| CTRI Number |
CTRI/2025/03/082317 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
02/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
use of additives intrathecally to enhance in post operative pain control management |
|
Scientific Title of Study
|
comparison of intrathecal hyperbaric bupivacaine 0.5% with morphine versus dexmedetomidine in infraumbilical 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 |
Afseen Fatima |
| Designation |
Junior Resident |
| Affiliation |
GMC Haldwani |
| Address |
2nd floor Department OF Anesthesiology
GMC Haldwani
Nainital
UTTARANCHAL
263139
India |
| Phone |
7456962335 |
| Fax |
|
| Email |
fatimaafseen83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A.K Sinha |
| Designation |
professor |
| Affiliation |
GMC Haldwani |
| Address |
2nd Floor, Department of Anesthesiology
GMC Haldwani
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897672301 |
| Fax |
|
| Email |
sinhaak1961@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A.K Sinha |
| Designation |
professor |
| Affiliation |
GMC Haldwani |
| Address |
2nd Floor,Department of Anesthesiology
GMC Haldwani
Nainital
UTTARANCHAL
263139
India |
| Phone |
09897672301 |
| Fax |
|
| Email |
sinhaak1961@gmail.com |
|
|
Source of Monetary or Material Support
|
| Afseen Fatima
2nd Floor Department of Anesthesiology
GMC Haldwani
Haldwani
Nainital
263139
India |
|
|
Primary Sponsor
|
| Name |
Afseen Fatima |
| Address |
2nd Floor Department Of Anesthesiology
GMC Haldwani
Nainital
263139
India
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Anesthesiology |
Department Of Anesthesiology 2nd floor STH Haldwani |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| afseen fatima |
GMC Haldwani |
2nd floor Elective OT
Shushila Tiwari Hospital
Haldwani
263139
Nainital
Nainital
UTTARANCHAL |
7456962335
fatimaafseen83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intrathecal Morphine and Dexmedetomidine |
to compare the efficacy of intrathecal Morphine 100ug versus Dexmedetomidine 5ug when used with Bupivacaine 2.5 ml(0.5% H) |
| Intervention |
Sub Arachnoid Block |
for infraumbilical surgery Sub Arachnoid Block using Bupivacaine (0.5%) with additives for post operative pain management |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient giving consent
patient under ASA I and ASA II |
|
| ExclusionCriteria |
| Details |
1.Patients with pre-existing respiratory, cardiac, diabetes mellitus, neurological disorders, hepatic or renal disease
2. Patient having local infection at the site of Subarachnoid block (SAB)
3. Patient on anticoagulant therapy
4. Patient with raised Intracranial pressure (ICP)
5. Patients with spinal abnormalities
6. Those with contraindications for spinal anesthesia
7. Patient with known case of bradycardia, hypotension and drug allergy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the effects of intrathecal hyperbaric bupivacaine 0.5% with morphine versus dexmedetomidine by determining the duration of analgesia in infraumbilical surgeries |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any adverse effects |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
15/03/2025 |
| 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 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
|
All patients posted for infraumbilical surgery will receive spinal anesthesia with 2.5 mg of hyperbaric bupivacaine (0.5%) added with either 100 micrograms of morphine or 5 micrograms of dexmedetomidine and compare the efficacy of both drugs to control post operative pain which would improve the outcome and early mobility and discharge. |