| CTRI Number |
CTRI/2023/11/060137 [Registered on: 22/11/2023] Trial Registered Prospectively |
| Last Modified On: |
21/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of reduction of pain by adding drugs like dexmedetomindine and nalbuphine to bupivacaine heavy in lower limb spinal surgeries |
|
Scientific Title of Study
|
A comparative study of analgesic effect of intrathecal nalbuphine hydrochloride with 0.5% hyperbaric bupivacaine and dexmedetomidine with 0.5% hyperbaric bupivacaine in lower limb 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 NISHI JAIN |
| Designation |
PG Resident |
| Affiliation |
PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
First floor, department of anaesthesia, peoples hospital, bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8962241810 |
| Fax |
|
| Email |
nishijain822@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Aditya Agarwal |
| Designation |
Professor |
| Affiliation |
Peoples college of medical sciences and research centre |
| Address |
First floor, department of anaesthesia, peoples hospital, bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8962241810 |
| Fax |
|
| Email |
ph.anaesthsia@peoplesuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR Nishi Jain |
| Designation |
PG Resident |
| Affiliation |
PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
First floor, Department of anaesthesia, peoples hospital, bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8962241810 |
| Fax |
|
| Email |
nishijain822@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples college of medical sciences and research centre Bhopal |
|
|
Primary Sponsor
|
| Name |
Peoples college of medical sciences bhopal |
| Address |
Pcms campus bhopal |
| 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 Nishi jain |
Peoples hospital |
Room no 1 First floor
Department of anaesthesia
peoples college of medical sciences and research centre
Peoples campus
bhopal
Bhopal
MADHYA PRADESH |
8962241810
nishijain822@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomindine |
Analgesic effect of dexmedetomindine with 0.5% bupivacaine intrathecally |
| Intervention |
Nalbuphine |
Analgesic effect of nalbuphine when added to 0.5% bupivacaine intrathecally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anesthesiologists (ASA) Grade I AND II patients
Patients undergoing elective lower limb surgeries
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analgesia |
180 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Motor blockade |
180 minutes |
|
|
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 4 |
|
Date of First Enrollment (India)
|
29/11/2023 |
| 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 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
|
We will be comparing the analgesic effect of nalbuphine hydrochloride with 0.5 % bupivacaine intrathecally and dexmedetomindine with 0.5% bupivacaine intrathecally in lower limb surgeries. |