| CTRI Number |
CTRI/2024/09/073576 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Does adding Magnesium Sulphate prolongs the Pain Relief after Leg Surgeries? |
|
Scientific Title of Study
|
The Effects of Magnesium Sulphate as an Adjuvant to 0.5% Hyperbaric Levobupivacaine and Fentanyl in Patients Undergoing Lower Extremity Orthopedic Surgeries:A Randomized 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 |
Mayank Pal Singh |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8859168125 |
| Fax |
|
| Email |
mayank.jr2024@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Pranita Mandal |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8800768428 |
| Fax |
|
| Email |
parinita08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pranita Mandal |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8800768428 |
| Fax |
|
| Email |
parinita08@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHOPAL, MADHYA PRADESH, INDIA, 462020 |
|
|
Primary Sponsor
|
| Name |
Dr Pranita Mandal |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, Bhopal, Madhya Pradesh, India, 462020 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mayank Pal Singh |
AIIMS Bhopal |
Modular Operation Theatre, Department Of Anesthesiology, AIIMS Bhopal
Bhopal
MADHYA PRADESH |
8859168125
mayank.jr2024@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee - Student Research (IHEC-SR) |
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 |
| Intervention |
Magnesium Sulphate as an Adjuvant to 0.5% Hyperbaric Levobupivacaine and Fentanyl in Patients Undergoing Lower Extremity Orthopedic Surgeries |
A subarachnoid block is performed by an experienced anesthesiologist using a midline approach with local infiltration at the L3-4 or L4-5 intervertebral space. A 25 G Quincke’s spinal needle is used to administer the anesthetic drug: 2.5 ml (12.5 mg) of 0.5% hyperbaric levobupivacaine plus 0.4 ml of fentanyl (20 mcg), and 0.1 ml (50 mg) of preservative free magnesium sulphate (Group M), making a total volume of 3.0 ml. Afterwards, patients will be placed supine, and the primary investigator will record the vital signs and effect of the spinal drug i.e. motor and sensory levels at specified intervals using pinprick tests and the Modified Bromage Scale. If the block is insufficient after 20 min, general anesthesia will be administered. Post-surgery, patients are transferred to the post-anesthesia care unit for further monitoring and assessment. |
| Comparator Agent |
Normal Saline 0.9% as an Adjuvant to 0.5% Hyperbaric
Levobupivacaine and Fentanyl in Patients Undergoing Lower Extremity Orthopedic Surgeries |
A subarachnoid block is performed by an experienced anesthesiologist using a midline approach with local infiltration at the L3-4 or L4-5 intervertebral space. A 25 G Quincke’s spinal needle is used to administer the anesthetic drug: 2.5 ml (12.5 mg) of 0.5% hyperbaric levobupivacaine plus 0.4 ml of fentanyl (20 mcg), and 0.1 ml 0.9% of Normal saline (Group S), making a total volume of 3.0 ml. Afterwards, patients will be placed supine, and the primary investigator will record the vital signs and effect of the spinal drug i.e. motor and sensory levels at specified intervals using pinprick tests and the Modified Bromage Scale. If the block is insufficient after 20 min, general anesthesia will be administered. Post-surgery, patients are transferred to the post-anesthesia care unit for further monitoring and assessment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
18-65 years of age of either sex, ASA I or II, scheduled for orthopedic lower limb surgeries for like Total knee replacement, Arthroscopy, Open reduction internal fixation for
lower limb fractures etc., duration of surgery ≤ 4hours. |
|
| ExclusionCriteria |
| Details |
Patient refusal, local site infection, pregnancy, mental illness, chronic liver and renal diseases, deranged coagulation profile, history of scorpion bite |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the duration of postoperative analgesia (defined as the time to first request for
rescue analgesia) between the group receiving 50 mg intrathecal magnesium sulfate with a
combination of 0.5% hyperbaric levobupivacaine and fentanyl and the control group receiving
only the combination of 0.5% hyperbaric levobupivacaine and fentanyl.
2. To evaluate the time to achieve adequate sensory and motor block (onset time) following spinal
anesthesia in both the magnesium sulfate and the control group. |
After subarachnoid block
Baseline
2 min
4 min
6 min
8 min
10 min
12 min
14 min
16 min
18 min
20 min
35 min
50 min
65 min
80 min
95 min
110 min
125 min
185 min
245 min
Post Operative Monitoring
Baseline
30min
1 hr
2 hr
4 hr
8 hr
12 hr
18 hr
24 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess postoperative rescue analgesic requirements in both groups.
2. To compare hemodynamic stability between the groups throughout the perioperative period.
3. To assess the incidence of side effects like hypotension, pruritis, shivering, nausea and vomiting. |
After subarachnoid block
Baseline
2 min
4 min
6 min
8 min
10 min
12 min
14 min
16 min
18 min
20 min
35 min
50 min
65 min
80 min
95 min
110 min
125 min
185 min
245 min
Post Operative Monitoring
Baseline
30min
1 hr
2 hr
4 hr
8 hr
12 hr
18 hr
24 hr |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
16/09/2024 |
| 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="1"
Months="6"
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
|
Before surgery, patients undergo a routine pre-anesthetic checkup, including an explanation of the visual analog scale for pain and the spinal anesthetic procedure, followed by obtaining written informed consent. On the day of surgery, patients are moved to the operation table where ASA standard monitoring (5-lead ECG, non-invasive blood pressure, and pulse oximeter) is applied, and an 18 G intravenous cannula is secured. Lactated Ringer’s solution is administered at 15 ml/kg body weight. A subarachnoid block is then performed by an experienced anesthesiologist using a midline approach with local infiltration at the L3-4 or L4-5 intervertebral space. A 25 G Quincke’s spinal needle is used to administer the anesthetic solution: 2.5 ml of 0.5% hyperbaric levobupivacaine, 0.4 ml of fentanyl, and either 0.1 ml of magnesium sulphate (Group M) or 0.1 ml of normal saline (Group S). Post-injection, patients are placed supine, and the primary investigator, who is blinded to the group allocation, monitors vital signs at specified intervals. Intraoperative management includes treating hypotension and bradycardia with appropriate medications and providing supplemental oxygen if needed. Sensory and motor blocks are assessed regularly using pinprick tests and the Modified Bromage Scale. If the block is insufficient, general anesthesia is administered. Post-surgery, patients are transferred to the post-anesthesia care unit for further monitoring and assessment. |