Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures

NCT02967172 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 201608737
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy and safety of a peri-articular multimodal injection for post-operative pain control following operative management of closed, rotational ankle fractures. Enrolled subjects will be randomized to either receive or not receive intra-operative injections in addition to standard opioid analgesic regimens. Patients will be treated with standard of care surgical techniques by the treating orthopaedic surgeon for the patient's specific fracture pattern. The patients randomized into the injection cohort will receive a 25cc intra-operative injection with 200 mg ropivacaine, 0.6 mg epinephrine, 5 mg and morphine into the local superficial and deep peri-incisional tissues while under general anesthesia. Total post-operative opioid consumption expressed in morphine equivalent dose will be recorded, including IV and oral opioids. Time in hours from operation conclusion to discharge and discharge disposition (to where the patient is discharged) will also be recorded. Post-operative pain scores will be assessed and recorded in the immediate post-operative period and every 4 hours subsequently until the patient is discharged. Medication related side effects will be monitored. The investigators hypothesize that the injection cohort will have reduced pain scores, lower narcotic requirements, shorter length of stay, and be more likely to discharge to home following surgery.

Conditions

Pain, Postoperative; Ankle Fractures

Outcome Measures

Primary Outcomes (1)

• Change in Post-operative Visual Analog Pain Scores (VAS)

  The primary outcome was VAS pain over the first 48 hours postoperatively. Patients reported pain with use of a 100-mm VAS, with 0-mm being no pain and 100-mm being the most extreme pain imaginable. A higher score indicates worse pain. Scores were reported as mean values at 24 hours post-surgery and 48 hours post-surgery.

  Immediately following surgery, then every 4 hours following surgery for 48 hours post-surgery.

Secondary Outcomes (3)

• Opioid Use in First 24 Hours Post-surgery

  At 24 hours post-surgery & during the total time of inpatient stay to dischage

• Post-operative Length of Stay

  From immediately following surgery to 90 days after.

• Patients Returning Home Following Surgery

  Following hospital discharge from surgery

Other Outcomes (1)

• Medication-related Side Effects

  From immediately following surgery to 7 days after.

Study Arms (2)

Peri-incisional injection

EXPERIMENTAL

A single, 25 cc multimodal analgesic cocktail will be injected following completion of ankle fracture fixation/instrumentation while the patient remains under general anesthesia and prior to skin closure. The injection will be administered as such: * 20 mL injected into the peri-incisional soft tissues in a circumferential fashion * 5mL injected into the ankle joint This cocktail includes 200 mg of 0.8% ropivacaine, 0.6 mg of epinephrine, 5 mg of morphine sulfate, and sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection. Interventions: Drug: Ropivacaine Drug: Epinephrine Drug: Morphine Drug: 0.9% sodium chloride solution Following surgery, patients in the treatment and non-treatment groups will both be provided with the same intravenous (patient-controlled analgesia) and oral pain medications scheduled "per needed".

Drug: Ropivacaine; Drug: Epinephrine; Drug: Morphine; Drug: 0.9% sodium chloride solution

Control

NO INTERVENTION

Ankle fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.

Interventions

Ropivacaine DRUG

Also known as: Naropin

Peri-incisional injection

Epinephrine DRUG

Also known as: Adrenalin

Peri-incisional injection

Morphine DRUG

Also known as: Duramorph

Peri-incisional injection

0.9% sodium chloride solution DRUG

Also known as: 0.9% normal saline

Peri-incisional injection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consenting patients 18 years of age and older with operative, closed, rotational ankle fractures treated with internal fixation.

You may not qualify if:

• Patients with any of the following:
• Allergy or medical contraindication to any of the study medications
• Pregnant women
• Diagnosed dementia
• Preexisting opioid or illicit drug dependency
• Major neuromuscular deficit
• Severe systemic disorder (heart failure, respiratory failure, kidney failure, liver failure, or a clotting disorder)
• Major head trauma
• Concomitant distracting injury
• Other surgical intervention in the study period (1 week)
• Revision operations
• Insists to receive peripheral nerve blocks for surgical anesthesia
• Refusal to participate

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Ankle Fractures

Interventions

Ropivacaine; Epinephrine; Morphine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Michael Willey, MD
• Organization: University of Iowa

michael-willey@uiowa.edu

319-384-8452

Study Officials

• Kyle Hancock, MD

  Resident Physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 18, 2016
• Study Start: October 1, 2016
• Primary Completion: September 21, 2018
• Study Completion: September 21, 2018
• Last Updated: December 15, 2023
• Results First Posted: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)