| CTRI Number |
CTRI/2020/06/025677 [Registered on: 08/06/2020] Trial Registered Prospectively |
| Last Modified On: |
01/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of three different doses of Chloroprocaine drug on spinal anesthesia urology surgical procedures |
|
Scientific Title of Study
|
The effect of three different doses of Chloroprocaine 1% on spinal
anaesthesia in short duration elective urology surgical procedures– A randomized controlled trail. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kavya D C |
| Designation |
MD Anesthesiology (Post Graduate Resident) |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam
Madagadipet
Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9980182656 |
| Fax |
|
| Email |
kavyadoddamane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwanath R Hiremath |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam
Madagadipet
Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9442934258 |
| Fax |
|
| Email |
vishwanath0506@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishwanath R Hiremath |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam
Madagadipet
Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9442934258 |
| Fax |
|
| Email |
vishwanath0506@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Kavya D C |
| Address |
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam
Madagadipet
Puducherry
605107 |
| Type of Sponsor |
Private medical college |
|
|
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 Kavya D C |
Sri Manakula Vinayagar Medical College and Hospital |
Department of anesthesia
urology ot complex
Pondicherry
PONDICHERRY |
9980182656
kavyadoddamane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chloroprocaine |
1%, 20mg on spinal anaesthesia |
| Comparator Agent |
Chloroprocaine |
1%, 30mg on spinal anaesthesia |
| Comparator Agent |
Chloroprocaine |
1%, 40mg on spinal anaesthesia |
| Intervention |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) physical status I , II and III
BMI <35
Patients undergoing subarachnoid block in elective urological surgeries lasting for less
than 60 minutes. |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with local infection at site of injection
Patients with known or ascertained hypersensitivity to local anaesthesia
Patient with coagulopathy, bleeding disorders and/or on treatment with anticoagulants
History of neurological/psychiatric diseases
Pregnant women and lactating women
|
|
|
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 |
To compare the efficacy of intrathecal Chloroprocaine (1%) in three different doses for urology
surgical procedures. |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the time taken for the onset of sensory block |
1.5 years |
| To estimate the time taken for onset of motor block |
1.5 years |
| To estimate the time taken for readiness for surgery by achieving maximum sensory and motor blockade which can be known by pinprick sensation and Bromage scale more than or equal to 2 at the required metameric more than equal to T12 |
1.5 years |
| To estimate the time taken for unassisted ambulation which is a discharge criteria of patient from the hospital |
1.5 years |
| To estimate the time taken for first postoperative analgesia |
1.5 years |
|
|
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)
|
08/06/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Spinal anaesthesia has advantage over general anesthesia as it avoids problems associated with intubation, postoperative nausea and vomiting, delayed postoperative oral intake by the patient and increased duration of hospital stay for the patient. Spinal anaesthesia is usually carried out with available local anesthetic agents like lignocaine and bupivacaine. Transient Neurologic Symptoms (TNS) is reported with lignocaine and with bupivacaine there is delay in the recovery of the motor block after anaesthesia and hence has prolonged time for regression of the level of anaesthesia which can delay the mobility of the patient thereby delaying the hospital discharge. Chloroprocaine has rapid onset of action and rapid offset and less complications. Considering the above benefits it can be used in short duration urology surgical procedures. Hence helpful in day care surgeries which reduce the cost, enhances early ambulation and early discharge of patients from the hospital. |