Randomized Controlled Trial for Ankle Fracture Pain Control

NCT03696199 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 20223040
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (1)

• Oral Narcotics / Morphine Milligram Equivalents (MME) given

  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.

  72 postoperative hours

Study Arms (3)

Traditional Pain Control Care

NO INTERVENTION

Standard of care post-operative pain control with oral narcotics

Regional Anesthesia

EXPERIMENTAL

Single injection perioperative peripheral nerve block + followed by administration of oral narcotics on a need-based system

Drug: Regional Anesthesia

Long-Acting Local Anesthesia

EXPERIMENTAL

Subcutaneous local cocktail injection + followed by administration of oral narcotics on a need-based system

Drug: Long-Acting Local Anesthesia

Interventions

Long-Acting Local Anesthesia DRUG

The cocktail consists of: * 0.5% Ropivicaine, 24.6 mL * Clonidine 100 mcg/mL, 0.4mL * Epinephrine 1mg/mL, 0.5mL * Saline to total volume of 50 mL (24.5mL of saline) 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.

Also known as: Local Cocktail

Long-Acting Local Anesthesia

Regional Anesthesia DRUG

0.5% ropivicaine - 30mL each sciatic and femoral/saphenous nerve, ultrasound guided

Also known as: Ropivicaine

Regional Anesthesia

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sustained a bimalleolar ankle fracture (OTA/AO type 44 A2, B2, C1, and C2 fracture) with surgery indicated and an approach with medial and lateral incisions planned Syndesmotic injuries will be included, due to the practical difficulty of reliably determining the presence of a syndesmotic injury preoperatively Trimalleolar ankle fractures where fixation of the posterior malleolus is not planned will also be included
• Isolated Injury

You may not qualify if:

• Unifocal malleolar fractures
• Bimalleolar fractures where fixation of only one malleolus is planned
• Posterior malleolus fractures requiring fixation
• Patients ineligible for a peripheral nerve block (e.g. concern for compartment syndrome)
• Open injury
• Patients treated with external fixation
• Neurologic condition that would confound results (e.g. peripheral neuropathy)
• Inability to consent
• Chronic opioid use
• History of opiate abuse
• Polytrauma as defined as additional boney injury, visceral injury or moderate soft tissue injury (requiring suture repair or other invasive procedure)
• Prisoners (unlikely to be accessible for follow-up)
• Pregnant patients
• Non-English-speaking subjects (post-operative data collection procedure involves conversations via phone calls. As we do not have access to translators for this research project, we will work exclusively with English-speaking subjects).
• Subjects unable to take the standard post-operative pain regimen that consists of gabapentin, oxycodone, acetaminophen, and ibuprofen.

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

RECRUITING

Related Publications (26)

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• De Maeyer J, Vanderplasschen W, Broekaert E. Quality of life among opiate-dependent individuals: A review of the literature. Int J Drug Policy. 2010 Sep;21(5):364-80. doi: 10.1016/j.drugpo.2010.01.010. Epub 2010 Feb 20.

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• Morrone LA, Scuteri D, Rombola L, Mizoguchi H, Bagetta G. Opioids Resistance in Chronic Pain Management. Curr Neuropharmacol. 2017 Apr;15(3):444-456. doi: 10.2174/1570159X14666161101092822.

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• Elkassabany N, Cai LF, Mehta S, Ahn J, Pieczynski L, Polomano RC, Picon S, Hogg R, Liu J. Does Regional Anesthesia Improve the Quality of Postoperative Pain Management and the Quality of Recovery in Patients Undergoing Operative Repair of Tibia and Ankle Fractures? J Orthop Trauma. 2015 Sep;29(9):404-9. doi: 10.1097/BOT.0000000000000344.

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• Cometa MA, Esch AT, Boezaart AP. Did continuous femoral and sciatic nerve block obscure the diagnosis or delay the treatment of acute lower leg compartment syndrome? A case report. Pain Med. 2011 May;12(5):823-8. doi: 10.1111/j.1526-4637.2011.01109.x.

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• Mar GJ, Barrington MJ, McGuirk BR. Acute compartment syndrome of the lower limb and the effect of postoperative analgesia on diagnosis. Br J Anaesth. 2009 Jan;102(1):3-11. doi: 10.1093/bja/aen330. Epub 2008 Nov 19.

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• Goldstein RY, Montero N, Jain SK, Egol KA, Tejwani NC. Efficacy of popliteal block in postoperative pain control after ankle fracture fixation: a prospective randomized study. J Orthop Trauma. 2012 Oct;26(10):557-61. doi: 10.1097/BOT.0b013e3182638b25.

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• Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4.

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• Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.

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MeSH Terms

Conditions

Ankle Fractures

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Eric Swart, MD

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Swart, MD

CONTACT

781-744-2629; eric.f.swart@lahey.org

Jillian Kazley, MD

CONTACT

781-744-2629; jillian.kazley@lahey.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 4, 2018
• Study Start: September 1, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)