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Clinical Trials/CTRI/2024/03/063571
CTRI/2024/03/063571
Not yet recruiting
Phase 4

ULTRASOUND GUIDED AXILLARY APPROACH TO BRACHIAL PLEXUS FOR HAND SURGRIES COMPARISION OF MAGNESIUM SULPHATE AND DEXMEDETOMIDINE AS ADJUVANTS TO ROPIVACAINE

Dr Sunil Chiruvella1 site in 1 country60 target enrollmentStarted: March 11, 2024Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Dr Sunil Chiruvella
Enrollment
60
Locations
1
Primary Endpoint
Primary objective is to compare onset and

Overview

Brief Summary

Axillary brachial plexus blocks are frequently used during hand and forearm procedures. Ropivacaine’s effectiveness is increased when Dexmedetomidine and magnesium sulphate are used for peripheral nerve blocks because they increase the duration of analgesia. This study was aimed to evaluate the effects of. Ropivacaine with magnesium sulphate and Ropivacaine with Dexmedetomidine in the axillary block.Site-specific, efficient, and long-lasting anaesthetic is provided via regional anaesthesia. To enable painless surgery, plexus block is employed as the primary anaesthetic approach. It is also utilised to alleviate chronic pain and post-operative discomfort.Regional anaesthesia is administered during procedures on the upper limbs using a brachial plexus block. Interscalene, supraclavicular, infraclavicular, and axillary are some other techniques. The axillary method to the brachial plexus block is well-liked for its simplicity, dependability, and safety. It is recommended for forearm and hand surgery.With a safer cardiac profile than bupivacaine, ropivacaine is a brand-new long-acting amide local anaesthetic (LA) used for peripheral nerve blocks. It offers both a sensory and a motor blockage. Adjuvant supplementation increases the effectiveness of LA by accelerating the start of action, extending the duration of activity, and providing postoperative analgesia.When administered systemically, magnesium sulphate (MgSO4) has analgesic, antihypertensive, and anaesthetic sparing effects. MgSO4 is now often utilised as an adjuvant to plane blocks, other peripheral nerve blocks, and neuroaxial blocks. However, research on MgSO4’s use as an adjuvant in the axillary block is quite limited.As an adjuvant to LAs, dexmedetomidine is a selective alpha 2 adrenoreceptor agonist. It is believed to shorten the onset and increase the duration of activity, and prolong postoperative analgesia.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients undergoing hand surgeries ASA 1 & 2.

Exclusion Criteria

  • Patients with Co-existing severe cardiovascular respiratory or neurological disorders Patients with any known history of coagulation disorders and inflammatory and infective skin lesions at the site of block Pre-existing neuropathies and allergy to local anaesthetics.

Outcomes

Primary Outcomes

Primary objective is to compare onset and

Time Frame: 5 mins | 10 mins | 15 mins | 30 mins | 1 hour | 2 hours | 6 hours | 12 hours

duration of sensory and motor blockade

Time Frame: 5 mins | 10 mins | 15 mins | 30 mins | 1 hour | 2 hours | 6 hours | 12 hours

Secondary Outcomes

  • Secondary objective is to compare hemodynamic changes, Time for requirement of rescue analgesia and adverse effects in both groups(5 mins)

Investigators

Sponsor
Dr Sunil Chiruvella
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Nagella Jagadeesh Babu

Government Medical College Kadapa

Study Sites (1)

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