Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Supraclavicular Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-05-01

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Regional Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group (T) : 30 patients (Tramadol group)

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

Group Type EXPERIMENTAL

Levobupivacaine

Intervention Type DRUG

Tramadol versus Dexamethasone as adjuvant to Levobupvacain

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

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

Group Type EXPERIMENTAL

Levobupivacaine

Intervention Type DRUG

Tramadol versus Dexamethasone as adjuvant to Levobupvacain

Interventions

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Levobupivacaine

Tramadol versus Dexamethasone as adjuvant to Levobupvacain

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No