Randomized Controlled Trial for Ankle Fracture Pain Control
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03696199|
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : August 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Ankle Fractures||Drug: Long-Acting Local Anesthesia Drug: Regional Anesthesia||Phase 4|
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:
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective, Randomized Trial Evaluating Regional Anesthesia, Long-Acting Local Anesthesia, and Traditional Care for Pain Control of Operatively Treated Ankle Fractures|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||June 1, 2023|
No Intervention: Traditional Pain Control Care
Standard of care post-operative pain control with oral narcotics
Experimental: Regional Anesthesia
Single injection perioperative peripheral nerve block + followed by administration of oral narcotics on a need-based system
Drug: Regional Anesthesia
0.5% ropivicaine - 30mL each sciatic and femoral/saphenous nerve, ultrasound guided
Other Name: Ropivicaine
Experimental: Long-Acting Local Anesthesia
Subcutaneous local cocktail injection + followed by administration of oral narcotics on a need-based system
Drug: Long-Acting Local Anesthesia
The cocktail consists of:
The total amount of solution prepared is 50mL, but typically 30mL is used based on the size of the incision. The total volume administered will be recorded.
Other Name: Local Cocktail
- Oral Narcotics / Morphine Milligram Equivalents (MME) given [ Time Frame: 72 postoperative hours ]The medical record (EPIC) will be used to determine the total morphine equivalents given to the patient post-surgery, including recovery unit administration of narcotics in the immediate post-operative period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696199
|Contact: Eric Swart, MDfirstname.lastname@example.org|
|Contact: John Garfi, MSemail@example.com|
|United States, Massachusetts|
|Lahey Hospital & Medical Center||Recruiting|
|Burlington, Massachusetts, United States, 01805|
|Contact: Eric Swart, MD 781-744-2629|
|Principal Investigator:||Eric Swart, MD||Lahey Hospital & Medical Center|