Clinical trial NCT02967172: Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures
Official title: Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Ankle Fractures
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Periarticular fractures (bone breaks extending into the joint surface) treated by orthopaedic surgeons are associated with significant pain in the post-operative period, often requiring high doses of opioid analgesics. In recent years, the high risk of misuse, abuse, and death associated with prescription opioid use has become increasingly evident.

Although physicians are being advised to avoid administration of opioid prescriptions, alternative pain management options are limited. Currently, there is a need to investigate different pain management models in order to provide safe and effective pain relief during the post-operative period. The investigators aim to evaluate the effectiveness of peri-incisional multimodal injections as an alternative post-operative pain control method in orthopaedic trauma patients with operative ankle fractures. Approximately 200 patients will be randomized to either receive or not receive intra-operative injections in addition to standard opioid analgesic regimens. Post-operative pain management outcomes will be assessed and compared between the 2 study groups to determine effectiveness of the injections. The proposed study will build upon related work to advance post-operative pain control regimens in orthopaedic surgery. Goals include the reduction of unnecessary patient suffering, reliance on opioids, and length of stay, while improving patient experience. These aims will be accomplished through the expansion of currently used multimodal periarticular injections from populations undergoing elective surgery to orthopaedic trauma patients with rotational ankle fractures.

The study design is a prospective, double-blinded, randomized controlled trial. Patients included in the study will be randomly assigned to one of two treatment groups: intra-operative multimodal periarticular injection or control (no injection). The peri-incisional injection will consist of ropivacaine, epinephrine, and morphine. All pharmacologic agents in the anesthetic cocktail are FDA approved and have been previously used in combination during other types of orthopaedic surgeries.

All patients included in the study will receive standard post-operative opioid analgesic regimens, administered 'per needed', regardless of their assigned treatment group per study protocol. ≥ 40 patients will be randomly assigned to each group. The patients enrolled in the investigation as well as health care professionals performing post-operative assessments and collecting data will be blinded to treatment allocation. The feasibility of multimodal peri-incisional injections is supported by their current efficacy in populations undergoing elective orthopedic surgeries. These injections may be equally effective at reducing pain compared to regional anesthesia with continuous infusions, and single-shot nerve blocks.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Post-operative Visual Analog Pain Scores (VAS)
timeFrame: Immediately following surgery, then every 4 hours following surgery for 48 hours post-surgery.
Secondary outcomes:
measure: Opioid Use in First 24 Hours Post-surgery
timeFrame: At 24 hours post-surgery & during the total time of inpatient stay to dischage
measure: Post-operative Length of Stay
timeFrame: From immediately following surgery to 90 days after.
measure: Patients Returning Home Following Surgery
timeFrame: Following hospital discharge from surgery
Other outcomes:
measure: Medication-related Side Effects
timeFrame: From immediately following surgery to 7 days after.
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: Resident Physician
name: Kyle Hancock, MD
role: PRINCIPAL_INVESTIGATOR
References: