A Phase 4 interventional study of Levobupivacaine in Regional Anesthesia, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
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.
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 .
Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 1.5 mg/kg Tramadol.
Drug: Levobupivacaine
Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 8mg of Dexamethasone
Drug: Levobupivacaine
Tramadol versus Dexamethasone as adjuvant to Levobupvacain
Duration of postoperative analgesia in hours
Duration of postoperative analgesia in hours
Time frame: 24 hours
The anesthesia onset time
Anasthesia onset
Time frame: 20 minutes
Dose of Paracetamol as rescue analgesia in mg
Rescue Analgesia in mg
Time frame: 24 hours
Presence of complications and side effects
complications and side effects
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assiut University