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Brachial Plexus BlockPhase 3NCT02787018

Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block

A Phase 3 study testing Ropivacaine and Normal saline, Ropivacaine and Dexamethasone and Ropivacaine and Dexmedetomidine in people with Brachial Plexus Block, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Brachial Plexus Block
What is being tested?
Ropivacaine and Normal saline, Ropivacaine and Dexamethasone and Ropivacaine and Dexmedetomidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteNepal
Study dates
Jun 2016to Sep 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients of American Society of Anesthesiologists Physical Status I and II undergoing elective upper limb surgery under supraclavicular brachial plexus block

Who cannot join

  • Patient's refusal to participate
  • Patients weighing less than 40 kg
  • Allergy to study drugs
  • Infection at the site of injection
  • Patients with preexisting neurological deficit
  • Patients with diabetes mellitus
Show all 11Show fewer
  • Patients on steroids preoperatively
  • Patients with bleeding disorder or coagulopathy
  • Abnormalities in ECG like AV block or symptomatic bradycardia
  • Patients receiving adrenoreceptor agonist or antagonist therapy preoperatively
  • Requirement of conversion to general anesthesia due to inadequate block

Trial locations and contacts

1 site in 1 country.

Nepal1 site

  • B. P. Koirala Institute of Health Sciences

    Dharān, Koshi, 56700

Other trials in Nepal

About this study

The investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.

Read the detailed description

Ropivacaine is a newer local anesthetic which is structurally related to bupivacaine, but has fewer side effects. It is more cardio stable than bupivacaine, but the onset of action is delayed and the duration of action is shorter than bupivacaine making its use during regional anesthesia less preferable to many anesthesiologists. Steroids like dexamethasone, or alpha-2 agonists like dexmedetomidine are being studied as adjuvants to ropivacaine for brachial plexus block to improve its anesthetic properties and have shown favorable outcome in terms of shortening the onset of block and prolonging the duration of action. But no study has been done to compare their effects. So in this study the investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.

Being tested
Ropivacaine and Normal saline, Ropivacaine and Dexamethasone, Ropivacaine and Dexmedetomidine
Keywords
Brachial plexus block, Ropivacaine, Dexmedetomidine, Dexamethasone, Adjuvants, anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine and Normal salineDrug

    Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 1 ml normal saline

  • Ropivacaine and DexamethasoneDrug

    Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 4mg (1ml) dexamethasone

  • Ropivacaine and DexmedetomidineDrug

    Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 50 mcg (1ml) dexmedetomidine

Study groups in NCT02787018
Study groupRoleWhat they receive
Block with Ropivacaine and Normal salinePlacebo comparatorPatients will receive brachial plexus block with 20 ml 0.5% ropivacaine with 1ml normal saline: Total volume 21 ml
Receives: Drug: Ropivacaine and Normal saline
Block with Ropivacaine and DexamethasoneActive comparatorPatients will receive brachial plexus block with 20ml 0.5% ropivacaine with 4mg (1ml) dexamethasone: Total volume 21 ml
Receives: Drug: Ropivacaine and Dexamethasone
Block with Ropivacaine and DexmedetomidineExperimentalPatients will receive brachial plexus block with 20ml 0.5% ropivacaine with 50mcg (1ml) dexmedetomidine: Total volume 21 ml
Receives: Drug: Ropivacaine and Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Onset of sensory block

    Sensory block in the territories of median nerve (palmar surface of index finger), ulnar nerve (palmar surface of little finger), radial nerve (dorsal surface of first web space/ thumb) and musculocutaneous nerve (lateral side of volar surface of forearm) will be assessed by pinprick test using a 3-point scale:

    0 - normal sensation,

    1. - loss of sensation of pinprick (analgesia),
    2. - loss of sensation of touch (anaesthesia). Complete sensory block will be defined as grade 2 sensory block in 3 or more nerve territories.

    Measured: every 3 minutes until 45 minutes after injection of drug

  2. Onset of motor block

    Motor block will be evaluated by thumb flexion/ opposition (median nerve), thumb extension (radial nerve), finger abduction (ulnar nerve) and elbow flexion with forearm in full supination (musculocutaneous nerve) on a 3-point scale for motor function:

    0 - normal motor function,

    1. - reduced motor strength but able to move,
    2. - complete motor block. Complete motor block will be defined as grade 2 motor block in 3 or more nerve territories.

    Measured: every 3 minutes until 45 minutes after injection of drug

  3. Duration of analgesia

    Measured: Up to 24 hours after onset of block

Secondary outcomes (3)

  1. Duration of sensory block

    time from onset of sensory block to complete recovery of anaesthesia on all nerves.

    Measured: Up to 24 hours after onset of block

  2. Duration of motor block

    time from onset of motor block to the recovery of complete motor function of the hand and forearm

    Measured: Up to 24 hours after onset of block

  3. Incidence of side effects of drugs

    Side effects like bradycardia, tachycardia, hypotension, sedation, neurological deficit will be evaluated

    Measured: Forty-eight hours following the injection of local anesthetics

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionSep 2018
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02787018
Sponsor's protocol ID
IRC/641/015
Status last verified
Oct 2018
First submitted
14 May 2016
Last updated
10 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10.

    PubMed 24413428

  • Das A, Majumdar S, Halder S, Chattopadhyay S, Pal S, Kundu R, Mandal SK, Chattopadhyay S. Effect of dexmedetomidine as adjuvant in ropivacaine-induced supraclavicular brachial plexus block: A prospective, double-blinded and randomized controlled study. Saudi J Anaesth. 2014 Nov;8(Suppl 1):S72-7. doi: 10.4103/1658-354X.144082.

    PubMed 25538527

  • Kumar S, Palaria U, Sinha AK, Punera DC, Pandey V. Comparative evaluation of ropivacaine and ropivacaine with dexamethasone in supraclavicular brachial plexus block for postoperative analgesia. Anesth Essays Res. 2014 May-Aug;8(2):202-8. doi: 10.4103/0259-1162.134506.

    PubMed 25886227

  • Zhang Y, Wang CS, Shi JH, Sun B, Liu SJ, Li P, Li EY. Perineural administration of dexmedetomidine in combination with ropivacaine prolongs axillary brachial plexus block. Int J Clin Exp Med. 2014 Mar 15;7(3):680-5. eCollection 2014.

    PubMed 24753763

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ropivacaine and Normal saline, Ropivacaine and Dexamethasone and Ropivacaine and Dexmedetomidine in people with Brachial Plexus Block, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Onset of sensory block (time frame: every 3 minutes until 45 minutes after injection of drug). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02787018, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.

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