| CTRI Number |
CTRI/2018/07/014913 [Registered on: 17/07/2018] Trial Registered Prospectively |
| Last Modified On: |
16/07/2018 |
| 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 analgesic efficacy of two regional anaesthetic techniques in breast cancer surgery patients.
|
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Scientific Title of Study
|
Comparative evaluation of Ultrasound guided Serratus anterior plane block versus Erector spinae plane block for postoperative analgesia in modified radical mastectomy-A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepti Ahuja |
| Designation |
Senior Resident (DM Onco-Anesthesia) |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
Room no 139,
Ist Floor
Department of Onco-Anesthesia and Palliative Medicine,
Dr B.R.Ambedkar Institute Rotaory Cancer Hospital
South West
DELHI
110029
India |
| Phone |
9643623425 |
| Fax |
|
| Email |
deeptiahuja2252@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
Room no 139,
Ist Floor
Department of Onco-Anesthesia and Palliative Medicine,
Dr B.R.Ambedkar Institute Rotaory Cancer Hospital
South West
DELHI
110029
India |
| Phone |
8800824061 |
| Fax |
|
| Email |
vkchanpadia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Ahuja |
| Designation |
Senior Resident (DM Onco-Anesthesia) |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
Room no 139,
Ist Floor
Department of Onco-Anesthesia and Palliative Medicine,
Dr B.R.Ambedkar Institute Rotaory Cancer Hospital
DELHI
110029
India |
| Phone |
9643623425 |
| Fax |
|
| Email |
deeptiahuja2252@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oncoanesthesia and Palliative Medicine,
DrB.R.A IRCH
All India Institute of Medical Sciences ,New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
AIIMS,
ANSARI NAGAR,
NEW DELHI |
| Type of Sponsor |
Research institution and hospital |
|
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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 |
| Dr Deepti Ahuja |
AIIMS,New Delhi |
Room no.139
Department of Oncoanesthesia and Palliative Medicine,Dr B.R.A IRCH
South West
DELHI |
9643623425
deeptiahuja2252@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with clinical diagnosis of breast carcinoma posted for modified radical mastectomy, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block (ESPB) |
Patients in Group 2 will undergo Modified radical mastectomy under general anaesthesia along with ESPB block.Before induction of anaesthesia ESPB block will be given by injecting 0.4ml/kg of Inj. 0.375% Ropivacaine (with a maximum volume of 30ml)between erector spinae muscle and transverse process of fifth thoracic vertebrae in preoperative holding area. |
| Comparator Agent |
Serratus anterior plane block (SAP) |
Patients in Group 1 will undergo Modified radical mastectomy under general anaesthesia along with SAP block.Before induction of anaesthesia SAP block will be given by injecting 0.4ml/kg of 0.375% Ropivacaine (with a maximum volume of 30ml)between serratus anterior muscle and external intercostal muscle at the level of fifth rib in preoperative holding area. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.Female patients with carcinoma breast
2. Age group -18-70 years
3. ASA Physical status 1,2,3 scheduled to undergo modified radical mastectomy. |
|
| ExclusionCriteria |
| Details |
1.Patients Refusal
2.Patients with infection at the site of SAP or ESPB block
3.Patients with severe chest wall deformity
4.Patients with history suggestive of coagulopathy or receiving any anticoagulants
5.Presence of complications like mental illness, severe heart disease (NYHA classification ≥3)
6.Any renal or hepatic disorder before surgery 7.Allergic to any drug being used during the study.
|
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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 Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the time to first dose of rescue analgesic in the post-operative period in patients undergoing modified radical mastectomy under combined general anaesthesia and serratus anterior plane block with patients undergoing modified radical mastectomy under combined general anaesthesia and erector spinae plane block. |
To evaluate and compare the time to first dose of rescue analgesic at the time when numerical rating score more than 4 in the post-operative period in patients undergoing modified radical mastectomy under combined general anaesthesia and serratus anterior plane block with patients undergoing modified radical mastectomy under combined general anaesthesia and erector spinae plane block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a.To evaluate and compare the total dose of rescue analgesic needed intraoperatively.
b. To evaluate and compare the total dose of rescue analgesics required postoperatively.
c. To evaluate and compare the patient satisfaction score postoperatively.
|
The total intraoperative and postoperative analgesics and patients satisfaction scores will be noted till 24 hours after the surgery. |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2018 |
| 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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Breast cancer is the most common cancer found in women worldwide.Perioperative pain management is one of the crucial elements required for optimal outcome of patients undergoing breast cancer surgery.Various techniques like the wound infiltration, intravenous opioids, thoracic epidural and thoracic paravertebral have been used for postoperative pain management in these patients.Recently, fascial plane blocks are being increasingly employed for intraoperative and postoperative pain management in these patients.These fascial plane blocks include Modified Pectoralis nerve block, Serratus anterior plane block and Erector spinae plane block.Among all regional anaesthetic techniques, which is the most efficacious, safe, technically simple and less time consuming is questionable.No randomized clinical trial has been done to compare the analgesic efficacy of ESPB and SAP block.Hence we planned a prospective randomized clinical trial to compare the analgesic efficacy of SAP block and ESPB in patients undergoing modified radical mastectomy. |