CTRI Number |
CTRI/2024/02/063007 [Registered on: 21/02/2024] Trial Registered Prospectively |
Last Modified On: |
20/02/2024 |
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 the clinical features of drugs 0.75% ropivacaine and the combination of ropivacaine 0.75% with fentanyl 25 mcg for spinal anaesthesia in patients undergoing perianal surgeries |
Scientific Title of Study
|
A comparative study Of intrathecal (0.75%) Ropivacaine and (0.75%) Ropivacaine with Fentanyl in daycare perianal surgeries. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
ARUN KUMAR A BARASAKALE |
Designation |
POST GRADUATE RESIDENT |
Affiliation |
|
Address |
OT COMPLEX DEPARTMENT OF ANAESTHESIOLOGY,
DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL, KADUGONDANAHALLI, BANGALORE – 560045
Bangalore KARNATAKA 560045 India |
Phone |
7204602149 |
Fax |
|
Email |
arun.16evez@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr M SALIM IQBAL |
Designation |
PROFESSOR DEPARTMENT OF ANESTHESIOLOGY |
Affiliation |
DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL |
Address |
OT COMPLEX, DEPARTMENT OF ANAESTHESIOLOGY,
DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL, KADUGONDANAHALLI, BANGALORE – 560045
Bangalore KARNATAKA 560045 India |
Phone |
9964651079 |
Fax |
|
Email |
drsalim_iqbal@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
ARUN KUMAR A BARASAKALE |
Designation |
POST GRADUATE RESIDENT |
Affiliation |
DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL |
Address |
OT COMPLEX DEPARTMENT OF ANAESTHESIOLOGY,
DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL, KADUGONDANAHALLI, BANGALORE – 560045
Bangalore KARNATAKA 560045 India |
Phone |
7204602149 |
Fax |
|
Email |
arun.16evez@gmail.com |
|
Source of Monetary or Material Support
|
OT COMPLEX DEPARTMENT OF ANAESTHESIOLOGY,
DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL, KADUGONDANAHALLI, BANGALORE – 560045
|
|
Primary Sponsor
|
Name |
Dr ARUNKUMAR A BARASAKALE |
Address |
OT COMPLEX DEPARTMENT OF ANAESTHESIOLOGY,
DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL, KADUGONDANAHALLI, BANGALORE – 560045 |
Type of Sponsor |
Other [] |
|
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 |
DRARUNKUMAR A BARASAKALE |
DR.ARUNKUMAR. A. BARASAKALE |
OT COMPLEX DEPARTMENT OF ANAESTHESIOLOGY, DR.
B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL,
KADUGONDANAHALLI, BANGALORE – 560045
Bangalore
KARNATAKA Bangalore KARNATAKA |
7204602149
arun.16evez@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 |
(1) ICD-10 Condition: 8||Other Procedures, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Ropivacaine |
Spinal block characters |
Comparator Agent |
Ropivacaine with fentanyl |
Spinal block characteristics |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
a) Patients aged between 18 to 60 years of age posted for elective perianal
surgeries.
b) ASA grade I and II patient |
|
ExclusionCriteria |
Details |
a)Patients who has H/o coagulation and bleeding disorders.
b) Local site infections.
c) H/o hypersensitivity to study drugs. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1.Time taken for ambulation without assistance. |
24 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Time to achieve T10 sensory block
2.Maximum height of sensory block
3.Duration of sensory block
4.Duration of motor block |
24 HOURS |
|
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
|
Phase 1 |
Date of First Enrollment (India)
|
03/03/2024 |
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 Yet Recruiting |
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
|
Subarachnoid block (SAB) is most widely used regional anesthesia technique in the world. It is a reliable, quick, effective and safe technique with predictable benefits, and has been the procedure of choice for perianal surgeries unless contraindicated. The changing trend of surgical practice from an inpatient to outpatient has urged us to use short duration acting local anesthetic. An ideal anesthetic for spinal anesthesia in ambulatory surgery should provide rapid onset, adequate potency, predictable duration, decreased neurotoxicity along with minimal systemic side effects.The evidence for transient neurological symptoms (TNS) associated with the short-acting spinal anesthetic lidocaine has led to the use of alternative drugs such as bupivacaine, levobupivacaine or ropivacaine. Ropivacaine is the pure S enantiomer of propivacaine and is a amide local anaesthetic which is associated with a lower grade of motor block, a shorter duration of action than bupivacaine and a reduced potential for CNS and cardiac toxicity, making it a possible alternative to lidocaine for shorter outpatient procedures. The dose of local anesthetic can be reduced by the addition of adjuvant like opioids and alpha 2 adrenergic agonists. Subarachnoid fentanyl is known to provide rapid onset of analgesia, improve surgical blockade quality and enhance the effect of small doses of subarachnoid local anaesthetic. We hypothesise that addition of fentanyl to ropivacaine as neuraxial adjuvant improves the quality of spinal block and prolongs postoperative analgesia without significantly prolonging the time for ambulation without assistance. |