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Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Supraclavicular Block

Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Under Ultrasound Guided Supraclavicular Block of Forearm Fractures

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04551833
Enrollment
60
Registered
2020-09-16
Start date
2021-04-01
Completion date
2023-05-01
Last updated
2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Regional Anesthesia

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 .

Interventions

DRUGLevobupivacaine

Tramadol versus Dexamethasone as adjuvant to Levobupvacain

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of postoperative analgesia in hours24 hoursDuration of postoperative analgesia in hours

Secondary

MeasureTime frameDescription
The anesthesia onset time20 minutesAnasthesia onset
Dose of Paracetamol as rescue analgesia in mg24 hoursRescue Analgesia in mg
Presence of complications and side effects24 hourscomplications and side effects

Contacts

Primary ContactEsraa Gamal Abdel Nasser, Resident
esraagamalabdelnasser@gmail.com+201069721653
Backup ContactMohamed Hassan Bakri, Professor
mhbakri@gmail.com+201066356375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026