| CTRI Number |
CTRI/2020/01/023045 [Registered on: 30/01/2020] Trial Registered Prospectively |
| Last Modified On: |
27/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In this study a comparison is made between Conventional approach (L2L3 or L3L4, median route) & Taylors approach, (L5S1, paramedian route) of Spinal anaesthesia. |
|
Scientific Title of Study
|
To compare Taylors approach with conventional approach of spinal anaesthesia in elderly patients for gynaecological surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARI CHARAN |
| Designation |
JUNIOR RESIDENT, DEPARTMENT OF ANAESTHESIA |
| Affiliation |
IGMC, SHIMLA |
| Address |
JUNIOR RESIDENT, DEPARTMENT OF ANAESTHESIA, IGMC, SHIMLA (HP)
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418044409 |
| Fax |
|
| Email |
drhariuppal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PROF APARNA SHARMA |
| Designation |
ASSOCIATE PROFESSOR. |
| Affiliation |
IGMC, SHIMLA |
| Address |
ASSOCIATE PROFESSOR, DEPARTMENT OF ANAESTHESIA, IGMC, SHIMLA (HP)
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418044409 |
| Fax |
|
| Email |
aparnasharmaraina@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HARI CHARAN |
| Designation |
JUNIOR RESIDENT, DEPARTMENT OF ANAESTHESIA |
| Affiliation |
IGMC, SHIMLA |
| Address |
JUNIOR RESIDENT, DEPARTMENT OF ANAESTHESIA, IGMC, SHIMLA (HP)
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418044409 |
| Fax |
|
| Email |
drhariuppal@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR HARI CHARAN |
| Address |
JUNIOR RESIDENT, DEPARTMENT OF ANAESTHESIA, IGMC, SHIMLA (HP) |
| Type of Sponsor |
Other [Self] |
|
|
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 Hari Charan |
Kamla Nehru Hospital, Shimla (HP) |
Department of Anaesthesia, IGMC Shimla, (HP),171001
Shimla
HIMACHAL PRADESH |
9418044409
drhariuppal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, IGMC, SHIMLA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional approach of spinal anaesthesia- Spinal anaesthesia will be give through L2L3 OR L3L4 intervertebral space. |
Spinal Needle is introduced in the midline and directed slightly cephalad. Two pop ups are felt, one in supraspinous ligament and other in ligamentum flavum. the needle ia advanced to penetrate thew dura and then subarachanoid membrane as signalled by free flowing CSF. |
| Intervention |
Group A- Taylors Approach of spinal anaesthesia.
Group B- Conventional approach of spinal anaesthesia. |
Group A- Spinal anaesthesia will be given in L5S1 space through paramedian approach.
Group B- Spinal anaesthesia will be given in L2L3 OR L3L4 space through median approach. |
| Intervention |
Taylors approach of spinal anaesthesia. |
Taylors approach- Spinal anaesthesia will be given through L5S1 intervertebral space via paramedian route. Point of insertion of spinal needle is in cephalomedial direction through a skin wheal raised 1 cm medial and 1 cm caudal to the lowermost prominence of the posterior iliac spine. The posterior iliac spine may be located immediately anterior to the skin dimples often found overlying the superior aspect of sacrum. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
ASA physical status 1 or 2.
Patients who give valid informed written consent.
Patients scheduled for bow umbilicus gynaecological surgery. |
|
| ExclusionCriteria |
| Details |
Lack of valid informed written consent.
Infection at the subarachanoid block injection site.
Patients with neurological and musculoskeletal disease.
Patients with bleeding disorders.
Pregnancy.
History of allergy to local anaesthetic. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Number of attempts and time taken for lumbar puncture.
2. Incidence of hypotension.
3. Incidence of bradycardia. |
0, 5 minutes, 10 minutes, 30 minutes, 50 minutes, 70minutes, 90 minutes and 110minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Conversion rate to general anaesthesia. |
0,5 minutes, 10 minutes, 30 minutes, 50 minutes, 70 minutes, 90 minutes and 110 minutes. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Neuraxial anaesthesia is an indispensable and most commonly performed regional anaesthesia in modern anaesthetic pratice. It results in temporary interruption of nerve transmission within the subarachanoid space. An increasing proportion of of the patients undergoing gynaecological surgeries are elderly. Advancing age results in anatomical irregularities such as reduction in the number of neurons, deterioration of myelin sheaths, sclerotic closure of of the intervertebral foramens etc. Functional reserve and ability to compensate for physiological stresses are reduced. Spinal anaesthesia is more advantageous in these patients. Taylor’s approach which involves giving spinal anaesthesia through L5S1 intervertebral space via paramedian route encompasses less technical problems as compared to midline approach as it avoids the supraspinous and and interspinous ligaments. Also there are least haemodynamic changes as compared to conventional approach(L2L34and L3L4 space). |