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Constant A Busch, Benjamin J Shore, Rakesh Bhandari...
https://pubmed.ncbi.nlm.nih.gov/16651569/Actively Recruiting
Led by Lahey Clinic · Updated on 2025-11-06
70
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating the effectiveness of a long-acting local anesthetic cocktail compared to regional nerve block and standard care for pain control in patients undergoing surgery to fix ankle fractures. This multicenter, randomized control trial aims to improve pain management, reduce opioid use, and assess the economic impact of these pain control methods in adults with specific types of ankle fractures. The study includes three groups one receiving standard post-operative pain control with oral narcotics, another receiving a single injection of a perioperative peripheral nerve block plus oral narcotics as needed, and the third receiving a subcutaneous injection of the local anesthetic cocktail plus oral narcotics as needed. The cocktail includes ropivicaine, clonidine, epinephrine, and saline, with the total dose adjusted based on incision size. Treatments are administered during surgery, and patients are followed for pain control and costs. Participants will undergo surgery for bimalleolar ankle fractures and then receive one of the three pain management strategies. Researchers will monitor the amount of oral narcotics taken during the first 72 hours after surgery as the primary outcome. Follow-up involves assessing pain control, patient satisfaction, and economic factors. The trial includes adults aged 18 to 89 years and excludes patients with certain fracture types, chronic opioid use, or other conditions that could affect results. Participation lasts through the post-operative period with regular assessments.
CONDITIONS
Randomized Controlled Trial for Ankle Fracture Pain Control
E
Eric Swart, MD
J
Jillian Kazley, MD
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Lahey Clinic
Lead 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 | Regional Anesthesia | Traditional Pain Control Care (No intervention) | Long‑Acting Local Anesthesia Cocktail |
|---|---|---|---|
| What it is | Ultrasound‑guided peripheral nerve block using 0.5% ropivacaine for sciatic and femoral/saphenous nerves. | Standard postoperative pain regimen including gabapentin, oxycodone, acetaminophen and ibuprofen. | Local infiltration ‘cocktail’ of ropivacaine, clonidine, epinephrine and saline administered at incision site. |
| Role in trial | Intervention under investigation using regional nerve block. | Control arm reflecting current pain‑control practice. | Investigational local anesthetic cocktail assessed against traditional and block arms. |
| Primary purpose | To test whether nerve block improves postoperative pain control. | Baseline standard postoperative analgesia. | To evaluate effectiveness of local anesthetic cocktail for acute postoperative analgesia. |
| How it is given or performed | Ultrasound‑guided injection of ropivacaine around sciatic and femoral/saphenous nerves. | Standard oral or systemic medications as per regimen. | Intraoperative infiltration of ropivacaine‑based cocktail at surgical site. |
| Evidence beyond the trial | Regional anesthesia reduces opioid use and pain after foot and ankle surgery. | Multimodal systemic analgesia (NSAIDs, acetaminophen, opioids, regional/local techniques) is guideline‑recommended for postoperative pain control. | Long‑acting local anesthetic formulations can prolong postoperative analgesia, though liposomal versions show limited benefit over conventional agents. |
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...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo operative fixation of ankle fractures and receive one of three pain control methods: a local anesthetic cocktail injection, a perioperative nerve block, or standard oral narcotics.
1 surgical visit (in-person)
Duration - 72 postoperative hours
Participants are monitored for pain control effectiveness and use of oral narcotics during the first 72 hours after surgery.
Approximately 3 post-operative visits
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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