| CTRI Number |
CTRI/2025/05/086807 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
12/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of different doses of chlorprocaine for sphincterotomy surgery under spinal anaesthesia |
|
Scientific Title of Study
|
Comparison between intrathecal variable doses of chlorprocaine with fentanyl for LAS surgeries |
| 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 Krishna Chaitanya R |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College Kadapa |
| Address |
Department of Anaesthesia , Government Medical College Kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
9000886604 |
| Fax |
|
| Email |
dr.krishnachaitanyaraacherla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Chaitanya R |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College Kadapa |
| Address |
Department of Anaesthesia , Government Medical College Kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
9000886604 |
| Fax |
|
| Email |
dr.krishnachaitanyaraacherla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Chaitanya R |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College Kadapa |
| Address |
Department of Anaesthesia , Government Medical College Kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
9000886604 |
| Fax |
|
| Email |
dr.krishnachaitanyaraacherla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology , Government Medical College , Kadapa 516001 Andhra Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Krishna Chaitanya R |
| Address |
Assistant Professor, Department of Anaesthesiology ,Government medical college, Kadapa 516001 Andhra pradesh India |
| 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 Krishna Chaitanya R |
Government General Hospital |
Department of Anaesthesiology, Government General Hospital Kadapa
Cuddapah
ANDHRA PRADESH |
9000886604
dr.krishnachaitanyaraacherla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical college, Kadapa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorprocaine 20mg |
Intrathecal administration of single dose of 20mg of Chlorprocaine during spinal anaesthesia for study of Sensory and Motor blockade |
| Intervention |
Chlorprocaine 30mg |
Intrathecal administration of single dose of 30mg Chlorprocaine during spinal anaesthesia for study of Sensory and Motor blockade |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for Haemorrhoidectomy surgery under ASA Grade1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients with bleeding disorders, Allergic to Local Anaesthetics agents, Pregnant women, Patients on anticoagulants |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensory and Motor Blockade- Onset and Duration |
2,4,6,8,10 and 15minutes, then every 15 minutes for 6hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perioperative hemodynamics and Adverse effects |
2,4,6,8,10 and 15minutes, then every 15 minutes for 6hours, then every 2hrs for 12 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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
26/05/2025 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Hyperbaric Bupivacaine is used for intrathecal administration to provide Anaesthesia for Lateral anal sphincterotomy surgery which hinders the patient to be discharged on day care basis. Chlorprocaine is ideal agent due to short duration Sensory and Motor blockade , for intrathecal adminstration in such cases. This study is done with two different doses of intrathecal Chlorprocaine 20mg and 30mg. |