TIVA with Propofol for Wounds

Phase-Based Estimates
3
Effectiveness
3
Safety
Carilion Clinic Institute of Orthopedics and Neurosurgery, Roanoke, VA
Wounds+7 More
TIVA with Propofol - Drug
Eligibility
18+
All Sexes
Eligible conditions
Wounds

Study Summary

This study is evaluating whether regional anesthesia is better than general anesthesia for patients undergoing surgery.

See full description

Eligible Conditions

  • Wounds
  • Wounds and Injuries
  • Rotator Cuff Tears
  • Musculoskeletal Diseases
  • Athletic Injuries
  • Orthopedic Disorders
  • Rotator Cuff Injuries
  • Sports Injuries
  • Anaesthesia therapy

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether TIVA with Propofol will improve 1 primary outcome and 6 secondary outcomes in patients with Wounds. Measurement will happen over the course of Immediately after the intervention/procedure/surgery.

Day 21
Pain Scale
During the intervention/procedure/surgery
Number of procedures requiring anesthetic intervention during surgery
Surgical time
Immediately after the intervention/procedure/surgery
Antiemetic use in PACU
Time to meet discharge criteria
post-anaesthesia care unit (PACU) I to post-anaesthesia care unit (PACU) II transition time
Day 21
Satisfaction scale

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Inhaled Anesthesia
TIVA-Propofol

This trial requires 192 total participants across 2 different treatment groups

This trial involves 2 different treatments. TIVA With Propofol is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

TIVA-Propofol
Drug
Intravenous anesthesia with Propofol
Inhaled Anesthesia
Drug
General Inhaled Anesthesia

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately after the intervention/procedure/surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly immediately after the intervention/procedure/surgery for reporting.

Closest Location

Carilion Clinic Institute of Orthopedics and Neurosurgery - Roanoke, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
This phrase refers to any person who is aged 18-75 years. show original
A person who is being considered for a shoulder arthroscopic procedure may be positioned in a beach chair show original

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 wounds?

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Wounds are injuries of many types that penetrate the skin by sharp objects, blunt objects, and burns. The wounds generally form in the area where the body is exposed to a source of sharp or sharp-edged pressure trauma. Wounds can be painful and they may be irritating to clothing or body surfaces, causing sweating or flushing of the skin in an attempt to protect the wound from damage. Wounds may be open to contamination with bacteria, and they may be infected, which results in sepsis and sometimes death. The main cause of bacterial infection after injury is the entry of bacteria into an open wound in the skin.

Unverified Answer

What are the signs of wounds?

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The signs and symptoms of wounds might be helpful in determining whether patients have wounds to be considered when assessing, treating and planning care. The signs might include bleeding and pain while sitting, as well as erythema.

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What are common treatments for wounds?

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The number of medications prescribed is lower than recommended by Canadian and American wound care guidelines, and wound medications are often not based on evidence. It is important to be aware of the common treatments for wounds prior to surgery.

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What causes wounds?

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Wounds cause an immunological response and thus a [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) state. The wound itself causes local inflammation, infection and the formation of a callus scar. The wound is associated with pain and physical changes, and this has a big influence on the quality of life of the person.

Unverified Answer

Can wounds be cured?

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Although wounds have many different presentations over the course of a year, there is always a high chance that they will heal over time. Therefore, there is no theoretical justification for believing that wounds will permanently leave a patient with scars.

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How many people get wounds a year in the United States?

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The World Health Organization estimate of 9.5 million acute wounds per year are based on studies conducted in South Asia. The number of individuals with chronic (unhealed) wounds has not been reported. It seems unlikely the actual burden of wounds in the United States is significantly lower than currently estimated.

Unverified Answer

What are the common side effects of tiva with propofol?

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We found that at any given dose of tiva with propofol, the occurrence and severity of the side effects of the combination were similar to those observed with propofol alone. While tiva with propofol tended to have greater onset and severity of effects, the overall incidence was not significantly different from propofol alone. These properties of tiva with propofol made this combination relatively safe and well-suited as a second agent during general anesthesia.

Unverified Answer

What is the average age someone gets wounds?

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Approximately 75% get their first traumatic wounds between the ages of 12 and 17. The average number of lifetime traumatic wounds is 15- 17 but varies based on age, sex, race, and other factors.

Unverified Answer

Is tiva with propofol safe for people?

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The authors could not find evidence that topical application of propofol under Tiva gel would result in toxic levels in patient serum after treatment. They found no adverse reactions in their patient sample. More intensive pharmacologically controlled studies on the use of propofol in Tiva are needed.

Unverified Answer

Have there been other clinical trials involving tiva with propofol?

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No clinical trials involving propofol for pain control and other indications involving tiva have been cited in the literature. There have been a number of publications about a number of cases of pain and other indications involving propofol in conjunction with tiva. Most of these cases have been from the same author and a number of these have been published in the same issue of the same journal. However, the authors of most of these studies did not specifically state that no clinical trials involving propofol are available for certain indications. In most cases, it is not obvious where the evidence for or against the therapeutic usage of propofol might fall.

Unverified Answer

Have there been any new discoveries for treating wounds?

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There has not, so current treatments are working well. We cannot say there have been any new avenues for treatment since new discoveries have not happened. There have been many other discoveries that we need to be able to afford, such as new discoveries relating to gene therapies, gene therapies for diseases of aging, stem cell treatments, therapies with anti-inflammatories, or even anticancer drugs. There has not been any significant research showing a cure for chronic wound healing. There has not been much research or new discoveries with regard to diabetic foot wound. There are a bunch of treatments out there, but we need to find a way to make sure that we can afford them.\n\nTo date, no cure has been found for chronic wound healing.

Unverified Answer

Does tiva with propofol improve quality of life for those with wounds?

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tiva in combination with propofol is effective in providing sedation for wounds. It also appears to improve pain-related quality of life. There were no adverse events associated with tiva, and pain scores were good even when compared with patients receiving standard analgesia with paracetamol alone. Further studies are necessary to confirm these findings and elucidate the mechanisms underlying the observed improvements in symptoms and quality of life when using tiva.

Unverified Answer
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