| CTRI Number |
CTRI/2018/01/011593 [Registered on: 30/01/2018] Trial Registered Prospectively |
| Last Modified On: |
29/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
comparision of three doses of local anaesthetic Bupivacaine introduced into the spinal column of patients undergoing operation of the thigh and leg. |
|
Scientific Title of Study
|
Comparision of three doses of heavy Bupivacaine in spinal anaesthesia in patients undergoing lower extremity surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramapati Sanyal |
| Designation |
Associate Professor |
| Affiliation |
KPC Medical College |
| Address |
Deptt. of Anaesthesiology
KPC Medical College
1F Raja S C Mullick Road
Jadavpur
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830163182 |
| Fax |
|
| Email |
sanyalramapati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramapati Sanyal |
| Designation |
Associate Professor |
| Affiliation |
KPC Medical College |
| Address |
Deptt. of Anaesthesiology
KPC Medical College
1F Raja S C Mullick Road
Jadavpur
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830163182 |
| Fax |
|
| Email |
sanyalramapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramapati Sanyal |
| Designation |
Associate Professor |
| Affiliation |
KPC Medical College |
| Address |
Deptt. of Anaesthesiology
KPC Medical College
1F Raja S C Mullick Road
Jadavpur
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830163182 |
| Fax |
|
| Email |
sanyalramapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| KPC Medical College Jadavpur Kolkata |
|
|
Primary Sponsor
|
| Name |
Ramapati Sanyal |
| Address |
Deptt. of Anaestgesiology
KPC Medical College
1F Raja S C Mullick Road
Jadavpur
Kolkata 700032 |
| 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 |
| Ramapati Sanyal |
KPC Medical College |
Deptt. of Anaesthesiology
1F Raja S C Mullick Road
Jadavpur
Kolkata 700032
Kolkata
WEST BENGAL |
9830163182
sanyalramapati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1 and 2 undergoing lower limb surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
spinal anaesthesia |
three different doses of heavy bupivacaine 0.5% |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
Undergoing lower limb surgery. |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Anatomically distorted spine.
Spine surgery.
Surgery extending beyond 3 hrs.
Patients with perioperative complications.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in pulse systolic diastolic and mean blood pressure
Time to first analgesic requirement. |
2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recession of sensory and motor block using two segment recession time and modified Bromage scale respectively. |
4 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/01/2018 |
| 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="2"
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
|
Spinal anaesthesia is the anaesthesia of choice in adults undergoing lower limb surgery,provided there is no significant co-morbidity. But spinal anaesthesia can cause hypotension , bradycardia and prolonged immobilisation which can be harmful and distressing to the patient. The aim of the present study was to compare three different doses of bupivacaine for lower limb surgery in sixty ASA grade 1 and 2 patients aged 18 to 80 yrs of age. The parameters used will be systolic, diastolic and mean blood pressure and pulse rate. The secondary parameters will be recession of sensory and motor block at 2 hours using two dermatomal recession and modified bromage scale. |