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Bupivacaine for Pain
Study Summary
This trial will compare epidural and IV pain relief after spine surgery to see which is more effective.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have problems with your brain or nerves that affect how your body works.You have experienced damage to the protective layer around the brain during surgery.You are allergic to certain types of numbing medicines like lidocaine, bupivacaine, ropivacaine, or the pain medication fentanyl when used for epidural pain relief.You have difficulties thinking or remembering things that may affect your ability to accurately report your pain levels.Your immune system is weakened or not functioning properly.
- Group 1: Intravenous patient-controlled analgesia
- Group 2: Patient-Controlled Epidural Analgesia
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the eligibility for this research limited to those under twenty years old?
"According to the requirements for inclusion in this clinical trial, the lower and upper age limits are 18 and 80 respectively."
What potential side effects may arise from Bupivacaine usage?
"The safety rating of bupivacaine was evaluated to be a 3 due to the completion of Phase 4 trials, which is indicative of this medication's full approval."
For what maladies is Bupivacaine typically prescribed?
"The common medical treatment for pemphigus is Bupivacaine, which may also assist in managing acute nonspecific tenosynovitis, lupus erythematosus cell, and general anesthesia."
Who would be the ideal participants for this experiment?
"For this clinical trial, 58 adults aged 18-80 with pain are eligible to participate. In addition, participants must be scheduled for a 1-3 level elective posterior lumbar spinal fusion surgery."
What other research initiatives have included Bupivacaine as a primary subject?
"Currently, 150 trials are underway for bupivacaine. Of these active studies, 28 have reached the third and final phase of clinical research. These experiments are primarily based in Germantown, Tennessee; however there are 221 separate locations conducting investigations into this medication's efficacy."
What is the current intake capacity for this research project?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, which was initially advertised on May 8th 2017, is currently recruiting patients. In total 58 subjects are required to be recruited across two medical centres."
Are there any still available positions for people to join this clinical experiment?
"This experiment, initially posted on May 8th 2017 is still recruiting participants. As per the latest update, which was made on July 26th 2022, it is seeking individuals to take part in this trial."
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