Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Supraclavicular Block

Regional Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04551833
• Other study ID #: supraclavicular block
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: Esraa Gamal Abdel Nasser, Resident
• Phone: +201069721653
• Email: esraagamalabdelnasser[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Regional Anesthesia

Intervention

Drug:
• Levobupivacaine
Tramadol versus Dexamethasone as adjuvant to Levobupvacain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View 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:CD011770. doi: 10.1002/14651858.CD011770.pub2. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of postoperative analgesia in hours	Duration of postoperative analgesia in hours	24 hours
Secondary	The anesthesia onset time	Anasthesia onset	20 minutes
Secondary	Dose of Paracetamol as rescue analgesia in mg	Rescue Analgesia in mg	24 hours
Secondary	Presence of complications and side effects	complications and side effects	24 hours