A Comparison of 4% Articaine Versus 0.5%Bupivacaine for Ambulatory Surgery Under Supraclavicular Block

NCT04189198 | Completed Phase 1 FDA Drug

• 1 other identifier: Articaine versus bupivacain
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of 2%Articaine versus 5%bupivacaine in pt undergoing short duration surgery in upper limb

Conditions

Upper Limb Surgery; Hand Surgery

Keywords

Articaine; Bupivacaine; Ultrasound; Supraclavicular block

Outcome Measures

Primary Outcomes (3)

• Duration of sensory block

  By pinprick test from 0 to 2 where 0 no sensory block and 2 complete anesthesia

  Measured in minutes over 24 hours

• Durations of motor block

  By Bromage scale from 1 to 4 where 1 no motor power and 4 full motor power

  Measured in minutes over 24 hours

• Duration of analgesia

  Measured by numerical analog scale where 0 no pain and 10 means worst pain

  Measured in minutes over 24 hours

Secondary Outcomes (1)

• Analgesia

  24 hours

Study Arms (2)

Articaine group

EXPERIMENTAL

Patients in this group are assigned to recieve 30 ml of Articaine 2%

Drug: Articaine

Bupivacaine

EXPERIMENTAL

Patients in this group are assigned to recieve 30 ml of bupivacaine 0.5%

Drug: Bupivacaine

Interventions

Articaine DRUG

Supraclavicular block with 30 ml articaine 2%

Also known as: Artinebsa

Articaine group

Bupivacaine DRUG

Supraclavicular block with 30 ml bupivacaine 0.5%

Also known as: Marcaine

Bupivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• upper limb surgery
• ganglion removal
• k wiring
• Carapal tunnel

You may not qualify if:

• Coagulopathy.
• infection at site of injection.
• patient refusal.
• hypersensitivity.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hosptal

Cairo, Abbasya, Egypt

Location

Related Publications (1)

• Armanious SH, Abdelhameed GA. A Randomized Controlled Trial: Comparison of 4% Articaine versus 0.5% Bupivacaine for Ambulatory Orthopedic Surgery under Supraclavicular Block. Anesthesiol Res Pract. 2020 Sep 24;2020:2194873. doi: 10.1155/2020/2194873. eCollection 2020.

  PMID: 33029135 DERIVED

MeSH Terms

Interventions

Carticaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Galal Mo El kadi, Doctor

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 6, 2019
• Study Start: December 30, 2019
• Primary Completion: March 22, 2020
• Study Completion: March 27, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 6 month after end of study
• Access Criteria: Upon request from Corresponding Author

Locations

EG (1)