| CTRI Number |
CTRI/2025/01/079680 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study comparing magnesium sulphate(chemical) and dexamethasone(steroid) with levobupivacaine(local anesthetic) in infraclavicular(below neck)nerve block(anesthesia technique) for pain control in patients undergoing below elbow surgeries using ultrasound(non invasive imaging) |
|
Scientific Title of Study
|
Effectiveness of Ultrasound guided Infraclavicular block with 0.5%levobupivacaine with Magnesium Sulfate vs 0.5%levobupivacaine with Dexamethasone in below Elbow orthopedic surgeries-A Randomised Double Blinded 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 |
Gnana Mounica Nadimpalli |
| Designation |
Post graduate student |
| Affiliation |
IMS and SUM hospital |
| Address |
Department of Anesthesiology,
IMS and SUM hospital,
Siksha O Anusandhan University, khordha, Bhubaneswar
Khordha ORISSA 751003 India |
| Phone |
9494575619 |
| Fax |
|
| Email |
gnanamounica08@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madhusmita Patro |
| Designation |
Associate Professor |
| Affiliation |
IMS and SUM hospital |
| Address |
Department of Anesthesiology IMS and SUM hospital
Siksha O Anusandhan University Bhubaneswar
Khordha 751003
Orissa
India
Khordha ORISSA 751003 India |
| Phone |
07746063128 |
| Fax |
|
| Email |
dr.madhu.patro@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Madhusmita Patro |
| Designation |
Associate Professor |
| Affiliation |
IMS and SUM hospital |
| Address |
Department of Anesthesiology IMS and SUM hospital
Siksha O Anusandhan University Bhubaneswar
Khordha 751003
Orissa
India
ORISSA 751003 India |
| Phone |
07746063128 |
| Fax |
|
| Email |
dr.madhu.patro@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS and SUM hospital, Siksha O Anusandhan University, Bhubaneswar,Khordha,751003 |
|
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Primary Sponsor
|
| Name |
Institute of Medical Science and Sum Hospital |
| Address |
K8 Kalinga Nagar
Bhubaneswar
Orissa 751003 |
| 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 Gnana Mounica Nadimpalli |
Institute of Medical Science, Siksha O Anusandhan |
Department of Anesthesiology IMS and SUM hospital
Siksha O Anusandhan University Bhubaneswar
Khordha 751003
Orissa
India Khordha ORISSA |
09494575619
gnanamounica08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IMS and SUM Hospital, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone |
Patients will be receiving 2ml (8mg) Dexamethasone with 20ml 0.5%levobupivacaine(total-22ml)for the infraclavicular block and we measure the duration analgesia and VAS score measured at 0,1,2,4,6,8,12,18,24hrs and to compare the onset of sensory and motor block |
| Intervention |
Magnesium Sulfate |
Patients will be receiving 2ml(200mg)10% Magnesium Sulfate with 20ml 0.5%levobupivacaine( total-22ml) for the infraclavicular block and we measure the duration of analgesia and VAS score measured at 0,1,2,4,6,8,12,18,24hrs and to compare onset of sensory and motor block |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective below Elbow orthopedic surgeries
2.Patient within the age group of 20 years to 60years
3.Patients under ASA I and II |
|
| ExclusionCriteria |
| Details |
1.Patients under ASA III and ASA IV
2.Duration of surgery greater than 2hrs
3.Patients with coagulation disorders
4.Patient known allergic to local anesthetic agents
5.Skin infection at local sites
6.Patient refusal to give consent for the study.
7.If the block is inadequate and patient is converted into general anesthesia
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of analgesia and (VISUAL ANALOG SCORE)VAS score and onset of sensory and motor block between Magnesium sulfate and Dexamethasone |
0,1,2,4,6,8,12,18,24HRS postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
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Target Sample Size
|
Total Sample Size="86" Sample Size from India="86"
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)
|
10/02/2025 |
| 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="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 randomized double blind comparative study will be conducted at our institution over a period of 2 years. In this study 86 ASA grade I and II patients between age 20 years to 60 years with BMI <= 30kg/m2 posted for elective below elbow orthopaedic surgery requiring Ultrasound guided Infraclavicular block will be included. After taking written informed consent from, patients will be randomized to 2 groups (n= 43 each ) by computer generated random number table. All patients will be thoroughly examined pre-operatively which includes blood pressure, heart rate, respiratory rate and systemic examination, and ASA grading. The patients with a contraindication to procedure like allergic reaction to local anesthetics or major neurological, cardiovascular, metabolic, respiratory, renal disease, or coagulation abnormalities will be excluded. After recording preoperative baseline Heart Rate and Blood Pressure intravenous access is established using 18G cannula. Standard intraoperative monitoring includes ECG, NIBP, HR, and SPO2. Ringers lactate is used for replacement and maintenance fluid as per standard guidelines of perioperative fluid administration. The drug combination will be prepared by one anesthesiologist or pharmacist and will be given by another anesthesiologist who is blinded to the drug used in the study. Both the patients and the observer will be blinded to the study drug or the group. Proper positioning for infraclavicular block with the patient supine and head turned to opposite side and arm abducted to 90 degree and the elbow fixed. Under all aseptic precautions Ultrasound guided Infraclavicular block is given in the below 2 groups In group M: The patients will be given 2ml of 10% Magnesium Sulfate with 20ml 0.5%levobupivacaine in total 22ml solution In group D: The patients will be given 2ml Dexamethasone with 20ml 0.5%levobupivacaine in total 22ml solution. Onset time for sensory and motor block will be noted. The Sensory Block (SB) was assessed using pin prick test. All dermatomes supplied by radial, ulnar, median and musculocutaneous nerves were assessed. The SB was graded 0 = Normal sensation, 1=Loss of sensation to pin prick,2=Loss of touch sensation. The Motor Block (MB) was graded according to modified bromage scale which is 0=No movement in fingers, wrist and elbow, 1=Finger movement, 2=Flexion of wrist against gravity, 3=Flexion of elbow against gravity. The onset time of SB is the time interval from injection of local anesthetic till the complete SB achieved. The duration of the SB is the time interval between onset of complete SB and complete resolution of SB. Duration of analgesia is the time between onset of complete SB and the first dose of post operative analgesia. The block is considered successful when sensory block is 2 and motor block is 0 within 30 min after local anesthetic is given, otherwise block is considered as failed or inadequate. Post operative analgesia is achieved by giving diclofenac 75mg iv every 12hrs. Pain assessment was done by using Visual Analogue Scale (VAS) which is expressed on 11-point numerical scale 0-10 and recorded in the postoperative care unit at 0, 1, 2, 4, 6, 8, 12, 18, and 24 hours postoperative. 0 = No pain (one extreme) 10 = Worst pain possible (other extreme) |