Ambulatory surgery in the United States, 2006.
Karen A Cullen, Margaret J Hall, Aleksandr Golosinskiy
https://pubmed.ncbi.nlm.nih.gov/19294964/Actively Recruiting
Led by Paul Hoff · Updated on 2021-05-19
38
Participants Needed
2
Research Sites
N/A
Total Duration
Tonsillectomy is a common surgical procedure in adults, often performed for recurrent throat infections and obstructive issues. This trial evaluates the use of a long-acting local anesthetic called bupivacaine liposome injectable suspension Exparel to help manage pain after tonsillectomy. The study aims to see if adding Exparel to the standard pain control medication can reduce pain intensity and the need for other pain medicines during the critical first days after surgery. Participants are randomly assigned to receive either the standard care medication, bupivacaine HCl with epinephrine, or the standard care followed by the adjunct Exparel. Both treatments are given by injection into specific areas around the tonsil location immediately after tonsil removal and before waking from anesthesia. This approach is designed to directly target the surgical site to control pain. During the study, participants pain levels are monitored at several points after surgery, specifically on days 1, 2, 3, 5, and 10. Researchers also track how much prescribed narcotic and over-the-counter pain medication participants use during this time. The goal is to assess changes in pain and medication needs. The study involves a single treatment administration during surgery and follow-up observations over 10 days to evaluate outcomes and recovery.
CONDITIONS
EXPAREL Post-tonsillectomy Clinical Trial
P
Paul T Hoff, MD
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Paul Hoff
Lead Sponsor
St. Joseph Mercy Ann Arbor
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Adjunct Exparel (bupivacaine liposome suspension 1.3%) plus standard care | Standard care (bupivacaine HCl 0.25% with epinephrine) |
|---|---|---|
| What is it? | Combined treatment with Exparel (a long-acting bupivacaine liposome suspension 1.3%) infiltrated into the tonsillar pillars, following standard care infiltration with bupivacaine HCl 0.25% with epinephrine. | Standard care involving infiltration of bupivacaine HCl 0.25% with epinephrine into the tonsillar pillars after removal of the tonsils. |
| Role in the trial | Investigational therapy arm receiving both the study drug and standard regimen for comparison of pain after tonsillectomy. | Comparator arm receiving only standard care as currently practiced. |
| Primary use | Intended to reduce post-tonsillectomy pain and possibly decrease the need for narcotic pain medication after surgery. | Helps control pain after tonsillectomy as standard local anesthetic care. |
| How it is given | After removal of the tonsils and before extubation, both standard bupivacaine HCl with epinephrine, then Exparel, are injected into the upper and lower poles of the anterior and posterior tonsillar pillars on both sides. | Standard bupivacaine HCl with epinephrine is injected into the same areas (upper and lower poles, tonsillar pillars) after tonsil removal and before extubation. |
| Evidence status | Liposomal bupivacaine has limited direct trial evidence specifically in adults after tonsillectomy; other studies support its use for postoperative pain in various procedures. | Standard local anesthetic infiltration is widely supported by published evidence and guidelines for reducing post-tonsillectomy pain. |
| Important limitations | Clinical outcomes with Exparel in tonsillectomy remain incompletely established, and no efficacy results are yet posted for this trial. Use of Exparel increases overall drug exposure, and rare reactions to bupivacaine can occur. | Pain control with standard local anesthetics can vary, and some patients may still need additional pain medications. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single treatment during surgery
Participants receive an injection of standard care medication with or without the adjunct Exparel immediately after tonsil removal during surgery.
Duration - 10 days after surgery
Participants are monitored for pain levels and medication use on post-operative days 1, 2, 3, 5, and 10 to assess recovery.
5 follow-up assessments
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/18983373/Paul Hoff
Lead Sponsor
St. Joseph Mercy Ann Arbor
Collaborating Sponsor