A study to determine whether aspiration of hematoma and hemarthrosis in an ankle fracture would decrease pain and the need for pain medication found that aspiration did not result in decreased pain scores or opioid usage in patients.
The results of the prospective, double-blind, randomized placebo-controlled trial were presented by S. Andrew Sems, MD, of the Mayo Clinic, at the 2014 annual meeting of the Orthopaedic Trauma Association.
The hypothesis that aspiration would have a beneficial effect ostensibly held promise because the procedure has been well described for acute fractures in other parts of the body, most notably those of the femoral neck and the radial head. It has been shown to be effective in achieving favorable outcomes including improved function, decreased pain, and decreased pressure.
“Theoretically, aspiration lessens soft-tissue distension, resulting in the decreased pressure and pain,” Dr. Sems said. Yet, he added, “the relationship between swelling, fracture hematoma, hemarthrosis, and pain is not completely understood.”
The study involved 232 consecutive skeletally mature patients with isolated, closed ankle fractures. Of these, 108 patients opted not to participate, citing fear of needle puncture. Exclusion criteria included concomitant injuries that would affect patient pain rating, soft-tissue wounds precluding aspiration, and inability to follow up. The patients were randomized to receive either aspiration or a sham procedure.
The procedure was performed “preferably via the anterolateral portal,” Dr. Sems explained, but the anteromedial portal was also used in cases where the soft tissue over the anterolateral portal was compromised. A 22-gauge needle was inserted into the ankle joint and aspiration was performed until no further hemarthrosis could be removed. The sham procedure was performed by inserting the needle through the skin into the subcutaneous tissue but not piercing the fascia, and withdrawing after 10 seconds without removing any fluid.
Pain and opioid use were the primary outcomes recorded. Pain was rated on a 0 to 10 numerical rating scale (NRS); opioid pain medicine use was measured in oral morphine equivalents (OMEs). Pain scores were recorded at the time of presentation, prior to discharge from the emergency department (ED), and every 8 hours thereafter for the first 72 hours or until surgery, whichever was sooner, using a pain diary created specifically for this study. The quantity and timing of pain medicine use was also documented with the pain diary.
Investigators also calculated limb volume at the first follow-up or time of surgery (Fig. 1) and recorded 6-month Olerud-Molander and Short Musculoskeletal Function Assessment (SMFA) scores, along with complications, including infection and need for revision surgery or removal of hardware.
Patients were discharged from the ED with instructions to keep the limb elevated above the heart as much as possible and to be non–weight bearing. The ultimate care of the ankle fracture was based on the preference of the attending orthopaedic trauma surgeon. Patients treated nonsurgically were evaluated 1 week following injury, at which time the initial immobilization was temporarily removed, the soft tissues were inspected, and a volumetric measurement of both limbs was obtained.
For patients treated with surgical fixation, the timing of surgery was at the surgeon’s discretion and the patient’s desires without regard for the study. At the time of surgical intervention, following induction of anesthesia but prior to skin incision, a volumetric measurement of both limbs was obtained.
“Pain levels over time were compared between the aspiration and sham groups, and no statistically significant differences were seen at any time point,” Dr. Sems said.
In terms of opioid consumption, no statistically significant difference between groups was seen on any of the first three days after injury.
A comparison of mean limb volumes did not detect significant correlations; the injured limb was 12.9 percent (260 mL) larger than the noninjured limb in the aspiration group and 12.2 percent (239 mL) larger in the control group (P = 0.69).
No statistically significant differences were seen between the aspiration and control groups in complication or reoperation rates. Complications included nerve pain, pulmonary embolism, ankle stiffness, surgical wound infection requiring reoperation, and posttraumatic arthritis. Three reoperations were performed for implant removal.
Intra- vs. extracapsular implications?
Dr. Sems noted that previous studies focusing on pain, hematoma, and swelling have involved intra-articular and intracapsular fractures. For example, aspiration of hematoma in the setting of a radial head fracture has been found beneficial for pain relief. Aspiration for such injuries also was shown to improve range of motion in the elbow.
For femoral neck fractures, aspiration decreases intracapsular pressures in intracapsular fractures but causes no change to the pressure for extracapsular fractures.
“In the radial head and femoral neck, fracture hemarthrosis is entirely contained by the intact joint capsule,” Dr. Sems noted. “Ankle fractures functionally disrupt the ankle capsule, allowing the joint hemarthrosis to extravasate through the fracture site into an extracapsular location. This results in the prevention of the entire hemarthrosis to be aspirated, and that likely minimized the effect that aspiration could provide.”
Noting that previous studies have shown that intra-articular injection of local anesthetics provided average improvement in Visual Analog Scale scores of 3.4 to 4.6 points, he commented, “The goal of this study was to investigate the role that the presence of hemarthrosis contributed to the patient’s pain. By choosing to not inject local anesthetics, we have isolated the impact that the removal of the hemarthrosis alone has on pain and narcotic requirements.”
Strengths of the study, Dr. Sems said, include the “rigorous prospective, randomized, double-blind design.” Weaknesses include the high rate of patients who met study criteria but who opted to not participate in the study. “Additionally, we included patients treated both surgically and nonsurgically in this study,” he said.
“Despite these potential limitations, we believe the study question was answered definitively,” saidDr. Sems. “Aspiration of acute ankle fracture provides no demonstrable clinical benefit and cannot be recommended as an adjunctive therapy in the management of acute ankle fractures.”
Coauthors with Dr. Sems are Timothy J. Ewald, MD; Pamela K. Holte, CNP; Joseph R. Cass, MD; and William W. Cross III, MD. One or more of the authors reported potential conflicts of interest; visit www.aaos.org/disclosure for more information.
Terry Stanton is a senior science writer for AAOS Now. He can be reached at firstname.lastname@example.org
- Aspiration of hematoma and hemarthrosis has demonstrated a beneficial effect in decreasing pain for femoral neck and radial head fractures.
- This randomized, blinded study tested the hypothesis that such aspiration would have similar benefits for ankle fracture.
- Patients in the study who underwent aspiration did not demonstrate significant differences in the primary outcomes of pain and opioid consumption or in secondary outcomes such as limb volume and complications.
- The difference in the findings for ankle fractures versus those for femoral neck and radial head fractures appears to be related to whether fractures are extracapsular or intracapsular.