| CTRI Number |
CTRI/2025/09/094389 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of intrathecal 0.5 percentage hyperbaric bupivacaine with fentanyl versus buprenorphine in lower limb surgeries in tertiary care centre |
|
Scientific Title of Study
|
Comparative study of intrathecal hyperbaric bupivacaine 0.5 percentage with fentanyl versus buprenorphine in lower limb surgeries in tertiary care centre |
| 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 ANNAPOORANI MANOHAR |
| Designation |
POSTGRADUATE |
| Affiliation |
ACS MEDICAL COLLEGE & HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY ACS MEDICAL COLLEGE AND hospital DR M.G.R UNIVERSITY AND RESEARCH INSTITUTE(DEEMED UNIVERSITY) MADURAVOYAL CHENNAI
Chennai
TAMIL NADU
600077
India |
| Phone |
8110017092 |
| Fax |
|
| Email |
annaprn10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAMA S |
| Designation |
PROFESSOR |
| Affiliation |
ACS MEDICAL COLLEGE &HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY ACS MEDICAL COLLEGE AND hospital DR M.G.R UNIVERSITY AND RESEARCH INSTITUTE(DEEMED UNIVERSITY) MADURAVOYAL CHENNAI
Chennai
TAMIL NADU
600077
India |
| Phone |
9566823041 |
| Fax |
|
| Email |
drrama87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANNAPOORANI MANOHAR |
| Designation |
POSTGRADUATE |
| Affiliation |
ACS MEDICAL COLLEGE & HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY ACS MEDICAL COLLEGE AND hospital DR M.G.R UNIVERSITY AND RESEARCH INSTITUTE(DEEMED UNIVERSITY) MADURAVOYAL CHENNAI
Chennai
TAMIL NADU
600077
India |
| Phone |
8110017092 |
| Fax |
|
| Email |
annaprn10@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY ACS MEDICAL COLLEGE AND HOSPITAL TAMIL NADU CHENNAI 600077 |
|
|
Primary Sponsor
|
| Name |
ACS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY ACS MEDICAL COLLEGE AND HOSPITAL CHENNAI |
| 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 ANNAPOORANI MANOHAR |
ACS MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY ACS MEDICAL COLLEGE AND HOSPITAL
Chennai
TAMIL NADU |
8110017092
annaprn10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
lower limb surgeries |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SPINAL ANAESTHESIA |
study of intrathecal hyperbaric bupivacaine 0.5 PERCENTAGE with fentanyl in lower limb surgeries in tertiary care centre |
| Comparator Agent |
SPINAL ANAESTHESIA |
study of intrathecal hyperbaric bupivacaine o.5 percentage with buprenorphine IN LOWER LIMB SURGERIES |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA1 and ASA2 PATIENTS
ALL PATIENTS UNDERGOING ELECTIVE LOWER LIMB SURGERY UNDER SPINAL ANAESTHESIA
PATIENT BELONGING TO AGE GROUP 18-60 YEARS |
|
| ExclusionCriteria |
| Details |
ASA PHYSICAL STATUS MORE THAN ASA3 and ASA4
HISTORY OF ALLERGY TO FENTANYL,BUPRENORPHINE AND BUPIVACAINE
PATIENTS REFUSAL
PATIENT HAVING CONTRAINDICATIONS TO SPINAL ANAESTHESIA
PATIENT WITH HISTORY OF BLEEDING DISORDERS OR PATIENTS ON ANTICOAGULANTS
PATIENTS WITH INFECTION AT THE SITE OF INJECTION
PATIENT WITH INFECTION AT THE SITE OF INJECTION
PATIENTS WITH ALLERGY TO LOCAL ANAESTHETICS
PATIENTS WITH CARDIAC DISEASE,HEART BLOCK ,DYSRHYTHMIAS , ANEMIA,SEVERE HYPOVOLEMIA,SHOCK,SEPTICEMIA,AND NEUROLOGICAL DEFECTS
PATIENTS ON BETA BLOCKERS AND ALPHA BLOCKERS
ANATOMICAL ABNORMALITY AT THE REGIONAL SITE
PREGNANT WOMEN |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO NOTE THE EFFECTIVENESS OF INTRATHECAL FENTANYL ,BUPRENORPHINE AND BUPIVACAINEON CHARACTERISTICS OF SUBARACHNOID BLOCK |
TO NOTE THE EFFECTIVENESS OF INTRATHECAL FENTANYL ,BUPRENORPHINE AND BUPIVACAINEON CHARACTERISTICS OF SUBARACHNOID BLOCK AT THE TIME OF 1ST ONSET OF PAIN |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE DURATION OF POSTOPERATIVE ANALGESIA AS TIME FOR THE FIRST ONSET OF PAIN AND TO STUDY EFFECTS OF HEMODYNAMIC PARAMETERS AND VITALS PARAMETERS |
AT TIME OF 1ST ONSET OF PAIN |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
05/01/2026 |
| 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="2"
Months="0"
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
|
i randomised patients undergoing lower limb surgeries under spinal anaesthesia into two groups so as to receive intrathecal either buprenorphine and fentanyl and bupivacaine 0.5% hyperbaric and noted study parameters in equal periods of time benefits of participation intrathecal buprenorphine produces a more preferable prolonged sensory block and motor block than fentanyl and both groups hemodynamic stability was equal |