| CTRI Number |
CTRI/2020/02/023186 [Registered on: 07/02/2020] Trial Registered Prospectively |
| Last Modified On: |
06/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare chloroprocaine and bupivacaine in quick walking of patients after surgery |
|
Scientific Title of Study
|
A comparative study between chloroprocaine Vs bupivacaine in early ambulation of patient undergoing elective short durational surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Dhanasekar |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9176451198 |
| Fax |
|
| Email |
dr.dhanasekar89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S N Krishnamoorthy |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9786743120 |
| Fax |
|
| Email |
esenkeyem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Dhanasekar |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9176451198 |
| Fax |
|
| Email |
dr.dhanasekar89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram 503108 Tamil Nadu India |
|
|
Primary Sponsor
|
| Name |
S Dhanasekar |
| Address |
No 1268, 18th East cross street, MKB Nagar, Vysarpadi, Chennai 600039 |
| 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 |
| S Dhanasekar |
Shri Sathya Sai Medical College and Research Institute |
SURGERY OT Number 1 and 2 Second Floor OT Complex Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram 503108 Tamil Nadu India
Kancheepuram
TAMIL NADU |
9176451198
dr.dhanasekar89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K90-K95||Other diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine |
2ml of 0.5% Bupivacaine given in intrathecal route as a local anesthetic agent for subarachnoid block |
| Intervention |
Chloroprocaine |
2ml of 2% Chloroprocaine given in intrathecal route as a local anesthetic agent for subarachnoid block |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective short durational surgeries ( TURP, DJ Stenting, URSL, Perianal abscess, Gluteal abscess, LAS )
American Society of Anaesthesiologist I or II
Patient willing for regional anaesthesia and fear of general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient refusal for spinal anaesthesia
Coagulopathy or bleeding diathesis
Infection at the site of injection
Sepsis
Pre existing neurological deficit
Severe hypovolemia
Chronic renal disorder ( hypervolemia, acidosis, hypernatremia )
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for first / early mobilisation of patient |
Post Operative Period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of analgesia
Hemodynamic changes
Urinary retention
Transient neurological symptoms |
Post Operative Period |
|
|
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)
|
10/02/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomised controlled trial to evaluate the duration of analgesia, early mobilisation, analgesia efficacy, safety features of chloroprocaine with hyperbaric bupivacaine in short durational surgeries among 60 patients over a period of 18 months. The primary objective is to find the time taken for first / early mobilisation of patient post operatively. The secondary outcomes are duration of analgesia, hemodynamic changes, urinary retention, transient neurological symptom.
|