| CTRI Number |
CTRI/2024/11/076851 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of fentanyl and magnesium added to levobupivacaine heavy for spinal anaesthesia in lower limb surgeries |
|
Scientific Title of Study
|
Comparison of the effect of intrathecal fentanyl citrate and magnesium sulphate as adjuvants to hyperbaric levobupivacaine 0.5 per cent for spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries A prospective randomised study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anusha Tripathy |
| Designation |
PG resident, Dept of Anaesthesiology |
| Affiliation |
Gajra Raja Medical College |
| Address |
GRMC and JA Hospital, Lashkar, Gwalior
Gwalior
MADHYA PRADESH
474001
India |
| Phone |
9861631036 |
| Fax |
|
| Email |
dr.anushatripathy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neelima Tandon |
| Designation |
Professor and Head, Super Speciality Hospital, Dept of Anaesthesiology |
| Affiliation |
Gajra Raja Medical College |
| Address |
GRMC and JA Hospital, Lashkar, Gwalior
Gwalior
MADHYA PRADESH
474001
India |
| Phone |
9826215586 |
| Fax |
|
| Email |
dr.neelimatandon21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anusha Tripathy |
| Designation |
PG resident, Dept of Anaesthesiology |
| Affiliation |
Gajra Raja Medical College |
| Address |
GRMC and JA Hospital, Lashkar, Gwalior
MADHYA PRADESH
474001
India |
| Phone |
9861631036 |
| Fax |
|
| Email |
dr.anushatripathy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesiology, GR Medical College and JA Hospital, Gwalior |
|
|
Primary Sponsor
|
| Name |
Gajra Raja Medical College and Jay Arogya Group of Hospitals |
| Address |
Gajra Raja Medical College, Lashkar, Gwalior 474009 |
| Type of Sponsor |
Government 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 Anusha Tripathy |
Gajra Raja Medical College |
Department of Anesthesiology, G R Medical College and Jaya Arogya Hospital, Gwalior 474009
Gwalior
MADHYA PRADESH |
09861631036
dr.anushatripathy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gajra Raja Medical College, Gwalior |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, (2) ICD-10 Condition: S723||Fracture of shaft of femur, (3) ICD-10 Condition: S724||Fracture of lower end of femur, (4) ICD-10 Condition: S721||Pertrochanteric fracture, (5) ICD-10 Condition: S870||Crushing injury of knee, (6) ICD-10 Condition: S878||Crushing injury of lower leg, (7) ICD-10 Condition: S820||Fracture of patella, (8) ICD-10 Condition: S821||Fracture of upper end of tibia, (9) ICD-10 Condition: S822||Fracture of shaft of tibia, (10) ICD-10 Condition: S823||Fracture of lower end of tibia, (11) ICD-10 Condition: S824||Fracture of shaft of fibula, (12) ICD-10 Condition: S828||Other fractures of lower leg, (13) ICD-10 Condition: S920||Fracture of calcaneus, (14) ICD-10 Condition: S978||Crushing injury of foot, (15) ICD-10 Condition: M871||Osteonecrosis due to drugs, (16) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
levobupivacaine |
levobupivacaine heavy 0.5 % 3 ml + normal saline |
| Comparator Agent |
Levobupivacaine + Fentanyl |
Levobupivacaine heavy 0.5 % 3 ml + Fentanyl 25 mcg |
| Comparator Agent |
levobupivacaine + magnesium |
Levobupivacaine heavy 0.5% 3 ml + magnesium sulphate 50 mg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients consenting to participate in the study, aged between 18-60 years, of both sexes, of ASA grade I or II, admitted to undergo lower limb orthopaedic procedures in our institute were included in this study |
|
| ExclusionCriteria |
| Details |
Patients declining consent, aged less than 18 or greater than 60 years, ASA grades III or IV, suffering from any respiratory, cardiac, hepatic, renal, neurological or coagulation disorder, pregnant or already receiving opioid or magnesium therapy or having any local infection at the site of injection of spinal anaesthesia were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| onset and duration of sensory and motor block, duration of analgesia |
onset of sensory and motor blockade at baseline
duration of sensory blockade when the spinal block regresses till S1 (in minutes)
duration of motor block till time of first mobilisation (in minutes)
duration of analgesia until the patient requests rescue analgesia at VAS score greater than 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| haemodynamic parameters |
baseline, intraoperative intervals predefined at 5, 10, 15, 30, 45, 60, 90, 120 & 150 minutes |
| side effects |
in the postoperative period |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/11/2024 |
| 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
|
: This prospective randomised study to compare the effects of fentanyl vs magnesium sulphate as adjuvants to 0.5% hyperbaric levobupivacaine in orthopaedic surgeries under subarachnoid block shall include ninety ASA grade I and II patients aged 18-60 yrs undergoing orthopaedic surgeries. Group LS: 3ml 0.5% levobupivacaine heavy + 0.5ml normal saline. Group LF: 3ml 0.5% levobupivacaine heavy + fentanyl 25µg. Group LM: 3ml 0.5% levobupivacaine heavy + magnesium sulphate 50mg + 0.4ml normal saline. The onset and duration of sensory and motor block and intraoperative haemodynamics will be recorded. In the postoperative period, duration of analgesia, time to first request of analgesia, VAS scores, and side effects will be observed and compared amonf all three groups. |