| CTRI Number |
CTRI/2020/06/025611 [Registered on: 04/06/2020] Trial Registered Prospectively |
| Last Modified On: |
03/06/2020 |
| 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
|
Comparison of efficacy of erector spinae plane block with paravertebral block for postoperative pain management in patients undergoing breast cancer surgeries |
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Scientific Title of Study
|
Comparison of efficacy of erector spinae plane block with paravertebral block for postoperative analgesia in patients undergoing breast cancer surgeries |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arjun Singh |
| Designation |
post graduate resident |
| Affiliation |
Safdarjung hospital and Vardhman Mahavir Medical College |
| Address |
Department of Anaesthesia and intensive care. Ground floor, main operation theatre building. Safdarjung hospital and Vardhman Mahavir Medical College, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9560316794 |
| Fax |
|
| Email |
arjun.mander95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Agrawal |
| Designation |
Specialist Grade 1 ( Anaesthesia) |
| Affiliation |
Safdarjung hospital and Vardhman Mahavir Medical College |
| Address |
Department of Anaesthesia and intensive care. Ground floor, main operation theatre building. Safdarjung hospital and Vardhman Mahavir Medical College, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arjun Singh |
| Designation |
post graduate resident |
| Affiliation |
Safdarjung hospital and Vardhman Mahavir Medical College |
| Address |
Department of Anaesthesia and intensive care. Ground floor, main operation theatre building. Safdarjung hospital and Vardhman Mahavir Medical College, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9560316794 |
| Fax |
|
| Email |
arjun.mander95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Safdarjung hospital and Vardhman Mahavir Medical College New Delhi India |
|
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Primary Sponsor
|
| Name |
Safdarjung hospital and Vardhman Mahavir Medical College New Delhi India |
| Address |
Department of Anaesthesia and intensive care Ground floor, main operation theatre building. Safdarjung hospital and Vardhman Mahavir Medical College New Delhi 110029, India |
| 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 |
| Arjun Singh |
Safdarjung Hospital and Vardhmann Mahavir Medical College New Delhi 110023 |
Department of Anaesthesia and Intensive Care . Ground floor, main operation theatre building, Safdarjung Hospital And Vardhman Mahavir Medical College New Delhi.
New Delhi
DELHI |
9560316794
arjun.mander95@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
USG guided erector spinae plane block in patients undergoing breast cancer surgeries |
ESP block will be placed with patient in lateral position with side to be operated towards up.
Under all aseptic conditions, using an ultrasound system , the linear array high frequency probe will be placed in a transverse orientation to identify the spinous process, lamina, and transverse process of 4th thoracic vertebra. The tip of the transverse process will be centred on the ultrasound screen, and the transducer will be rotated 90 degrees into a longitudinal orientation to obtain a parasagittal view.
The 3 layers of muscles will be identified as trapezius, rhomboidus major and erector spinae.
A 10cm long, 22 gauge echogenic needle will be inserted out of plane, to contact the transverse process. After hydro-dissecting the plane with normal saline, 21 ml of 0.5 precent ropivacaine with 1µg per kg of clonidine diluted to 1 ml ( making total volume of drug to 22ml) will be deposited deep to the erector spinae muscle , lifting it off the transverse process of t4 vertebra.
Heart rate, blood pressure (systolic, diastolic, mean), sp02 and etco2 will be monitored continuously in the intraoperative period and will be noted before administration of regional block and then after administration of regional block every 10 minutes for next 60 minutes and thereafter every 30 minutes till the end of surgery. Entropy will be used to monitor the depth of anaesthesia and will be maintained between 40 and 60 by adjusting the concentration of isoflurane. If there is any increase in hr or bp more than 20 percent baseline then intravenous injection fentanyl 0.5μg per kg will be given. Any hypotension ( fall in mean arterial pressure more than 20 percent of baseline) will be treated with boluses of ringer lactate solution and, if required with intravenous mephentermine 3 to 6 mg. Symptomatic bradycardia will be treated with intravenous atropine 0.6 mg. At the end of surgery 100 percent oxygen will be given to all the patients and residual neuromuscular blockade will be reversed with intravenous neostigmine 0.05mg per kg and glycopyrrolate 0.01mg per kg. On adequate neuromuscular reversal, the supraglottic airway device will be removed and patients will be shifted to the recovery room.
|
| Comparator Agent |
USG guided Paravertebral block in patients undergoing breast cancer surgery |
Patients will be kept in lateral position with the side to be operated up, on the operation table. under all aseptic conditions, using an ultrasound system , the linear array high frequency probe will be placed in a parasagittal plane , approximately 5 cm lateral to the spinous processes of t3 and t4 vertebrae to identify ribs, parietal pleura and intercostal spaces. The transducer is then moved progressively medially to about 2.5 cm lateral to spinous process to identify transverse processes of t3 and t4 vertebrae . Transverse processes appear square and deeper then ribs (round, superficial). The thoracic paravertebral space will be identified as a wedge shaped hypoechoic space between the superior costotransverse ligament and the pleura.
A 10 cm long, 22-gauge, echogenic needle will be inserted using an out of-plane approach to contact the transverse process and then walk off the transverse process 1 to 1.5 cm deeper to inject the local anaesthetic agent. During needle advancement, hydro-dissection will be used to locate the needle tip under ultrasound guidance, until the tip penetrates the superior costotransverse ligament. Penetration of the costotransverse ligament with the needle tip in the paravertebral space, will be confirmed by hydro-dissection technique by injecting normal saline and seeing anterior displacement of pleura. Negative aspiration for blood will be confirmed and 21 ml of 0.5 percent ropivacaine with 1µg per kg of clonidine diluted to 1 ml of saline ( making total volume of drug to 22 ml) will be injected in paravertebral space. Proper spread of the drug in the paravertebral space will be confirmed by anterior displacement of the pleura.
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
This study will be conducted in adult female patients of age 18 - 60 years weighing > 50 kgs, fulfilling criteria of American Society of Anaesthesiology (ASA) physical status i and ii undergoing elective modified radical mastectomy (MRM) for breast cancer under general anaesthesia with controlled ventilation. |
|
| ExclusionCriteria |
| Details |
1. coagulation disorder, local infection, allergy to study drugs
2. anatomic deformity of spine or chest wall
3. pregnant patient
4.morbid obesity
5. liver or renalinsufficiency, respiratory/ cardiac/ psychiatric disease.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Analgesia- time from administration of the block till time of administration of first rescue analgesia to the patient will be noted (primary objective). |
Preoperative vitals to be noted at time 0.
Intraoperative vitals to be noted at before block, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 mins after the block.
postoperative:
1. VAS assessment at 0,1,2,4,6.,12,24 hours
2. PONV score assessed at 0,6,12,24 hours. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1) Visual Analogue Scale (VAS)
2) Total intraoperative requirement of fentanyl
3) Total amount of tramadol required in first 24 hours postoperatively
4) Postoperative nausea and vomiting
5) Adverse effects if any
6) Patient satisfaction using numeric rating scale (nrs)
7) Number of dermatomal segments blocked postoperatively
|
VAS at 0,1,2,4,6,12,24 hours
Postoperative nausea and vomiting at 0,6,12,24 hours
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
09/06/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study is aimed at comparing the efficacy of erectoe spinae plane block with paravertebral block for postoperative pain relief in patients undergoing breast cancer surgery. Study will be conducted in adult females of age 18-60 years weighing>50 kgs fulfilling the criteria of ASA physical status I and II undergoing breast cancer surgery under general anaesthesia with controlled ventilation. Patient taken to O.T. and baseline parameters of HR, BP, SPO2 noted. Standard general anaesthesia administered, inj dexamethasone 0.1mg/kg given, inj paracetamol 1gm i.v. over 30 mins administered. Randomized into two groups: GROUP E (USG guided erector spinae block) in lateral position using 21 ml of 0.5% ropivacaine + clonidine 1mcg/kg made to total of 22ml. GROUP P(USG guided paravertebral block) in lateral position using 21ml of 0.5% ropivacaine +1 mcg/kg clonidine made to total of 22ml. Intraoperative fentanyl requirement to be noted Parameters to be noted after reversal: 1.Duration of analgesia 2.VAS score 3.Total tramadol requirement 4.PONV score 5.Patient satisfaction using NRS 6.Intraoperative fentanyl requirement |