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CTRI Number  CTRI/2023/11/060211 [Registered on: 23/11/2023] Trial Registered Prospectively
Last Modified On: 21/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effect of intraveous versus perineural magnesium sulphate as adjuvant in supraclavicular block  
Scientific Title of Study   Comparative evaluation between perineural magnesium sulphate and intravenous magnesium sulphate as an adjuvant to Ropivacaine in USG guided supraclavicular brachial plexus block. 
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 Lini Rajan  
Designation  Junior Resident 
Affiliation  Rajarajeswari medical college and hospital 
Address  Rajarajeswari medical college and hospital, Department of Anaesthesiology, Kambipura, Mysore Road, Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  9562127168  
Fax    
Email  linililliz@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sudheer R 
Designation  Professor 
Affiliation  Rajarajeswari medical college and hospital 
Address  Rajarajeswari medical college and hospital, Department of Anaesthesiology, Kambipura, Mysore Road, Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  9741117754  
Fax    
Email  sudheerramegowda81@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Lini Rajan  
Designation  Junior Resident 
Affiliation  Rajarajeswari medical college and hospital 
Address  Rajarajeswari medical college and hospital, Department of Anaesthesiology, Kambipura, Mysore Road, Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  9562127168  
Fax    
Email  linililliz@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari medical college and hospital, Department of anaesthesiology , Kambipura, 
 
Primary Sponsor  
Name  Rajarajeswari medical college and hospital 
Address  Rajarajeswari medical college and hospital, Department of anaesthesiology , Kambipura, Mysore Road, Karnataka ,560074 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lini Rajan  Rajarajeswari medical college and hospital  Rajarajeswari medical college and hospital, Department of Anaesthesiology, Kambipura, Mysore Road, Karnataka
Bangalore
KARNATAKA 
919562127168

linililliz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajarajeswari Medical College and Hospital – Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M844||Pathological fracture, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection Ropivacaine 0.75% 20 ml +150 mg of Magnesium sulphate in block  Intravenous line secured with 18G cannula in the unaffected limb and given I.V. fluids according to the requirement. 100ml of 0.9% normal saline intravenously 30 minutes before giving supraclavicular brachial plexus block.The patient will be placed in supine position with the head turned 45 degrees to the contralateral side. An ultrasound machine with a linear type of probe will be used. After skin preparation and local anesthetic infiltration of skin, the supraclavicular fossa scanned to locate the subclavian artery, first rib, pleura, and brachial plexus cluster, and then a 22-gauge, 5 cm, echogenic needle advanced from the lateral to medial in the long axis of the ultrasound beam. The needle advanced towards the ‘corner pocket’, where the lower trunk commonly lies in this area (between the subclavian artery medially, the first rib inferiorly and the plexus superiorly), and then half volume of prepared Injection Ropivacaine 0.75% 20 ml +150 mg of Magnesium sulphate was injected, then reposition the needle cranially toward the neural cluster in order to apply the remaining volume of local anesthetic just above and lateral to subclavian artery.Total duration of the procedure is 1 hour  
Comparator Agent  Injection Ropivacaine 0.75% 20 ml +2mL of normal saline   Intravenous line secured with 18G cannula in the unaffected limb and given I.V. fluids according to the requirement. injection Magnesium sulphate 150mg in 100ml of 0.9% normal saline intravenously 30 minutes before giving supraclavicular brachial plexus block . The patient will be placed in supine position with the head turned 45 degrees to the contralateral side. An ultrasound machine with a linear type of probe will be used. After skin preparation and local anesthetic infiltration of skin, the supraclavicular fossa scanned to locate the subclavian artery, first rib, pleura, and brachial plexus cluster, and then a 22-gauge, 5 cm, echogenic needle advanced from the lateral to medial in the long axis of the ultrasound beam. The needle advanced towards the ‘corner pocket’, where the lower trunk commonly lies in this area (between the subclavian artery medially, the first rib inferiorly and the plexus superiorly), and then half volume of prepared Injection Ropivacaine 0.75% 20 ml +2mL of normal saline was injected, then reposition the needle cranially toward the neural cluster in order to apply the remaining volume of local anesthetic just above and lateral to subclavian artery.Total duration of the procedure 1 hour 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Both sexes, aged between 18-60 years belonging to ASA I and II those who are posted for elective upper limb surgeries (Surgeries of distal humerus, elbow, forearm and hand) 
 
ExclusionCriteria 
Details  1. Patient refusal,
2. Pregnant and lactating mothers,
3. ASA III and IV,
4. Known Allergy/contraindication to local anesthetic,
5. Patients having peripheral neuropathy and preexisting neurological defects in upper limbs,
6. Known cases of seizure disorder,
7. Patients with coagulopathies and patients on chronic anticoagulation therapy,
8.Patients with psychiatric illness and local skin infections.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the duration of analgesia by intravenous versus perineural MgSO4.  VAS score in first 24 hours post surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the onset and duration of sensory and motor blockade.
To study analgesic consumption in 24 hours and any side effects.
 
Intraoperative and postoperative period 24 hrs post surgery 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   01/12/2023 
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="0"
Months="8"
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  

PNB is the practical alternative to general anesthesia for surgery as it provides quality analgesia. 

• In patients with profound co-morbidities such as severe respiratory disorders, cardiovascular diseases, morbid obesity and those with difficult airways where GA posses technical difficulty, PNB is a better alternative.In present anaesthesia practice to prolong postoperative analgesia use of various adjuvants is routinely done .

•Ropivacaine is an aminoamide local anesthetic that blocks the peripheral afferents acting on voltage dependent sodium channels.

•Magnesium is necessary for the presynaptic release of acetylcholine from nerve endings and may produce effects like calcium‑entry‑blocking drugs. Magnesium has long been used for its analgesic, antihypertensive, and anesthetic sparing effects. 

•Magnesium sulphate is one of the widely used adjuvant used in different routes along with regional anaesthesia to prolong postoperative analgesia. 

•Our current study was designed to compare  perineural magnesium sulphate and intravenous magnesium sulphate when used as an adjuvant with ropivacaine in supraclavicular block under USG guidance for upper limb surgeries. 

•Method of data collection: A prospective randomized single blinded open study will be planned. In patients whom the block failed to act will be left out of the study.

 On the day before surgery the patients will be attended and examined properly. A detailed medical and surgical history taken along with pre anaesthetic evaluation. Patients will be explained regarding the procedure and taught to interpret the visual analogue scale (VAS) (graded from 0 = no pain to 10 = maximum pain).  On arrival of the patient in the operation theatre, all standard ASA monitors connected .Intravenous line secured with 18G cannula in the unaffected limb and given I.V. fluids according to the requirement. The intravenous study drug, provided in the seal envelope, was started via a separate 20G intravenous cannula 30 minutes before brachial plexus block.

The patient will be placed in supine position with the head turned 45 degrees to the contralateral side. An ultrasound machine with a linear type of probe will be used. After skin preparation and local anesthetic infiltration of skin, the supraclavicular fossa scanned to locate the subclavian artery, first rib, pleura, and brachial plexus cluster, and then a 22-gauge, 5 cm, echogenic needle advanced from the lateral to medial in the long axis of the ultrasound beam. The needle advanced towards the ‘corner pocket’, where the lower trunk commonly lies in this area (between the subclavian artery medially, the first rib inferiorly and the plexus superiorly), and then half volume of prepared local anesthetic mixture either with saline or with 150 mg Magnesium was injected, then reposition the needle cranially toward the neural cluster in order to apply the remaining volume of local anesthetic just above and lateral to subclavian artery. During the intraoperative period, heart rate, blood pressures will be noted every 5 minutes (min) during the first 15 min., and then every 15 min. throughout the surgery. Inadequate sensory and motor blockade beyond 30 min following the infiltration of local aesthetics will be considered as an unsuccessful block.

 
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