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CTRI Number  CTRI/2025/03/081768 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 04/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   patient satisfaction in breast surgeries 
Scientific Title of Study   Evaluation of quality of recovery with isobaric segmental spinal anesthesia versus general anesthesia in breast surgeries-A randomized controlled 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  Dr CH Rama Krishna Prasad  
Designation  Associate professor 
Affiliation  All India Institute of Medical Sciences Bibi Nagar 
Address  Dept. of Anesthesiology, All India Institute of Medical Sciences Bibi Nagar Hyderabad Metropolitan Region

Nalgonda
TELANGANA
508126
India 
Phone  9885718133  
Fax    
Email  ramakrishna.chikkala19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep G 
Designation  Associate professor 
Affiliation  All India Institute of Medical Sciences Bibi Nagar 
Address  Dept. of Anesthesiology, All India Institute of Medical Sciences Bibi Nagar Hyderabad Metropolitan Region

Nalgonda
TELANGANA
508126
India 
Phone  9989421851  
Fax    
Email  drsandeep189@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep G 
Designation  Associate professor 
Affiliation  All India Institute of Medical Sciences Bibi Nagar 
Address  Dept. of Anesthesiology, All India Institute of Medical Sciences Bibi Nagar Hyderabad Metropolitan Region

Nalgonda
TELANGANA
508126
India 
Phone  9989421851  
Fax    
Email  drsandeep189@gmail.com  
 
Source of Monetary or Material Support  
room no: 50, dept of anaesthesia, All India Institute of Medical Sciences, Bibinagar, hyderabad, telangana, india. pin:508126 
 
Primary Sponsor  
Name  All India Institute of Medical SciencesBibinagar 
Address  room no: 50, dept of anaesthesia, All India Institute of Medical Sciences Bibi Nagar Hyderabad Metropolitan Region Telangana.india. pin:508126 
Type of Sponsor  Government medical college 
 
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 CH Rama Krishna Prasad  All India Institute of Medical Sciences, Bibi Nagar  Room number G35 and G36, Operation Theater Complex, Department of Anesthesiology, All India Institute of Medical sciences, Bibi Nagar, Hyderabad Metropolitan Region
Nalgonda
TELANGANA 		 9885718133

ramakrishna.chikkala19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(AIIMS BBN-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General Anesthesia for patient posted for breast surgeries  Patients will be induced with fentanyl 2mcg/kg, propofol 1-2mg/kg, paralyzed with atracurium 0.5mg/kg will be given and maintained under isoflurane at 1MAC. duration of spinal procedure will be 5 mins 
Intervention  Segmental spinal anesthesia for patient posted for breast surgeries  Segmental spinal anesthesia will be performed T5-T6 intervertebral level using a 27G Whitacre needle with 10mg isobaric levobupivacaine and 25mcg fentanyl duration of spinal procedure will be 5 mins 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  ASA I,II
Breast surgeries 
 
ExclusionCriteria 
Details  Known allergy to the test drugs
Known difficult airway
hepatic disease, renal disease
Chronic alcoholic
Surgeries with expected duration more than 3hours 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patient satisfaction score will be evaluated in both the groups using quality of recovery 15(QOR15) questionnaire  Patient satisfaction score will be evaluated in both the groups using quality of recovery 15(QOR15) questionnaire on the next day of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of cardiorespiratory and respiratory parameters for both groups  Blood pressure(systolic, diastolic and mean), Heart rate and oxygen saturation (SPO2) will be evaluated every 3minutes up to 15minutes and every 5mins till the end of surgery 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   24/03/2025 
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)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   General anesthesia is routinely used technique for breast cancer surgery. However , the associated higher stress response, higher incidence of nausea, vomiting and increased length of hospitalization. Regional anesthesia can attenuate surgical stress response and provide better analgesia with reduction in postoperative opioid consumption. Blocking of the required dermatomes essential for the proposed surgery could be provided by thoracic segmental spinal anesthesia with low doses of local anesthetic. In this study we observe the postoperative recovery after the procedure to find out the best possible mode of anesthesia. We hypothesize that isobaric segmental spinal provides better quality of recovery compared to general anesthesia and less opioid consumption. In this study we aim to evaluate the QOR15 score, hemodynamics with isobaric segmental spinal anesthesia versus general anesthesia. 
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