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Clinical Trials/CTRI/2022/11/047461
CTRI/2022/11/047461Not yet recruitingNot Applicable

Comparison of two doses of dexmedetomidine as adjuvent to 0.5% Ropivacaine in ultrasound guided brachial plexus block in upper limb surgeries-A Randomised Control Trail

Rohilkhand Medical College and Hospital1 site in 1 country60 target enrollmentStarted: November 24, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Onset of motor block and duration of motor block

Study Overview

Brief Summary

In today’s world brachial plexus block has evolved as an important part of dailyroutine anaesthesiology practice as an substitute to general anaesthesia for upper limb surgeries. This mode of anaesthesia is also considered safe due to its application with an ultrasound guided live imaging. Also, it aids patient in form of providing post operative analgesia and reducing hospital stay that helps patient financially also.

The first supraclavicular block was performed in 1912 by kulen kampff byconventional parasthesia technique blind technique. Giving regional anaesthesia by blind technique has an high failure risk and risk of damaging vital anatomical structures. Ultrasound guided regional anaesthesia eliminates this drawback of blind technique.2 In 1978 La Grange introduced application of doppler probe to identify arteries .

In regional anaesthesia we use a local anaesthesia that is used to block the brachialplexus. These local anaesthetics have limited duration of action and providing post operativeanalgesia. Ropivacaine being a long acting amino amide is one of foremost drug used inbrachial plexus block. Ropivacaine when compared with bupivacaine and levobupivacainehas lower lipid solubility and hence provide greater sensory and motor blockade duration and also motor function recovery is fast.

Ropivacaine when compared with other local anaesthetic like bupivacaine and levobupivacaine is less cardiac and central nervous system toxic drug. It acts on voltage gatedsodium channels that blocks peripheral afferents.

Even with use of Ropivacaine it was found that duration of analgesia was limited andpatients complained of post operative pain and opiod administration was required to prolongpost operative analgesia duration. So use of adjuvents with  local anaesthetic came into existence such as dexmedetomidine, clonidine, opioids and neostigmine. These helped toprolong post operative analgesia. Opioids are known to cause various side effects like apnea,respiratory suppression, hypoxia so dexmedetomidine provides anaesthesiologists with abetter alternative to opoids and helps to elinminates these side effets.

Dexmedetomidine is an alpha 2 receptor blocker agonist that can be used as anadjuvent to local anaesthetic in order to prolong duration of post operative analgesia and to decrease time of onset . Dexmedetomidine has analgesic, sedative antihypertensive and anaesthetic sparing properties that contributes multimodaly. Dexmedetomidine as alpha 2agonist is highly selective (more than 8 times selective as compared to clonidine ) as an adjuvant.

Previous studies are present that have compared various local anaesthetics alone andwith combination with adjuvents in brachial plexus blocks for upper limb surgeriesindividually. To our comprehension few study are known to have compared effects ofropivacaine in regional anaesthesia in brachial plexus block in combination with two differentdosages of dexmedetomidine, and access results of these two groups.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

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

Inclusion Criteria

  • American society of Anesthesiologist (ASA) grade I or II Posted for surgery of upper limb under ultrasound guided brachial plexus block.

Exclusion Criteria

  • Refusal by patient Patients taking anticoagulants, β- blockers or opioids, psychotropic medication.
  • Patients with history of significant​neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease.
  • Patients having history of drug and alcohol abuse.
  • Patients with contraindication to Ropivacaine and dexmedetomidine.
  • Women with pregnancy or lactating women.
  • Patients on chronic analgesic therapy, diabetes or having coagulation disorders.
  • Patient with infection at site of injection.

Outcomes

Primary Outcomes

Onset of motor block and duration of motor block

Time Frame: The patient will be evaluated for sensory and motor block for every 2 minutes for first 20 minutes every 3 minutes for next 30 minutes, every 10 minutes for 60 minutes and finally every 15 minutes until the sensory and motor block regresses

Onset of sensory block and duration of sensory block

Time Frame: The patient will be evaluated for sensory and motor block for every 2 minutes for first 20 minutes every 3 minutes for next 30 minutes, every 10 minutes for 60 minutes and finally every 15 minutes until the sensory and motor block regresses

Duration of postoperative analgesia

Time Frame: The patient will be evaluated for sensory and motor block for every 2 minutes for first 20 minutes every 3 minutes for next 30 minutes, every 10 minutes for 60 minutes and finally every 15 minutes until the sensory and motor block regresses

Secondary Outcomes

  • Hemodynamic responses to the drug during and after surgery.

Investigators

Sponsor
Rohilkhand Medical College and Hospital
Sponsor Class
Private medical college

Study Sites (1)

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