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CTRI Number  CTRI/2022/12/048040 [Registered on: 13/12/2022] Trial Registered Prospectively
Last Modified On: 03/12/2022
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 block effects between heavy and plain ropivacaine in patients undergoing breast surgery under segmental thoracic spinal block 
Scientific Title of Study   Comparison of block characteristics and outcomes of hyperbaric versus isobaric ropivacaine in patients undergoing modified radical mastectomy under segmental thoracic spinal anaesthesia: An exploratory double blind randomized control 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 Preeti 
Designation  Post graduate student 
Affiliation  All India Institute of Medical Sciences Rishikesh 
Address  Department of Anaesthesiology, AIIMS Rishikesh,Virbhadra Road,Rishikesh Dehradun Uttranchal 249203

Dehradun
UTTARANCHAL
249203
India 
Phone  8901107101  
Fax    
Email  grover.preeti9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Praveen Talawar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Rishikesh 
Address  Department of Anaesthesiology, AIIMS Rishikesh,Virbhadra Road,Rishikesh Dehradun Uttranchal 249203

Dehradun
UTTARANCHAL
249203
India 
Phone  9654162941  
Fax    
Email  praveenrt64@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Praveen Talawar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Rishikesh 
Address  Department of Anaesthesiology, AIIMS Rishikesh,Virbhadra Road,Rishikesh Dehradun Uttranchal 249203

Dehradun
UTTARANCHAL
249203
India 
Phone  9654162941  
Fax    
Email  praveenrt64@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Rishikesh 
 
Primary Sponsor  
Name  Department of Anaesthesiology, AIIMS Rishikesh 
Address  Department of Anaesthesiology, AIIMS Rishikesh,Virbhadra Road,Rishikesh Dehradun Uttranchal 249203 
Type of Sponsor  Research institution and hospital 
 
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 Praveen Talawar  All India Institute of Medical Sciences , Rishikesh  Department of Anaesthesiology, AIIMS Rishikesh,Virbhadra Road,Rishikesh Dehradun Uttranchal 249203
Dehradun
UTTARANCHAL 
9654162941

praveenrt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Segmental thoracic spinal anaesthesia  Segmental thoracic spinal anaesthesia at T5-T6 level in patients undergoing modified radical mastcectomy of duration less than 3 hours. 
Comparator Agent  Group I - Isobaric ropivacaine for segmental thoracic spinal anaesthesia at T5-T6 level   Segmental thoracic spinal anaesthesia at T5-T6 level with 1ml of 0.75% isobaric ropivacaine + 25ug fentanyl in patients undergoing modified radical mastcectomy of duration less than 3 hours. 
Comparator Agent  Group II: Hyperbaric ropivacaine for segmental thoracic spinal anaesthesia at T5-T6 level  Segmental thoracic spinal anaesthesia at T5-T6 level with 1ml of 0.75% hyperbaric ropivacaine + 25ug fentanyl in patients undergoing modified radical mastcectomy of duration less than 3 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1) Female patients with breast cancer undergoing unilateral modified radical mastectomy with axillary clearance with duration less than 3 hours.
2) Age >20 years
3) ASA grading, I-III
4) BMI- 20-30 kg/m2
 
 
ExclusionCriteria 
Details  1) Refusing to participate in study.
2) Any contraindications to sub-arachnoid block.
3) Significant cardiovascular/renal/hepatic disease.
4) Hypersensitivity to any of the study drug
5) Breast reconstructive surgery with muscle flap
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time (onset) to achieve sensory loss at T2 level in both the groups  5,10,15 minutes of spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
Intra-operative outcome- Monitoring of Hemodynamics changes   From 0 to every 5 minutes till the end of surgery 
Post-operative outcome - Post-operative pain score according to NRS scale  At 0/2/6/12/18/24 hours 
 
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" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/12/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No publications till date 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Studies available in the epidemiological field have shown that the incidence of breast cancer is increasing with increase in age. The incidence is increasing most likely due to the widespread prevention campaigns and availability of modern diagnostic tools. Presently general anaesthesia is the standard technique used for surgical treatment of breast cancer. Nevertheless, the associated higher stress response, lack of residual analgesia, higher incidence of nausea and vomiting and increasing length of hospitalization demand for an alternative technique. 

Additionally, associated major medical problems are higher in these geriatric age group of patients, which makes regional anaesthesia a preferable option.

The regional anaesthesia techniques can reduce the surgical stress response and can come up with better analgesia with reduction in opioid consumption postoperatively. Moreover, local anaesthetics have direct protective action on cancer cell migration.

Conventionally used regional anaesthesia techniques for breast cancer surgery include thoracic epidural and thoracic paravertebral block. These regional techniques are very productive in the aspect of breast surgery, yet the delayed onset of block, patchy sensory block and large volume of local anaesthetic consumption with the likely local anaesthetic toxicity are even now concerned issues when applying these techniques during breast surgery. 

The blocking of the required dermatomes needed for the proposed surgery could be provided by thoracic segmental spinal anaesthesia with an exceedingly low dose of local anaesthetic. The patients will be having motor control over the limbs, which reduces anxiety and manifest a high level of satisfaction. 

Thomas Jonnesco (1909) introduced to the world the use of general spinal anaesthesia for surgeries of entire body including the skull, head, neck, and the thorax. The punctures were made at a level of spinal column appropriate to the region to be operated upon. Anaesthetic agent used was stovaine solution with addition of strychnine. They conducted high dorsal analgesia in 103 patients for operations in skull, face, Throat, thorax and upper limb. For head and neck procedures, punctures were performed between the 1st and the 2nd thoracic vertebrae, which resulted in good analgesia for the head, neck, and upper limbs. In thoracic area, high dorsal spinal anaesthesia was given for cases such as large extirpation in cancer breast, amputation of breast with extirpation of the axillary gland, extirpation in cystic disease of breast and resection of ribs.

Elakany MH et al, conducted a trial of segmental spinal anaesthesia in patients undergoing breast cancer surgeries and came to the conclusion that segmental spinal anaesthesia has some advantages over general anaesthesia in terms of patient satisfaction, post-operative analgesia, immediate post-operative recovery. 

Paliwal N et al, conducted a trial of segmental thoracic spinal anaesthesia versus general anaesthesia for breast cancer surgery. Author concluded that segmental thoracic spinal anaesthesia provides better satisfaction with better post-operative analgesia & fewer complications as compared to GA.

Mahmoud AAA et al, conducted a feasibility study where he used segmental thoracic spinal anaesthesia at T5 level in healthy patients undergoing breast surgery and concluded that segmental spinal anaesthesia can be used successfully in these patients with minimum hemodynamic instability.

Most important risk factors for post-operative morbidity & mortality are increasing age & associated comorbidities which have been a great challenge to provide perioperative care to the elderly patients. Also, routine use of GA in major surgeries is responsible for increased perioperative complications. Regional anaesthesia (RA) techniques especially neuraxial blockade can improve recovery & minimize adverse effects and perioperative complications. Potential benefits of using neuraxial blockade include decreased cardio-respiratory complications, decreased neuroendocrine response to surgical stress stimuli, better perioperative care & faster recovery of the patient with less incidence of postoperative nausea & vomiting (PONV), prevention of thromboembolic events & early patient mobilization.

Segmental thoracic spinal anaesthesia (STSA), because it is highly selective spinal block has more advantages like better control at the time of both induction & surgical anaesthesia with increased sensory and motor blockade, better cardio-respiratory stability & less requirement of local anaesthetics with reduced risk of toxicity as compared to other RA procedures like lumbar spinal anaesthesia & thoracic paravertebral block (TPVB). 

 

The current literature review shows only isobaric local anaesthetics have been used in segmental thoracic spinal anaesthesia for breast cancer surgery, the isobaric local anaesthetic drugs are known to produce delayed onset of block with diffuse spread of spinal anaesthesia.

 

The aim of the current study is to compare block characteristics and outcomes of hyperbaric versus isobaric ropivacaine in patients undergoing unilateral modified radical mastectomy under segmental thoracic spinal anaesthesia in female patients.

 

 

 


 
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