| CTRI Number |
CTRI/2021/01/030252 [Registered on: 05/01/2021] Trial Registered Prospectively |
| Last Modified On: |
05/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Two drugs will be compared along with local anaesthetics in spinal anaesthesia. |
|
Scientific Title of Study
|
A comparative study of Intrathecal Fentanyl and Nalbuphine as an adjuvant to hyperbaric Bupivacaine for spinal anaesthesia in lower limb orthopaedic surgeries:A prospective double blinded randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhaprada satapathy |
| Designation |
post graduate trainee |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES,BBSR |
| Address |
Kalinga Institute of Medical Sciences,Dept Of ANAESTHESIOLOGY,3RD FLOOR,Campus 5,KIIT UNIVERSITY,Dist:KHORDHA
BBSR,PIN-751024.
Khordha
ORISSA
PIN-751024
India |
| Phone |
8093627227 |
| Fax |
|
| Email |
subhaprada1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh chandra Satapathy |
| Designation |
PROF & HOD,Dept of ANAESTHESIOLOGY,KIMS,BBSR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES,BBSR |
| Address |
Dept of ANAESTHESIOLOGY,Kalinga institute of medical sciences & PBMH,3rd floor, campus 5, BBSR.
Khordha
ORISSA
PIN-751024
India |
| Phone |
8283872939 |
| Fax |
|
| Email |
ganesh.satapathy@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh chandra Satapathy |
| Designation |
PROF & HOD,Dept of ANAESTHESIOLOGY,KIMS,BBSR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES,BBSR |
| Address |
Dept of ANAESTHESIOLOGY,Kalinga institute of medical sciences & PBMH,3rd floor,campus5,BBSR.
Khordha
ORISSA
PIN-751024
India |
| Phone |
8283872939 |
| Fax |
|
| Email |
ganesh.satapathy@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| KALINGA INSTITUTE OF MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
Subhaprada satapathy |
| Address |
Kalinga institute of medical sciences,Dept of ANAESTHESIOLOGY,3rd floor,Campus 5,BBSR.
Dist:Khordha,751024 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Subhaprada Satapathy |
Kalinga Institute of Medical Sciences |
KALINGA INSTITUTE OF MEDICAL SCIENCES,DEPT OF ANAESTHESIOLOGY,3RD FLOOR, Campus 5, Patia
BBSR-751024
ORISSA
Khordha
ORISSA |
8093627227
subhaprada1995@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: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Subarachnoid block |
Adjuvants along with hyperbaric bupivacaine will be given intrathecally in lower limb orthopaedic surgeries for post op pain managaement in patients. In Group BF(Bupivacaine fentanyl) will receive 25 microgram(0.5ml) of Fentanyl with 15mg(3ml) of 0.5% hyperbaric bupivacaine.
Group BN(Bupivacaine Nalbuphine) will receive 1mg(0.5ml) of nalbuphine with 15mg(3ml) of 0.5% hyperbaric bupivacaine. Visual analogue score will be assessed for 12hours. |
| Comparator Agent |
subarachnoid block |
Two different opioids will be compared when added as adjuvant to hyperbaric bupivacaine for post operative pain management in lower limb orthopaedic surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults in the age group of 18-65 years
2.ASA I or II
3.Elective lower limb surgeries
|
|
| ExclusionCriteria |
| Details |
1.Body mass index ≥30.
2.Height less than 155 cm.
3.Contraindications to spinal anaesthesia(patient refusal,coagulation disorder, infection at puncture site,increased intracranial tension, haemodynamic instability, spinal deformities,known history of allergy to the study drugs).
4.Patients on hypnotics,antipsychotics,tranquilizers or other CNS depressants.
5.Patients with history of adverse reaction to opioids.
6.Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of effective analgesia between the two drugs(time from intrathecal injection till the requirement of first rescue analgesic) |
1.5years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intraoperative haemodynamic parameters.
2.Post operative VAS
3.Incidence of side effects like sedation, pruritus, nausea, vomiting.
|
1.5years |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
12/01/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post operative pain control is a major concern because spinal anaesthesia using only local anaesthetics is associated with relatively shorter duration of action and thus early analgesic intervention is needed in post-operative period. There are very few studies which have compared efficacy of intrathecal Fentanyl and Nalbuphine as adjuvants to hyperbaric Bupivacaine in lower limb surgeries,therefore this present study is planned with the aim of comparing the analgesic effect & duration of analgesia provided by intathecal Fentanyl and Nalbuphine. |