Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Supraclavicular Block

NCT04551833 | Unknown Phase 4 DMC

• 1 other identifier: supraclavicular block
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative analgesia in hours

  Duration of postoperative analgesia in hours

  24 hours

Secondary Outcomes (3)

• The anesthesia onset time

  20 minutes

• Dose of Paracetamol as rescue analgesia in mg

  24 hours

• Presence of complications and side effects

  24 hours

Study Arms (2)

Group (T) : 30 patients (Tramadol group)

EXPERIMENTAL

Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 1.5 mg/kg Tramadol.

Drug: Levobupivacaine

Group (D) : 30 patients (Dexamethasone group):

EXPERIMENTAL

Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 8mg of Dexamethasone

Drug: Levobupivacaine

Interventions

Levobupivacaine DRUG

Tramadol versus Dexamethasone as adjuvant to Levobupvacain

Group (D) : 30 patients (Dexamethasone group):; Group (T) : 30 patients (Tramadol group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologist physical status I-II patients older than 18years and scheduled for internal fixation for forearm fractures
• Both sexes

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 28740419 BACKGROUND

• 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.

  PMID: 29121400 BACKGROUND

• 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.

  PMID: 25948899 BACKGROUND

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Esraa Gamal Abdel Nasser, Resident

CONTACT

+201069721653; esraagamalabdelnasser@gmail.com

Mohamed Hassan Bakri, Professor

CONTACT

+201066356375; mhbakri@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, ICU and Pain management

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: September 16, 2020
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share