| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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
|
|
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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. |