scientific Title of Study
|
Comparison of ultrasound-guided erector spinae plane block with serratus anterior muscle block in patients undergoing modified radical mastectomy- A randomized 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 |
Tenzin Nyima |
| Designation |
Postgraduate student |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care,Block D,Level 5, GMCH , sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8894940948 |
| Fax |
|
| Email |
drtenyima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Palta |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, GMCH, sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121523 |
| Fax |
|
| Email |
sanjeev_palta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Saroa |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, GMCH, sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
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Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care,GMCH, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive care |
| Address |
Block-D, Level 5,GMCH, sector 32, Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tenzin Nyima |
Government Medical College and Hospital, Chandigarh |
Department of Anaesthesia and Intensive care,Block-D,Level 5, GMCH, sector 32, Chandigarh
Chandigarh
CHANDIGARH |
8894940948
drtenyima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH, Chandigarh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group E- Erector spinae plane block.
|
Ipsilateral ultrasound guided Erector spinae plane block with 20 ml of 0.25% ropivacaine in patients undergoing modified radical mastectomy after induction of anaesthesia followed by intravenous patient controlled analgesia with morphine in the strength of 1mg/ml with lock out interval of five minutes and maximum dose of 0.2 mg/kg of morphine in 4 hours in the post-operative period for 24 hours.Rescue analgesia with 1 gm paracetamol if VAS score more than 40 even after maximum permissible dose of morphine over 4 hours. |
| Comparator Agent |
Group S-Serratus anterior muscle block. |
Ipsilateral ultrasound guided serratus anterior muscle block with 20 ml of 0.25% ropivacaine in patients undergoing modified radical mastectomy after induction of anaesthesia followed by intravenous patient controlled analgesia with morphine in the strength of 1mg/ml with lock out interval of five minutes and maximum dose of 0.2 mg/kg of morphine in 4 hours in the post-operative period for 24 hours.Rescue analgesia with 1 gm paracetamol if VAS score more than 40 even after maximum permissible dose of morphine over 4 hours. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1.Females suffering from carcinoma breast.
2.American Society of Anaesthesiologists status I-II
3.Age ranging from 18-80 years |
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.History of relevant drug allergy.
3.History of psychiatric illness and substance abuse.
4.Patient suffering from severe cardiovascular, respiratory,liver, metabolic or neurological disease.
5.Chronic treatment with analgesics.
6.Pregnant patient.
7.Coagulopathy.
8.Infection at planned injection site.
9.Psychological inability of the patient to understand and interpret visual analogue scale.
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the reduction in pain intensity in post-operative period by using linear visual analogue scale (VAS) score in patients receiving either ESP block or SAM block following MRM. |
Post-operative at 30 mins,1 hr,4 hrs,8 hrs,12 hrs and 24 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Morphine consumption over 24 hrs
2.Total dose of antiemetics over 24 hours.
3.Safety profile of both the blocks.
4.Changes in hemodynamic variables.
5.Side effects pertaining to the procedure or drugs. |
1.Post-operative at 30 mins,1 hr,4 hrs,8 hrs,12 hrs and 24 hrs.
2.Post-operative at 30 mins,1 hr,4 hrs,8 hrs,12 hrs and 24 hrs.
3.Post-operative at 30 mins,1 hr,4 hrs,8 hrs,12 hrs and 24 hrs.
4.Post-operative at 30 mins,1 hr,4 hrs,8 hrs,12 hrs and 24 hrs.
5.Post-operative at 30 mins,1 hr,4 hrs,8 hrs,12 hrs and 24 hrs. |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2019 |
| Date of Study Completion (India) |
10/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/08/2020 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None as 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 females and is the leading cause of cancer related deaths.The standard treatment options for early and localized breast cancer includes surgical modalities with modified radical mastectomy (MRM) being the most commonly employed surgical procedure undertaken for carcinoma breast. Pain following MRM is the major concern in the post-operative period as it can lead to poor surgical outcome and also has propensity to develop into chronic pain syndrome affecting 25-60% of the patients.Various modalities such as intravenous analgesics( opioids and non-opioids) and regional anaesthetic techniques such as thoracic epidurals,interscalene blocks,paravertebral blocks,cervical epidural blocks etc have been employed to control post-operative pain following MRM.Each modality has its pros and cons. Recently introduced ultrasound guided regional anaesthetic techniques have gained attention due to precise visualization of the anatomy of area concerned along with less complications.Erector spinae plane(ESP) block is the recently introduced block,first described by Forero for thoracic neuropathic pain.In ESP block, local anesthetic (LA) is injected deep to erector spinae muscle and superficial to transverse process ( usually at the level of T5) and provides pain relief by blocking ventral and dorsal rami along with lateral cutaneous branches of the intercostal nerves.Another block ,Serratus anterior muscle (SAM) block described by Blanco has also been advocated to provide pain relief by virtue of blocking lateral cutaneous branches of thoracic intercostal nerves. In SAM block, LA is injected in between lattisimus dorsi and serratus anterior muscle. There are very few studies in the literature where ESP block has been used to provide post-operative analgesia in MRM parients . Hence the present study has been designed to compare these two regional anesthetic techniques and their effectiveness in controlling post-operative pain in patients scheduled to undergo MRM.
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