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CTRI Number  CTRI/2024/05/066859 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 26/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Different technique of anesthesia for breast cancer surgery-Segmental thoracic spinal anesthesia versus general anesthesia. Which is better in terms of patients and surgeons?  
Scientific Title of Study   Segmental thoracic spinal anesthesia versus general anesthesia for breast cancer surgery – a prospective randomized comparative study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ruchi Saxena 
Designation  Assistant professor 
Affiliation  Kalyan Singh Superspeciality Cancer Institute 
Address  Department of Anesthesia, Kalyan Singh Superspeciality Cancer Institute, C.G.City, Sultanpur road, Lucknow

Lucknow
UTTAR PRADESH
226002
India 
Phone  09140366422  
Fax    
Email  taru_ruchi@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Ruchi Saxena 
Designation  Assistant professor 
Affiliation  Kalyan Singh Superspeciality Cancer Institute 
Address  Department of Anesthesia, Kalyan Singh Superspeciality Cancer Institute, C.G.City, Sultanpur road, Lucknow

Lucknow
UTTAR PRADESH
226002
India 
Phone  09140366422  
Fax    
Email  taru_ruchi@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Ruchi Saxena 
Designation  Assistant professor 
Affiliation  Kalyan Singh Superspeciality Cancer Institute 
Address  Department of Anesthesia, Kalyan Singh Superspeciality Cancer Institute, C.G.City, Sultanpur road, Lucknow

Lucknow
UTTAR PRADESH
226002
India 
Phone  09140366422  
Fax    
Email  taru_ruchi@yahoo.co.in  
 
Source of Monetary or Material Support  
Kalyan Singh Superspeciality Cancer Institute  
 
Primary Sponsor  
Name  Ruchi Sxaena 
Address  Kalyan Singh Superspeciality cancer institute, Lucknow, Uttar Pradesh 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Ruchi Saxena  Kalyan Singh Superspeciality cancer institute  OT Complex, Department of Anesthesia
Lucknow
UTTAR PRADESH 		 09140366422

taru_ruchi@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kalyan Singh Superspeciality Cancer Institute, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  general anesthesia  Routine general anesthesia will be given to patients undergoing breast cancer surgery randomized for this group. Duration last as per the surgery duration. 
Intervention  segmental thoracic spinal anesthesia (STSA)  STSA will be given to patients for breast cancer surgery randomized for this group duration of intervention usually last for 3-4 hours which is usually the surgical duration of the procedure followed by postoperative analgesia. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA physical status I-II patients.
Aged 20-65 years
Patients with primary breast cancer scheduled for unilateral mastectomy with axillary dissection.
 
 
ExclusionCriteria 
Details  1. Patient refusal,
2. Conditions contraindicating spinal anesthesia,
3. Inflammatory breast cancer,
4. Body mass index above 35kg/m2
5. Patients undergoing MRM with flap reconstruction
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Patient satisfaction score  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. Intraoperative hemodynamic changes.
2. Pain score at 1h, 4h,8h and 24 h after surgery.
3. Time to first rescue analgesia.
4. Total opioid consumption in first 24 h.
5. Peri operative complications like nausea, vomiting, pruritis and paraesthesia.
6. Discharge from PACU as per modified Aldrete score
7. Surgeon satisfaction score.
 		 24hours 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   13/05/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [taru_ruchi@yahoo.co.in].

  6. For how long will this data be available start date provided 14-05-2024 and end date provided 01-05-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

General anesthesia (GA) is considered to be the standard technique for breast cancer surgery. However, the associated higher stress response, higher incidence of nausea, vomiting and increasing length of hospitalization demand for an alternative technique. Regional anesthesia techniques can attenuate surgical stress response and provide superior analgesia, with higher patient satisfaction and lesser incidence of nausea, vomiting and reduction in postoperative opioid consumption. Since, patients have motor control over the legs, which decrease anxiety and exhibit a high level of satisfaction. Additionally, direct protective action of local anesthetics on cancer cell migration is also been observed. Also, it can have a long-term effect in decreasing complications such as chronic pain.

Few studies have assessed the efficacy of segmental thoracic spinal anesthesia (STSA) in laparoscopic cholecystectomy and breast cancer surgery with axillary lymph node clearance concluding that the technique could be a potential alternative to GA. So, we decided to study STSA as the sole regional anesthetic technique and to compare it with GA for breast cancer surgery.

We hypothesized that STSA could be a potential alternative to GA in patients undergoing breast cancer surgery.

 
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