Comparison Of Dexmedetomidine And Dexamethasone As An Adjuvant To Bupivacaine In Brachial Plexus Block

NCT04791475 | Completed DMC

• 1 other identifier: TribhuvanUTH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Brachial plexus block is a regional anaesthesia technique employed as a safe and valuable alternative to general anaesthesia for upper limb surgery. In recent practices of day care surgeries, brachial plexus block seems to be a better alternative to general anesthesia with minimal hospital stay and better analgesic effect. Among several techniques of brachial plexus block, supraclavicular approach is considered as easiest, effective and can be performed much more quickly than other approaches. Various local anaesthetic agents and adjuvants are used for this purpose. Among them, bupivacaine has been the most widely used long-acting local anaesthetic agent. Combining local anesthetics with different adjuncts can prolong the duration of analgesia associated with brachial plexus block. Among various adjuncts, dexamethasone and dexmedetomidine have been identified as clinically effective adjuncts. Several metaanalyses have convincingly demonstrated their efficacy in prolonging the analgesic duration of brachial plexus block. However, there has been limited research conducted to compare the effects of dexamethasone and dexmedetomidine added as adjuvants to the local anesthetics for BPB. Studies have demonstrated benefits of one agent over other without any definitive conclusion as which is the best agent for this purpose. Therefore, there is a need of study to compare the onset and duration of bupivacaine when dexmedetomidine or dexamethasone is used as an adjuvant to bupivacaine for ultrasound-guided supraclavicular BPB

Conditions

Brachial Plexus Block; Dexmedetomidine; Dexamethasone; Bupivacaine

Keywords

Brachial Plexus Block; Dexmedetomidine; Dexamethasone; Bupivacaine

Outcome Measures

Primary Outcomes (1)

• duration of analgesia

  The time between drug administration and request for first analgesic medication or NRS (numerical rating scale) score more than or equal to 4 will be recorded as duration of analgesia

  20 hours

Secondary Outcomes (3)

• onset and duration of sensory blockade

  20 hrs

• onset and duration of motor blockade

  20 hrs

• To assess for adverse events

  20 hrs

Study Arms (2)

Dexmedetomidine with 0.5% bupivacaine

EXPERIMENTAL

1mcg/kg dexmedetomidine as an adjuvant to 0.5% bupivacaine 20 ml in USG guided Supraclavicular Brachial Plexus Block

Procedure: adding Dexmedetomidine and dexamethasone to bupivacaine in USG guided supraclavicular brachial plexus block.

Dexamethasone with 0.5% bupivacaine

ACTIVE COMPARATOR

4mg dexamethasone as an adjuvant to 0.5% bupivacaine 20 ml in USG guided Supraclavicular Brachial Plexus Block

Procedure: adding Dexmedetomidine and dexamethasone to bupivacaine in USG guided supraclavicular brachial plexus block.

Interventions

adding Dexmedetomidine and dexamethasone to bupivacaine in USG guided supraclavicular brachial plexus block. PROCEDURE

The linear transducer probe (frequency 4 -12 Hz) of USG machine will be used. A superficial skin wheal will be made by 2ml of 1% lignocaine subcutaneously at the point of needle insertion. USG guided Brachial plexus block will be performed by supraclavicular route via the subclavian perivascular approach in in-plane technique from lateral to medial using 22 gauge spinal needle. Study Drug will be administered via Pressure Monitoring line connected to syringe according to the allocated group with repeated aspiration and incremental dosing. • Intercostobrachial nerve block will be performed to alleviate the tourniquet pain. A 25 G needle will be inserted at the level of axillary fossa. The entire width of the medial aspect of arm, starting at the deltoid prominence and proceeding inferiorly, will be infiltrated with 5ml of 1% Lignocaine with Epinephrine (1:4,00,000) to raise a subcutaneous wheal. •

Dexamethasone with 0.5% bupivacaine; Dexmedetomidine with 0.5% bupivacaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA PS I \& II
• Age: 18-65 years
• Sex: Both male and female
• Patients scheduled for Upper limb surgery below the level of midshaft of humerus

You may not qualify if:

• Local infection at the site of puncture
• Patients having any neurologic deficit in the upper limb
• Pregnant or lactating women.
• Patients receiving adrenoceptor agonist or antagonist therapy or chronic analgesic therapy.
• Patients with diabetic neuropathy, peripheral vascular disease, coagulopathy, or known allergies.
• Patients with polytrauma.
• Patients weighing \<30 kg and \> 100 kg.

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

Study Sites (1)

Tribhuvan University Teaching Hospital

Kathmandu, Bagmati, 44600, Nepal

Location

Related Publications (1)

• Vorobeichik L, Brull R, Abdallah FW. Evidence basis for using perineural dexmedetomidine to enhance the quality of brachial plexus nerve blocks: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2017 Feb;118(2):167-181. doi: 10.1093/bja/aew411.

  PMID: 28100520 BACKGROUND

Study Officials

• Manu Bhattarai

  MD resident

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Manu Bhattarai, Resident

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 10, 2021
• Study Start: February 22, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 30, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)