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.

Study Overview

• Status: Not yet recruiting
• Conditions: Regional Anesthesia
• Intervention / Treatment: Drug: Levobupivacaine

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Esraa Gamal Abdel Nasser, Resident; Phone Number: +201069721653; Email: esraagamalabdelnasser@gmail.com
• Study Contact Backup: Name: Mohamed Hassan Bakri, Professor; Phone Number: +201066356375; Email: mhbakri@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group (T) : 30 patients (Tramadol group); Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 1.5 mg/kg Tramadol.	Drug: Levobupivacaine; Tramadol versus Dexamethasone as adjuvant to Levobupvacain
Experimental: Group (D) : 30 patients (Dexamethasone group): Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 8mg of Dexamethasone	Drug: Levobupivacaine; Tramadol versus Dexamethasone as adjuvant to Levobupvacain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of postoperative analgesia in hours	Duration of postoperative analgesia in hours	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The anesthesia onset time	Anasthesia onset	20 minutes
Dose of Paracetamol as rescue analgesia in mg	Rescue Analgesia in mg	24 hours
Presence of complications and side effects	complications and side effects	24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: supraclavicular block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No