CTRI Number |
CTRI/2019/06/019579 [Registered on: 07/06/2019] Trial Registered Prospectively |
Last Modified On: |
09/06/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To compare the effect of erector spinae block under sedation and general anesthesia on postopertaive recovery in patients undergoing breast brachytherapy |
Scientific Title of Study
|
Single-injection ultrasound guided erector spinae block compared to general anaesthesia in in patients undergoing Accelerated Partial Breast Irradiation-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 |
NISHKARSH GUPTA |
Designation |
Associate Professor |
Affiliation |
AIIMS |
Address |
Department of Onco-Anesthesiology and Palliative Medicine
Room no. 139, 1st floor, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS, New Delhi
DELHI
110029
India
South DELHI 110029 India |
Phone |
09013310014 |
Fax |
|
Email |
drnishkarsh@rediffmail.com |
|
Details of Contact Person Scientific Query
|
Name |
NISHKARSH GUPTA |
Designation |
Associate Professor |
Affiliation |
AIIMS |
Address |
Department of Onco-Anesthesiology and Palliative Medicine
Room no. 139, 1st floor, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS, New Delhi
DELHI
110029
India
South DELHI 110029 India |
Phone |
09013310014 |
Fax |
|
Email |
drnishkarsh@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
NISHKARSH GUPTA |
Designation |
Associate Professor |
Affiliation |
AIIMS |
Address |
Department of Onco-Anesthesiology and Palliative Medicine
Room no. 139, 1st floor, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS, New Delhi
DELHI
110029
India
110029
India South DELHI 110029 India |
Phone |
09013310014 |
Fax |
|
Email |
drnishkarsh@rediffmail.com |
|
Source of Monetary or Material Support
|
Department of Onco-Anesthesiology and Palliative Medicine, DRBRAIRCH,AIIMS |
|
Primary Sponsor
|
Name |
AIIMS New Delhi |
Address |
Room No 139, 1st floor, Dr B.R.A. Institute Rotary Cancer Hospital, AIIMS, Delhi, 110029 |
Type of Sponsor |
Research institution and hospital |
|
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 |
Nishkarsh Gupta |
Department of Onco-Anesthesiology and Palliative Medicine |
Room No 139, DRBRAIRCH, AIIMS
New Delhi
DELHI South DELHI |
9013310014
drnishkarsh@rediffmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committee (AIIMS) |
Approved |
|
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 ESPB |
Accelerated Partial Breast Irradiation under MAC along with ESPB block using 0.5% Ropivacaine (with a maximum volume of 30ml). |
Comparator Agent |
Group GA |
Accelerated Partial Breast Irradiation under general anaesthesia |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Female |
Details |
Clinical diagnosis of early stage breast cancer for APBI.
ASA Physical status I, II, III
|
|
ExclusionCriteria |
Details |
a. Patients Refusal
b. Patients with infection at the site of ESPB.
c. Patients with severe chest wall deformity.
d. Patients with history suggestive of coagulopathy or receiving any anticoagulants.
e. Presence of complications like mental illness, severe heart disease (NYHA classification ≥3), any renal or hepatic disorder before surgery. f. Allergic to any drug being used during the study.
|
|
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 |
Discharge from PACU as assessed by PADSS more than equal to 9 after end of surgery. |
Discharge from PACU as assessed by PADSS more than equal to 9 at regular intervals time 0,1,2,4 hrs. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Postoperative pain VAS score
Postoperative Nausea vomiting( VAS score 30 mm)
Sore throat.
Analgesic medication
Antimemetic medication
Oxygen supplementation
Hemodynamic and respiratory profiles
Satisfaction score |
At time zero,30 minutes, and 1,2,8 and 24 hrs after completion of surgery. |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
10/06/2019 |
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)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
NA |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Breast cancer is a
worldwide problem, accounting for 10.4% of all cancer incidence among women,
making it the second most common type of non-skin cancer (after lung cancer)
and the fifth most common cause of cancer death. The ‘surveillance, epidemiology and
end results’ (SEER) program reported that in 2006, 60% of diagnosed breast
cancers are early stage. The management of early-stage
breast cancer includes breast-conserving
surgery (such as lumpectomy), a mastectomy (also called a modified radical
mastectomy), radiation therapy and systemic treatments.
Despite the
advantages of BCT, its utilization remains a problem due to convenience, access, cost and other logistical issues. In APBI, radiation can be
delivered in a significantly shortened period, thereby potentially making the
BCT option available and attractive to more women. APBI can be done under
either local anaesthesia, general anaesthesia or regional blocks with sedation.
Breast cancer surgery, such as mastectomy or lumpectomy with or without
axillary lymph node dissection/biopsy, has frequently been performed using
general anesthesia (GA). However, GA is associated with a high incidence of postoperative
nausea and vomiting (PONV) that not only reduces patient satisfaction but also
delays patient recovery after breast surgery. Recently,
breast cancer surgery has often been performed under regional anesthesia
techniques like Paravertebral block (PVB), erector spinae block etc. A
recent metaanalysis demonstrated that thoracic PVB has several advantages, such
as better postoperative pain control, lower incidence of PONV, shorter recovery
time and higher patient satisfaction, compared with GA alone in breast surgery. To our knowledge, however, there are no reports of studies comparing GA with
Erector Spinae block for Accelerated Partial Breast Irradiation. The first
purpose of this study is to compare these two anesthesia techniques in
terms of post-anesthesia recovery time. Our secondary aim was to compare perioperative
hemodynamics because decreasing blood pressure is often observed during GA. We
hypothesized that performing the procedure under Erector Spinae block could facilitate postoperative
recovery and avoid hypotension during anesthesia. |