Syringe for Anaesthesia therapy

1
Effectiveness
1
Safety
Brigham and Women's Hospital, Boston, MA
Syringe - Device
Eligibility
18+
Female
Eligible conditions
Anaesthesia therapy

Study Summary

Superiority of Epidural Placement Technique Using EpiFaith Syringe

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Syringe will improve 1 primary outcome in patients with Anaesthesia therapy. Measurement will happen over the course of 30 minutes.

30 minutes
Success of epidural localization

Trial Safety

Side Effects for

Total Children (Aged: 1 to 15 Years)
Device related infection
57%
Viral upper respiratory tract infection
57%
Pyrexia
43%
Device breakage
43%
Rash
43%
Wound complication
29%
Haemorrhage subcutaneous
29%
Device damage
29%
Urticaria
29%
Dental caries
29%
Cough
29%
Dehydration
29%
Enteritis
29%
Stomatitis
29%
Constipation
29%
Influenza
29%
Dry skin
29%
Miliaria
29%
Vomiting
14%
Asthma
14%
Hand-foot-and-mouth disease
14%
Hypozincaemia
14%
Injection site pain
14%
Injury corneal
14%
Metabolic acidosis
14%
Fracture
14%
Gastrostomy tube site complication
14%
Nausea
14%
Acne
14%
Enterocolitis
14%
Medical device site infection
14%
Conjunctivitis
14%
Arthritis bacterial
14%
Viral pharyngitis
14%
Hypomagnesaemia
14%
Epididymitis
14%
Device occlusion
14%
Conjunctivitis allergic
14%
Rhinorrhoea
14%
Colonic haematoma
14%
Anaemia
14%
Adenoviral conjunctivitis
14%
Periodontitis
14%
Lip dry
14%
Head banging
14%
Heat stroke
14%
Seasonal allergy
14%
Dermatitis allergic
14%
Eye discharge
14%
Drug-induced liver injury
14%
Food allergy
14%
Lipase increased
14%
Cheilitis
14%
Joint swelling
14%
Myalgia
14%
Rectal prolapse
14%
Streptococcal infection
14%
Strabismus
14%
Infected bite
14%
Fall
14%
Neoplasm
14%
Gastric disorder
14%
Transaminases increased
14%
Amylase increased
14%
Ileus
14%
Abdominal pain
14%
Abdominal distension
14%
Epiphyseal injury
14%
Central venous catheter removal
14%
Skin induration
14%
Upper respiratory tract inflammation
14%
Beta haemolytic streptococcal infection
14%
Eczema
14%
Skin erosion
14%
Gastroenteritis
14%
Procedural pain
14%
Epistaxis
14%
Drug eruption
14%
Ligament injury
14%
Pancreatitis acute
0%
Blood alkaline phosphatase increased
0%
Seizure
0%
Dermatitis diaper
0%
Otitis media
0%
Aspartate aminotransferase increased
0%
Dermatitis
0%
Upper respiratory tract infection
0%
Rhinitis allergic
0%
Injection site reaction
0%
Alanine aminotransferase increased
0%
Gastroenteritis adenovirus
0%
Oral candidiasis
0%
Eosinophil count increased
0%
Viral infection
0%
Contusion
0%
Auricular haematoma
0%
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03268811) in the Total Children (Aged: 1 to 15 Years) ARM group. Side effects include: Device related infection with 57%, Viral upper respiratory tract infection with 57%, Pyrexia with 43%, Device breakage with 43%, Rash with 43%.

Trial Design

2 Treatment Groups

Conventional group
EpiFaith® group

This trial requires 680 total participants across 2 different treatment groups

This trial involves 2 different treatments. Syringe is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

EpiFaith® group
Device
Study subject will have the epidural placement with an EpiFaith® syringe.
Conventional group
Device
Study subject will have the epidural placement with a conventional glass syringe.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Syringe
2018
Completed Phase 3
~170

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 minutes
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 minutes for reporting.

Who is running the study

Principal Investigator
J. Z.
Prof. Jie Zhou, Assistant Professor
Harvard Medical School (HMS and HSDM)

Closest Location

Brigham and Women's Hospital - Boston, MA

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Females 18 years of age and older at screening
Request labor epidural analgesia
Able to give informed consent to participate in the study
American Society of Anesthesiologists (ASA) class Ⅰ to Ⅲ health status
BMI ≤ 40 kg/m2

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is anaesthesia therapy?

Add answer

Although the scope of this article has been limited, this article has identified the most important factors within the context of this type of surgical practice for anaesthesia. A multi-disciplinary team is necessary with specific responsibilities and responsibilities for all members of the team, with an emphasis on responsibility for patients. Anaesthesia practice should reflect a commitment to ongoing continuous improvement of care and a commitment to working collaboratively with all members of the patient team.

Unverified Answer

What are the signs of anaesthesia therapy?

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The main signs of anaesthesia treatment are nausea and vomiting. More than half of patients develop a rash at their skin site. Less than half of patients experience pain and itching. More than 90% of the patients experience a change in skin colour - either a temporary reddening of a skin site or a skin colour change that changes with the duration of anaesthesia treatment. Other signs include pain, fatigue and dizziness. The onset of nausea and/or vomiting varies in patients and may be unpredictable. Although nausea and vomiting are some of the most serious side effects of anaesthetics, most anaesthesia patients can expect these symptoms to resolve over time.

Unverified Answer

What are common treatments for anaesthesia therapy?

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The most common treatments for anaesthesia therapy are opioids such as pethidine and fentanyl. For general anaesthetics, local anaesthetic injections such as lidocaine, propofol and ropivacaine are often used. Intravenous sedation is also increasingly being used.

Unverified Answer

Can anaesthesia therapy be cured?

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[Physical therapy and exercise therapy, which can help to regain function, mobility and confidence can also help patients with rheumatoid arthritis improve their quality of life. (...) Anaesthesia therapy is generally prescribed as a part of a rehabilitation program, where all forms of active exercise including walking, are prescribed, with the goals to improve functioning and functional mobility for persons with rheumatoid arthritis. For instance, patients with rheumatoid arthritis may be prescribed joint mobilization exercises and joint mobilizers, who wear a manual instrument that is used to guide the joint. (...) For instance, patients with rheumatoid arthritis may be prescribed joint mobilization exercises and joint mobilisers, who wear a manual instrument that is used to guide the joint.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Anaesthesia therapy by sharing your contact details with the study coordinator.