| 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
|
|
|
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
|
|
|
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. |