Clinical trial NCT04551833: Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Supraclavicular Block
Official title: Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Under Ultrasound Guided Supraclavicular Block of Forearm Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Regional Anesthesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 .

Eligibility criteria: 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

Primary outcomes:
measure: Duration of postoperative analgesia in hours
timeFrame: 24 hours
Secondary outcomes:
measure: The anesthesia onset time
timeFrame: 20 minutes
measure: Dose of Paracetamol as rescue analgesia in mg
timeFrame: 24 hours
measure: Presence of complications and side effects
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Zhao WL, Ou XF, Liu J, Zhang WS. Perineural versus intravenous dexamethasone as an adjuvant in regional anesthesia: a systematic review and meta-analysis. J Pain Res. 2017 Jul 4;10:1529-1543. doi: 10.2147/JPR.S138212. eCollection 2017.
citation: Pehora C, Pearson AM, Kaushal A, Crawford MW, Johnston B. Dexamethasone as an adjuvant to peripheral nerve block. Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011770. doi: 10.1002/14651858.CD011770.pub2.
citation: Nagpal V, Rana S, Singh J, Chaudhary SK. Comparative study of systemically and perineurally administered tramadol as an adjunct for supraclavicular brachial plexus block. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):191-5. doi: 10.4103/0970-9185.155147.