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Dexamethasone Dose in Low Volume Bupivacaine USG Supraclavicular Block

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ClinicalTrials.gov Identifier: NCT03043495
Recruitment Status : Unknown
Verified February 2017 by Eslam Ayman Mohamed Shawki, Cairo University.
Recruitment status was:  Recruiting
First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Eslam Ayman Mohamed Shawki, Cairo University

Study Description
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Brief Summary:
A dose-ranging study to test various doses of Dexamethasone (2, 4 & 8 mg) to be used as an adjuvant to Local anesthetic drugs in ultrasound guided low volume Supraclavicular brachial plexus block to find the best balance between valuable effects (mainly duration of analgesic Effect) and side-effects (mainly increased random blood sugar levels)

Condition or disease Intervention/treatment Phase
Dexamethasone Supraclavicular Brachial Plexus Block Procedure: Ultrasound guided supraclavicular brachial plexus block Drug: Dexamethasone Phase 4

Detailed Description:

Brachial plexus nerve blocks (BPBs) for upper extremity surgery provide superior analgesia and reduce opioid consumption. Supraclavicular block anesthetizes the brachial plexus where it is in its most compact form, thus providing a complete and reliable block for upper extremity surgery. Ultrasound guided single injection (SI) and triple injection (TI) techniques were found to provide the same degree of surgical anesthesia at 30 minutes while the TI technique needed more time to perform.

Many studies were conducted to examine the effect of perineural Dexamethasone as a local anesthetic adjuvant in low volume peripheral nerve blocks were it was found to increase the mean duration of analgesia (sensory block) with short, medium and long acting local anesthetics as well as the duration of motor blockade, with a reduction in pain scores at rest during the intermediate (8-12 h) and late (24 h) postoperative periods and in movement at all times. At 24 postoperative hours, cumulative morphine consumption and the rate of nausea or vomiting were also reduced without any reported related serious adverse effects, also the value of its concomitant intravenous use in prolonging the duration of analgesia after regional blocks was studied with promising results that can sometimes be compared to the perineural route but more short-lived and associated with higher increase in blood glucose levels. Dexamethasone's mechanism of action may result from decreased nociceptive C-fibre activity via a direct effect on glucocorticoid receptors and inhibitory effect on potassium channels.(8) Other authors suggest a local vasoconstrictive effect, resulting in reduced local anaesthetic absorption or a systemic anti-inflammatory effect following vascular uptake of the drug.

A debate exists whether perineural corticosteroids are harmful or not, but reports of neurotoxicity seem to be related mainly to the preservative benzyl alcohol and the vehicle polyethylene glycol found in some preparations, also may be related to the presence of insoluble steroid particulate matter in the injectate. Dexamethasone is non-particulate and can be found in a preservative-free formulation. In addition, no significant long-term electrophysiological, behavioural or histological effects for corticosteroids were identified on rat sciatic nerve tissue even some data suggest dexamethasone may actually be neuroprotective. In reality, perineural corticosteroid injections with and without preservative are widely used throughout the world.

Various doses of Dexamethasone were used in local anaesthetic mixtures in regional blocks in various studies, including 4, 5, 8 and 10 mg. In a recent review & meta-analysis by E. Albrecht and his colleagues, sub-group analysis revealed no association between the total dose of perineural Dexamethasone and the mean increase in duration of analgesia showing that Dose-finding studies are needed to better define the optimal balance between dose, effects and side-effects, particularly at doses lower than 4 mg.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The patients will be randomized to 4 groups:

  • Group A: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 0.5ml (2mg) Dexamethasone, 1.5ml Normal saline.
  • Group B: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 1ml (4mg) Dexamethasone, 1ml Normal saline.
  • Group C: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml (8mg) Dexamethasone.
  • Group Control: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml Normal saline.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The patient and the attending anesthetist who will manage the patient intra-operatively and perform the block, will be blinded to the patient group allocation All recorded values will be obtained by personnel blinded to the group allocation of the patient.
Primary Purpose: Treatment
Official Title: The Optimal Dose Of Dexamethasone To Be Used As An Adjuvant To Low Volume Bupivacaine Ultrasound Guided Supraclavicular Brachial Plexus Block. A Randomized Controlled Double Blinded Dose Ranging Study
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A
N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 0.5ml (2mg) Dexamethasone, 1.5ml Normal saline.
 Procedure: Ultrasound guided supraclavicular brachial plexus block
ultrasound guided Supraclavicular brachial plexus block

Drug: Dexamethasone
Various doses of Dexamethasone (2, 4 & 8 mg) to be used as an Adjuvant to Local anesthetic drugs
Other Name: Decadron
Active Comparator: Group B
N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 1ml (4mg) Dexamethasone, 1ml Normal saline.
 Procedure: Ultrasound guided supraclavicular brachial plexus block
ultrasound guided Supraclavicular brachial plexus block

Drug: Dexamethasone
Various doses of Dexamethasone (2, 4 & 8 mg) to be used as an Adjuvant to Local anesthetic drugs
Other Name: Decadron
Active Comparator: Group C
N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml (8mg) Dexamethasone.
 Procedure: Ultrasound guided supraclavicular brachial plexus block
ultrasound guided Supraclavicular brachial plexus block

Drug: Dexamethasone
Various doses of Dexamethasone (2, 4 & 8 mg) to be used as an Adjuvant to Local anesthetic drugs
Other Name: Decadron
Active Comparator: Group Control
N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml Normal saline.
 Procedure: Ultrasound guided supraclavicular brachial plexus block
ultrasound guided Supraclavicular brachial plexus block


Outcome Measures
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Primary Outcome Measures :
  1. Duration of analgesia [ Time Frame: 24 hours ]
    The time between injection of Local anesthetic mixture during performing the block and time of administration of the first dose of rescue analgesia at VAS equal or more than 4


Secondary Outcome Measures :
  1. Duration of motor block [ Time Frame: 24 hours ]
    The time between injection of Local anesthetic mixture during performing the block and regaining full motor power in the distribution of all 4 nerves represented by score 6 on Modified Lovett rating scale

  2. Patient Satisfaction score [ Time Frame: 24 hours ]
    A point on a 10 point numeric scale where 0 is very dissatisfied and 10 very satisfied one time at the end of the first postoperative 24 hours

  3. Random Blood glucose levels [ Time Frame: 24 hours ]
    Random blood glucose level readings will be obtained from the patient using fast strip test (ACCU-CHEK.) First, upon arrival to the operating theatre, then at the end of the operation then every 8 hours in the first 24 hours postoperatively

  4. Incidence of PONV [ Time Frame: 24 hours ]
    Incidence of postoperative nausea and vomiting

  5. Incidence of complications [ Time Frame: 24 hours ]
    Incidence of Pneumothorax, Nerve injury, Haematoma formation, Intravascular injection


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing surgeries in the upper limb (arm, forearm or hand)

Exclusion Criteria:

  • Coagulopathies (with prothrombin concentration less than 60% or INR more than 1.5)
  • In-ability to postpone anti-coagulation medications.
  • Infection or injury or a lesion at the block site.
  • Suspected cervical vertebral column injury necessitating using a neck collar.
  • A compromised lung on the contralateral side of the block (Pneumothorax, hemothorax or Pneumonectomy).
  • Traumatic vascular injuries or operative interventions (Surgical harvesting) involving arteries of the upper limb on the operative side.
  • Patients with communication difficulties.
  • Hypersensitivity to local anesthetics and/or Dexamethasone.
  • Patients on perioperative intravenous (IV) steroids.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043495


Contacts
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Contact: Eslam A Shawki, M.D. +201225771017 eslam.ayman@kasralainy.edu.eg

Locations
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Egypt
Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy) Recruiting
Cairo, Egypt
Contact: Eslam A Shawki, M.D    '+201225771017    eslam.ayman@kasralainy.edu.eg   
Sponsors and Collaborators
Eslam Ayman Mohamed Shawki
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Eslam Ayman Mohamed Shawki, Lecturer of anesthesia, SICU & Pain Management, Cairo University
ClinicalTrials.gov Identifier: NCT03043495    
Other Study ID Numbers: DexSupraClav
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eslam Ayman Mohamed Shawki, Cairo University:
dexamethasone
supraclavicular brachial plexus block
ultrasound
Additional relevant MeSH terms:
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Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents