Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain, Orthopedic |
| Therapuetic Areas: | Musculoskeletal, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 11/24/2018 |
| Start Date: | October 2016 |
| End Date: | September 21, 2018 |
Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures: A Randomized Controlled Trial
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.
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.
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.
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.
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
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