| CTRI Number |
CTRI/2024/05/067143 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare two methods of perioperative pain relief in patients undergoing breast surgery |
|
Scientific Title of Study
|
Comparison between costotransvere block and erector spinae plane block for perioperative analgesia in patients undergoing modified radical mastectomy -A prospective randomised double blinded trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aanchal Bharuka |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Basavatarakam Indo-American Cancer Hospital and Research Institute,Hyderabad |
| Address |
Department of Onco-Anaesthesiology, Pain And Palliative Medicine, Basavatarakam Indo-American Cancer Hospital and Research Institute, Banjara Hills Road no 10, Hyderabad
Hyderabad TELANGANA 500034 India |
| Phone |
8978185520 |
| Fax |
|
| Email |
doc.aanchalb@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aanchal Bharuka |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Basavatarakam Indo-American Cancer Hospital and Research Institute,Hyderabad |
| Address |
Department of Onco-Anesthesiology, Pain and Palliative Medicine ,Basavatarakam Indo-American Cancer Hospital and Research Institute, Banjara Hills Road no 10, Hyderabad
Hyderabad TELANGANA 500034 India |
| Phone |
8978185520 |
| Fax |
|
| Email |
doc.aanchalb@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aanchal Bhrauka |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Basavatarakam Indo-American Cancer Hospital and Research Institute,Hyderabad |
| Address |
Department of Onco-Anesthesiology, Pain and Palliative Medicine, Basavatarakam Indo-American Cancer Hospital and Research Institute, Banjara Hills, Road no 10, Hyderabad
Hyderabad TELANGANA 500034 India |
| Phone |
8978185520 |
| Fax |
|
| Email |
doc.aanchalb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Basavatarakam Indo-American Cancer Hospital and Research Institute, Banjara Hills, Road no 10, Hyderbad -500034,Telangana, India |
|
|
Primary Sponsor
|
| Name |
Dr Aanchal Bharuka |
| Address |
Basavatarakam Indo-American Cancer Hospital and Research Institute, Banjara Hills, Road no 10, Hyderbad -500034,Telangana, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 |
| Dr Aanchal Bharuka |
Basavatarakam Indo-American Cancer Hospital and Research Institute |
Department of Onco-Anesthesiology, Pain and Palliative Medicine, Block 1, Fourth Floor, Basavatarakam Indo-American Cancer Hospital and Research Institute, Banjara Hills, Road no 10, Hyderabad -500034, Telangana, India Hyderabad TELANGANA |
8978185520
doc.aanchalb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BIACHRI |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Costo-transverse block |
A high frequency linear USG transducer will be placed 2-2.5cm lateral to the spinous process of the 4th thoracic vertebra. CTB block will be performed unilaterally on the ipsilateral side of surgery. The skin and subcutaneous layers, trapezius and erector spinae muscles, third and fourth transverse processes, intertransverse and superior costotransverse ligaments (SCTL) as well as the pleura will be placed in the field of view. A needle will be advanced parallel to the SCTL, will be stopped immediately before reaching the cranial part of the fourth rib. Here, 25ml 0.5% bupivacaine will be injected. In-plane technique will be used and the needle will be advanced cephalo-caudally. |
| Comparator Agent |
Erector spinae plane block |
A linear highâ€frequency US probe will be used for performing the block, which will be placed in craniocaudal orientation in the midline. The probe will then be moved laterally to identify T4 transverse process (TP), which is usually at 2.5–3 cm from spinous process laterally. ESM, rhomboidus major, and trapezius muscle will be identified.A 10 cm block needle will be introduced inâ€plane craniocaudally under vision and navigated till the TP is encountered. Hydro dissection with 2 ml normal saline will be done to confirm separation of ESM from TP. Under US guidance, 25ml 0.25 % bupivacaine will be injected and drug spread will be seen in the ESP plane craniocaudally in real time.
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 2 3
BMI LESS THAN 35
SURGERY MRM |
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL
AGE LESS THAN 25YEARS AND MORE THAN 65 YERAS
ASA 4
BMI MORE THAN 35
LOCAL ANESTHETIC ALLERY
INFECTION AT THE INFECTION SITE
COAGULOPATHY
RENAL DYSFUNCTION
HEPATIC DYSFUNCTION
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the analgesic efficacy for post operative pain management with respect to 24hr morphine consumptiom |
0,30,60,90,120 mins
4,6,8,12,16,20,24 hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.to assess and compare time required to perform the block
2.to assess and compare intraoperative hemodynamics - before ansd after skin incision
3.to assess and compare intraoperative fentanyl consumption
4.to assess and compare intraoperative complication between both groups |
before skin incision, after skin incision
30,60,90,120,150 mins |
|
|
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)
|
20/05/2024 |
| Date of Study Completion (India) |
20/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [doc.aanchalb@gmail.com].
- For how long will this data be available start date provided 01-10-2025 and end date provided 01-10-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
INTRODUCTION There is an increasing incidence of cancer and breast cancer is the most common cancer in women accounting to 25.8 per 100,000 women, in India1. Surgery remains the prime modality of treatment for these patients. About 10-20% of surgical patients experience acute post-operative pain, which may progress to post mastectomy pain syndrome in 25-60% patients if adequate pain relief is not provided2. Regional anesthesia techniques provide excellent perioperative analgesia 3and also reduce post-operative nausea, vomiting. Several regional anaesthesia techniques have been described for perioperative analgesia, however no single technique is proven better than the other. Erector spinae plane block and costo-transverse plane block are recent additions under US guided posterior thoracic blocks. Seelam et al used US guided ESPB for female patients undergoing modified radical mastectomy and evaluated its analgesic efficacy in reducing perioperative pain4. Nielsen et al in his cadaveric study, described US guided costo- transverse block as relatively new peri-paravertebral block. They checked for spread of injected dye in this block and erector spinae plane block5. The spread of local anaesthetic in costotransverse block involved better spread to ventral ramus than erector spinae plane block which possibly will give better analgesia. Methodology :After obtaining written informed consent computer generated randomization will be done. Patients will be randomized to receive either a singleâ€shot USâ€guided ESPB (ESP group) or single-shot US- guided costo transverse block After confirming nil by mouth status , patients will be wheeled in operation room and ASA standard monitors will be connected. General anaesthesia using iv Xylocard 1.5 mg/kg ,iv Fentanyl 2mcg/kg (ideal body weight ), iv Propofol 1.5 -2mg/kg.and neuromuscular block will be achieved with atracurium 0.5mg/kg. Airway will be secured with an appropriately sized Supraglottic airway/ ETT General anesthesia will be maintained with oxygen- medical air and Sevoflurane using volume controlled ventilation and dial concentration adjusted to target end tidal concentration of isoflurane of 1.2 .Dexamethasone 0.1mg/kg, iv Magnesium 40mgs/kg, iv Paracetamol 20mg/kg (maximum 1 gm) will be given after induction.as a part of multimodal analgesia. Post induction patients will be placed in lateral decubitus position and as per group allocated either US guided ESPB or US guided costo transverse block will be performed . Fentanyl 0.5 mcg/kg (maximum 50 mcg) will be administered to all the patients who have a sympathetic response to pain on incision i.e. if the heart rate and blood pressure is raised by at least 20% of baseline. Post extubation patient will be shifted to a highâ€dependency unit. The Numerical rating scale will be used to assess pain postoperatively. Intravenous paracetamol 1 g every 8 h will be continued in the postoperative period. Intravenous morphine will be used as rescue analgesic in both groups, if the NRS score was more than 4, 3mg iv morphine will be administered, and patient will be reassessed after 15 mins. If NRS is more than 4 a repeat dose of 3mg of morphine will be given. USâ€guided ESPB technique :A linear array highâ€frequency US probe (GE VENUE GO TM) will be used for performing the block, which will be placed in craniocaudal orientation in the midline. The probe will then be moved laterally to identify T4 transverse process (TP), which is usually at 2.5–3 cm from spinous process laterally. ESM, rhomboidus major, and trapezius muscle will be identified. Under aseptic precautions 10 cm block needle (Stimuplexï£¨ï€ Ultra 360ï£¨ï€ 22 G, Bâ€Braun) will be introduced inâ€plane craniocaudally under vision and navigated till the TP is encountered. Hydro dissection with 2 ml normal saline will be done to confirm separation of ESM from TP. Under US guidance, 25ml 0.5% bupivacaine will be injected and drug spread will be seen in the ESP plane craniocaudally in real time. USG guided CTB block :A high frequency linear USG transducer will be placed 2-2.5cm lateral to the spinous process of the 4th thoracic vertebra. CTB block will be performed unilaterally on the ipsilateral side of surgery. The skin and subcutaneous layers, trapezius and erector spinae muscles, third and fourth transverse processes, intertransverse and superior costotransverse ligaments (SCTL) as well as the pleura will be placed in the field of view. A needle will be advanced parallel to the SCTL, will be stopped immediately before reaching the cranial part of the fourth rib. In-plane technique will be used and the needle will be advanced cephalo-caudally. Here, 25ml 0.5% bupivacaine will be injected.
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