Pain, PostoperativePhase 4NCT02967172
Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures
A Phase 4 study testing Ropivacaine, Epinephrine and Morphine in people with Pain, Postoperative and Ankle Fractures, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pain, Postoperative, Ankle Fractures
- What is being tested?
- Ropivacaine, Epinephrine and Morphine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 21 Sep 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consenting patients 18 years of age and older with operative, closed, rotational ankle fractures treated with internal fixation.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Postoperative, Ankle Fractures
- Being tested
- Ropivacaine, Epinephrine, Morphine, 0.9% sodium chloride solution
- Medical subject headings
- Pain, Postoperative, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
EpinephrineDrug
Also called Adrenalin
MorphineDrug
Also called Duramorph
0.9% sodium chloride solutionDrug
Also called 0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Total opioid consumption expressed in morphine equivalent dose will be recorded, including IV and oral opioids, in the first 24 hours post-surgery.
Measured: At 24 hours post-surgery & during the total time of inpatient stay to dischage
Post-operative Length of Stay
Number of days in the hospital following surgery
Measured: From immediately following surgery to 90 days after.
Patients Returning Home Following Surgery
Number of patients returning to their home following discharge, vs. going to a rehabilitation or skilled nursing facility
Measured: Following hospital discharge from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startOct 2016
- Primary completion21 Sep 2018
- Study completion21 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Hancock, MD, Principal investigator, Resident Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967172
- Sponsor's protocol ID
- 201608737
- Status last verified
- Dec 2023
- First submitted
- 27 Oct 2016
- Last updated
- 15 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02967172
- Acronym / sponsor ID
- 201608737
- Conditions
- Pain, Postoperative, Ankle Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Posted 15 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-incisional injection | Experimental | Drug: Ropivacaine, Drug: Epinephrine, Drug: Morphine, Drug: 0.9% sodium chloride solutionA 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". |
| Control | No intervention | –Ankle fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consenting patients 18 years of age and older with operative, closed, rotational ankle fractures treated with internal fixation.
Key exclusion criteria (13 listed)
- Patients with any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineAlso: Naropin | Drug | Peri-incisional injection |
| EpinephrineAlso: Adrenalin | Drug | Peri-incisional injection |
| MorphineAlso: Duramorph | Drug | Peri-incisional injection |
| 0.9% sodium chloride solutionAlso: 0.9% normal saline | Drug | Peri-incisional injection |
Primary outcome
Change in Post-operative Visual Analog Pain Scores (VAS)
Time frame: Immediately following surgery, then every 4 hours following surgery for 48 hours post-surgery.
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.
3 secondary outcomes
Opioid Use in First 24 Hours Post-surgery
Time frame: At 24 hours post-surgery & during the total time of inpatient stay to dischage
Post-operative Length of Stay
Time frame: From immediately following surgery to 90 days after.
Patients Returning Home Following Surgery
Time frame: Following hospital discharge from surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Hancock, MD principal investigator
Resident Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine, Epinephrine and Morphine in people with Pain, Postoperative and Ankle Fractures, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-operative Visual Analog Pain Scores (VAS) (time frame: Immediately following surgery, then every 4 hours following surgery for 48 hours post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.