Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Supraclavicular Block

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Regional Anesthesia

Treatments: Drug: Levobupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04551833

supraclavicular block

Details and patient eligibility

About

The investigator's aim will be to compare the efficacy of perineural tramadol and dexamethasone added to levobupivacaine in prolonging postoperative analgesia in patient undergoing open reduction and internal fixation for forearm fractures.

Primary outcome: duration of postoperative analgesia. Secondary outcome: include [The anesthesia onset time, total rescue analgesic consumption in the 1st 24-hour and the presence of complications and side effects.

Full description

Strategies to prolong brachial plexus nerve blocks analgesia beyond the pharmacological duration of the local anaesthetic used include placement of indwelling perineural catheters to allow prolonged infusion or the co-administration of adjuvants such as epinephrine, alpha 2 agonists (as clonidine and dexmedetomidine), midazolam, or the corticosteroid dexamethasone .

Dexamethasone improves the quality and duration of peripheral nerve block over local anaesthetic alone. This is thought to be mediated by attenuating the release of inflammatory mediators, reducing ectopic neuronal discharge, and inhibiting potassium channel-mediated discharge of nociceptive C-fibres .

Tramadol is a unique opioid with two modes of action for inhibition of pain, an opioid action mediated by the μ receptor and a non-opioid action mediated by α-2-adrenergic and serotoninergic activity .The monoaminergic activity of tramadol inhibits the descending pain pathways, resulting in suppression of nociceptive transmission at the spinal level . Tramadol also exhibits local anaesthetic properties by blocking K+ channels .Many studies have characterized the effects of tramadol as an adjuvant to local anaesthetic in brachial plexus block .

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologist physical status I-II patients older than 18years and scheduled for internal fixation for forearm fractures
• Both sexes

Exclusion criteria

• Patients with known allergy to the study drugs
• Skin infection at site of needle puncture
• Significant organ dysfunction
• Coagulopathy
• Drug or alcohol abuse
• Epilepsy and psychiatric illness that would interfere with perception and assessment of pain

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Group (T) : 30 patients (Tramadol group)

Experimental group

Description:

Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 1.5 mg/kg Tramadol.

Treatment:

Drug: Levobupivacaine

Group (D) : 30 patients (Dexamethasone group):

Experimental group

Description:

Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 8mg of Dexamethasone

Treatment:

Drug: Levobupivacaine