Randomized Controlled Trial for Ankle Fracture Pain Control

Ankle Fractures Clinical Trial

Official title: A Prospective, Randomized Trial Evaluating Regional Anesthesia, Long-Acting Local Anesthesia, and Traditional Care for Pain Control of Operatively Treated Ankle Fractures

Status Recruiting

Clinical Trial Summary

This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.

Clinical Trial Description

This study is a multicenter, three armed, prospective randomized control trial studying the effect of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.

Primary Hypothesis Driven Aims:

1. Determine the effectiveness of a local anesthesia "cocktail" compared to regional block or standard of care in controlling pain in operatively treated ankle fractures. Nearly one out of ten fractures treated by both orthopaedic traumatologists and general orthopaedic surgeons taking call are ankle fractures. As such, effective pain control in this group of patients represents an opportunity to make a large impact, especially in the context of the current opioid epidemic. Improved pain control can help improve patient satisfaction, outcomes, decrease length of stay, cost of care, and complications associated with traditional narcotic use.

• Hypothesis 1A: Patients receiving the intraoperative cocktail will have improved post-operative pain control compared to those receiving a peri-operative nerve block or standard of care.

• Hypothesis 1B: Patients receiving the intraoperative cocktail or peri-operative nerve block will have improved post-operative pain control when compared to standard of care.

• Null Hypothesis 1: There will be no difference in post-operative pain control between all treatment arms.

2. Determine the economic impact of cocktail and regional blocks in ankle fractures. A common concern with the use of regional blocks is the cost of the additional procedure, along with logistic delays which are associated with coordinating a separate procedure. This study would provide valuable data about the additional costs associated with regional blocks and with cocktail administration which could help aid in making economically conscious treatment decisions.

• Hypothesis 2: Local cocktail administration will have significantly lower costs than regional block, and not be significantly more expensive than standard of care.

• Null Hypothesis 2: There is no difference in cost between the modalities.

Secondary Aim:

Demonstrate the use of long-acting local anesthetic as a viable pain management strategy in fracture surgery. Although long-acting local anesthetics have an established track record in arthroplasty, there is a paucity of evidence guiding their use in fractures. Small case series in trauma and foot/ankle patients have been encouraging, but a rigorously conducted, prospective trial in a relatively homogeneous group could generate pilot data to validate the use of long acting local anesthetics in fracture surgery. This knowledge may be translatable to other extremity injuries as well, having a greater impact than the scope of the proposed trial. ;

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

• NCT number: NCT03696199
• Study type: Interventional
• Source: Lahey Clinic
• Contact: Eric Swart, MD
• Phone: 781-744-2629
• Email: eric.f.swart@lahey.org
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2020
• Completion date: September 1, 2025