Dexamethasone Dose in Low Volume Bupivacaine USG Supraclavicular Block

Phase 4

• Conditions: Dexamethasone; Supraclavicular Brachial Plexus Block
• Interventions: Procedure: Ultrasound guided supraclavicular brachial plexus block; Drug: Dexamethasone

• Registration Number: NCT03043495
• Lead Sponsor: Eslam Ayman Mohamed Shawki

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)

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 Timeline

• Study Start: 2016-10-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-03
• Last Update Submitted: 2017-02-03
• Study First Posted: 2017-02-06
• Last Update Posted: 2017-02-06
• Primary Completion: 2018-04-01
• Study Completion: 2018-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Ultrasound guided supraclavicular brachial plexus block	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.
Group Control	Ultrasound guided supraclavicular brachial plexus block	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.
Group B	Dexamethasone	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.
Group A	Ultrasound guided supraclavicular brachial plexus block	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.
Group C	Ultrasound guided supraclavicular brachial plexus block	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.
Group A	Dexamethasone	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.
Group C	Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	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

Name	Time	Method
Duration of motor block	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
Patient Satisfaction score	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
Incidence of PONV	24 hours	Incidence of postoperative nausea and vomiting
Incidence of complications	24 hours	Incidence of Pneumothorax, Nerve injury, Haematoma formation, Intravascular injection
Random Blood glucose levels	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

Trial Locations

Locations (1)

Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy); 🇪🇬 Cairo, Egypt