| CTRI Number |
CTRI/2018/07/014932 [Registered on: 18/07/2018] Trial Registered Prospectively |
| Last Modified On: |
17/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check Effectiveness of 2 chloroprocaine and bupivacaine for short duration Infraumbilical surgeries |
|
Scientific Title of Study
|
2-chloroprocaine and bupivacaine for infraumbilical short duration surgeries : a prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raviraj Dhondiram Kamble |
| Designation |
senior resident |
| Affiliation |
Government Medical College, Miraj |
| Address |
Operation Theater, room no.2, first floor, civil hospitals, sangli.
Sangli
MAHARASHTRA
416416
India |
| Phone |
8983399475 |
| Fax |
|
| Email |
drraviraj.mdanaesthesia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raviraj Dhondiram Kamble |
| Designation |
senior resident |
| Affiliation |
Government Medical College, Miraj |
| Address |
Operation Theater , room no. 2, first floor , civil hospital, sangli.
Sangli
MAHARASHTRA
416416
India |
| Phone |
8983399475 |
| Fax |
|
| Email |
drraviraj.mdanaesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raviraj Dhondiram Kamble |
| Designation |
senior resident |
| Affiliation |
Government Medical College, Miraj |
| Address |
Operation Theater , room no 2, first floor , civil hospital , sangli.
Sangli
MAHARASHTRA
416416
India |
| Phone |
8983399475 |
| Fax |
|
| Email |
drraviraj.mdanaesthesia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Padmabhushan vasantdada patil government hospital , south shivaji nagar, sangli 416416 |
|
|
Primary Sponsor
|
| Name |
Dhondiram Dadu Kamble |
| Address |
100 feet road behind New MSEB appasaheb patil nagar abasaheb niwas sangli |
| Type of Sponsor |
Other [family person ] |
|
|
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 Raviraj Dhondiram Kamble |
civil hospital |
PVP Govt.Hospital, Department of Anaesthesiology,1st floor, main building , OT No.1 and 2, Sangli 416416
Sangli
MAHARASHTRA |
8983399475
drraviraj.mdanaesthesia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee Government Medical College and Hospital Miraj and PVPGH sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Infraumbilical short duration surgery , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 chloroprocaine |
Very short acting local anaesthetic drugs used for central neuraxial block
1% isobaric drug
3.5 cc volume |
| Intervention |
Bupivacaine |
0.5 % Hyperbaric drug
Long acting local anaesthetic agent
Central neuraxial (intrathecal) administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Weight 50 to 70 kg
ASA GRADE 1 AND 2 |
|
| ExclusionCriteria |
| Details |
Spine deformities
Prolonged major surgeries
Coagulation abnormalities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of anaesthesia an restriction of movement |
End of surgery
At 1.5 hrs after giving spinal
2 hrs
2.5 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Any complications like urinary retension
Transient Neurological Symptoms |
6 hrs after surgery
10 hrs after surgery
10th day
At end of 3rd month |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/08/2018 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1.Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, et al. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Canadian Journal of Anaesthesia 2011;58:384–91
2. Maes S, Laubach M, Poelaert J. Randomised controlled trial of spinal anaesthesia with bupivacaine or 2-chloroprocaine during caesarean section. Acta Anaesthesiologica Scandinavica 2016;60(5):642–9. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Spinal anaesthesia is safe and reliable technique for surgeries of lower abdomen and lower limbs. Nevertheless, some of the characteristics may limit its use for umbilical surgeries, including delayed ambulation, risk of urinary retention. So the choice of local anaesthetic is crucial in ambulatory settings. Short acting local anaesthetic may therefore represent a valid alternative like preservative free isobaric 2 chloroprocaine. Preservative free isobaric 2 chloroprocaine is shorter acting and without significant risk of Transient Neurological Symptoms with respect to hyperbaric lidocaine. The recovery is far earlier than bupivacaine and urinary retention is also not observed in most of the patients. Haemodynamic changes are also not much. So we think that chloroprocaine is better for short duration surgeries with better outcome.
|