Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Supraclavicular Block
Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Under Ultrasound Guided Supraclavicular Block of Forearm Fractures
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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 .
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Esraa Gamal Abdel Nasser, Resident
- Telefonnummer: +201069721653
- E-mail: esraagamalabdelnasser@gmail.com
Undersøgelse Kontakt Backup
- Navn: Mohamed Hassan Bakri, Professor
- Telefonnummer: +201066356375
- E-mail: mhbakri@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Group (T) : 30 patients (Tramadol group)
Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 1.5 mg/kg Tramadol.
|
Tramadol versus Dexamethasone as adjuvant to Levobupvacain
|
|
Eksperimentel: Group (D) : 30 patients (Dexamethasone group):
Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 8mg of Dexamethasone
|
Tramadol versus Dexamethasone as adjuvant to Levobupvacain
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Duration of postoperative analgesia in hours
Tidsramme: 24 hours
|
Duration of postoperative analgesia in hours
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The anesthesia onset time
Tidsramme: 20 minutes
|
Anasthesia onset
|
20 minutes
|
|
Dose of Paracetamol as rescue analgesia in mg
Tidsramme: 24 hours
|
Rescue Analgesia in mg
|
24 hours
|
|
Presence of complications and side effects
Tidsramme: 24 hours
|
complications and side effects
|
24 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- supraclavicular block
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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