| CTRI Number |
CTRI/2024/04/065646 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the clinical features of two drug combinations for injecting into backbone , such as ropivacaine 0.75% with fentanyl and ropivacaine 0.75% with morphine on patients undergoing day care surgeries in the anal region |
|
Scientific Title of Study
|
A comparative study of intrathecal (0.75%) ropivacaine with fentanyl and intrathecal (0.75%) ropivacaine with morphine in day care perianal 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 Shirley Paulina |
| Designation |
Senior resident |
| Affiliation |
DR B R Ambedkar medical college and hospital Bengaluru |
| Address |
Dept. of anesthesia
DR B R Ambedkar medical college and hospital Bengaluru 560045
Bangalore KARNATAKA 560045 India |
| Phone |
9482218232 |
| Fax |
|
| Email |
shirlzz7291@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shirley Paulina |
| Designation |
Senior resident |
| Affiliation |
DR B R Ambedkar medical college and hospital Bengaluru |
| Address |
Dept. of anesthesia
DR B R Ambedkar medical college and hospital Bengaluru 560045
Bangalore KARNATAKA 560045 India |
| Phone |
9482218232 |
| Fax |
|
| Email |
shirlzz7291@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shirley Paulina |
| Designation |
Senior resident |
| Affiliation |
DR B R Ambedkar medical college and hospital Bengaluru |
| Address |
Dept. of anesthesia
DR B R Ambedkar medical college and hospital Bengaluru 560045
Bangalore KARNATAKA 560045 India |
| Phone |
9482218232 |
| Fax |
|
| Email |
shirlzz7291@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR B R Ambedkar medical college and hospital Bengaluru 560045 |
|
|
Primary Sponsor
|
| Name |
Dr Shirley Paulina |
| Address |
Dept. of anesthesia
DR B R Ambedkar medical college and hospital Bengaluru 560045 |
| 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 Shirley Paulina |
DR B R Ambedkar Medical College Hospital KG halli Bengaluru |
OT complex, Department of anesthesia, Bangalore KARNATAKA |
9482218232
shirlzz7291@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr BR Ambedkar Medical College and Hospital |
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 |
| Comparator Agent |
ropivacaine with fentanyl |
1.5 ml of 11.25 mg of 0.75% ropivacaine with 0.5 ml of 25mcg of fentanyl given intrathecally. |
| Intervention |
ropivacaine with morphine |
1.5 ml of 11.25 mg of 0.75% ropivacaine with 0.1 ml of 100 mcg of morphine with 0.4 ml of normal saline given intrathecally. |
|
|
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) Infection at the site of spinal anesthesia
c) H/o hypersensitivity to study drugs.
d) Patients not giving consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of analgesia in each group. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time to achieve S1 sensory block
2.Degree of motor block
3.Time taken for ambulation without assistance.
4.Complications if any |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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 2 |
|
Date of First Enrollment (India)
|
20/04/2024 |
| 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="0" Months="6" 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
|
Subarachnoid block is a popular anaesthesia procedure practiced worldwide. It is a standard procedure for lower abdominal, lower limb and perianal surgeries. It is a more reliable, quick procedure, applicable in emergency surgeries. An ideal anaesthetic for spinal anaesthesia in ambulatory surgery should provide rapid onset, adequate potency, predictable duration, decreased neurotoxicity along with minimal systemic side effects. Ropivacaine has high pKa , low lipid solubility, it has great degree of sensory blockade and lesser duration of motor blockade compared to Bupivacaine. It also provides rapid sensorimotor dissociation. It is a favorable drug for day care surgeries. Adjuvants like Opioids when added to Ropivacaine have shown to prolong the duration analgesia after surgery. 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. Intrathecal morphine used as a ‘one-shot’ method provides several advantages as it is easy, cost-effective, and reliable, and technical failures are rare. The analgesic effects last for 20–48 h. Morphine results in cephalad spread, thereby increasing the area of analgesia. |