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This pilot study will test the hypothesis that prolonged regional peripheral nerve block will reduce development of chronic pain in patients undergoing surgery for ankle fracture compared to standard of care. Subjects will be followed for one year.
This pilot study will test the hypothesis that prolonged regional peripheral nerve block will reduce development of chronic pain in patients undergoing surgery for ankle fracture. Regional nerve block using local anesthetics delivered by ambulatory pump is used in some types of surgeries but is not routine for ankle fracture patients in our hospitals. Patients will be randomized to standard care (single shot peripheral nerve block prior to surgery) or experimental (the same single shot nerve block, followed by continuous popliteal nerve block with ropivacaine starting just after surgery). The primary outcome will be scores on a validated ankle/foot pain questionnaire that includes questions on function. Subjects will be followed for one year. Secondary outcome will be postoperative opioid use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Active Comparator | Single injection of ropivacaine immediately prior to surgery |
|
| Ropivacaine plus Nerve Block | Experimental | Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Single injection of ropivacaine immediately prior to surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score at 12 Months - Experimental Group vs. Control Group | Patients will complete Self-Administered Foot and Ankle Questionnaire (SEFAS) at 12 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome. | at 12 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score at 2 Weeks - Experimental Group vs. Control Group | Patients will complete Self-Administered Foot and Ankle Questionnaire at 2 weeks post surgery. For this instrument, 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome | at 2 weeks post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun-Ming Zhang, MD, MSc | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45216 | United States | ||
| UC Health West Chester Hosptial |
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Patients scheduled for open reduction and fixation of an ankle fracture were recruited from hospitals and outpatient surgery centers associated with the University of Cincinnati. Recruitment was delayed by a national ropivacaine shortage. Recruitment occurred between May 2018 and June 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Single injection of ropivacaine immediately prior to surgery Ropivacaine: Single injection of ropivacaine immediately prior to surgery. |
| FG001 | Ropivacaine Pump | Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Ropivacaine: Single injection of ropivacaine immediately prior to surgery. Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Single injection of ropivacaine immediately prior to surgery Ropivacaine: Single injection of ropivacaine immediately prior to surgery. |
| BG001 | Ropivacaine Pump |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score at 12 Months - Experimental Group vs. Control Group | Patients will complete Self-Administered Foot and Ankle Questionnaire (SEFAS) at 12 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome. | 2 subjects in standard care group were lost to follow-up and did not complete 12 month questionnaire but their questionnaires from earlier time points were included in the analyses. | Posted | Mean | Standard Deviation | units on a scale | at 12 months post surgery |
|
Subjects were contacted daily by phone for the first five days after surgery (which corresponded to the duration of ambulatory ropivacaine pump use for subjects in the experimental group). Medical chart records were reviewed for adverse events for 3 months following the surgery.
The protocol incorporated FDA adverse event definitions and Good Clinical Practices.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | Single injection of ropivacaine immediately prior to surgery Ropivacaine: Single injection of ropivacaine immediately prior to surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| wound dehiscence | Surgical and medical procedures | Non-systematic Assessment |
A problem encountered was that only 1 of the 6 subjects in the pump group received the full 5 days of treatment. The others discontinued using the pump early, primarily due to problems with catheter dislodgement/leakage. As specified in the statistical analysis plan, these subjects were all analyzed with intent-to-treat protocol and are included in the pump group data presented. Also, by chance, the distribution of males and females between the group was quite uneven.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jun-Ming Zhang, MD, MSc | University of Cincinnati | 5135582427 | jun-ming.zhang@uc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2018 | Dec 11, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2017 | Dec 20, 2017 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D009407 | Nerve Block |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Nerve block | Procedure | insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump. |
|
|
| Pain Score at 3 Months - Experimental Group vs. Control Group |
Patients will complete Self-Administered Foot and Ankle Questionnaire at 3 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome. |
| at 3 months post surgery |
| Pain Score at 6 Months - Experimental Group vs. Control Group | Patients will complete Self-Administered Foot and Ankle Questionnaire at 6 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome. | at 6 months post surgery |
| Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group | Incidence of chronic ankle pain diagnoses one year after surgery obtained from the medical record was originally planned but proved difficult to obtain. Here we provide the number of patients with a 12 month Self-Administered Foot and Ankle Questionnaire score lower than 40 at the 12 month time point. For this instrument, 48 = no pain or disability; 0 = maximum pain and disability. Scores of 40 below were interpreted to indicate ongoing ankle pain of significance for pain and function, for example, at least 8 of the 12 questions being scored less than the optimal value of 4. Scores from 40 to 48 were interpreted as indicating normal or near normal function of the affected ankle. | at 1 year post surgery |
| West Chester |
| Ohio |
| 45069 |
| United States |
Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.
Ropivacaine: Single injection of ropivacaine immediately prior to surgery.
Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI (body mass index) | Mean | Standard Deviation | kg/m^2 |
|
Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Ropivacaine: Single injection of ropivacaine immediately prior to surgery. Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump. |
|
|
|
| Secondary | Pain Score at 2 Weeks - Experimental Group vs. Control Group | Patients will complete Self-Administered Foot and Ankle Questionnaire at 2 weeks post surgery. For this instrument, 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome | Posted | Mean | Standard Deviation | units on a scale | at 2 weeks post surgery |
|
|
|
|
| Secondary | Pain Score at 3 Months - Experimental Group vs. Control Group | Patients will complete Self-Administered Foot and Ankle Questionnaire at 3 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome. | Posted | Mean | Standard Deviation | units on a scale | at 3 months post surgery |
|
|
|
|
| Secondary | Pain Score at 6 Months - Experimental Group vs. Control Group | Patients will complete Self-Administered Foot and Ankle Questionnaire at 6 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome. | Posted | Mean | Standard Deviation | units on a scale | at 6 months post surgery |
|
|
|
|
| Secondary | Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group | Incidence of chronic ankle pain diagnoses one year after surgery obtained from the medical record was originally planned but proved difficult to obtain. Here we provide the number of patients with a 12 month Self-Administered Foot and Ankle Questionnaire score lower than 40 at the 12 month time point. For this instrument, 48 = no pain or disability; 0 = maximum pain and disability. Scores of 40 below were interpreted to indicate ongoing ankle pain of significance for pain and function, for example, at least 8 of the 12 questions being scored less than the optimal value of 4. Scores from 40 to 48 were interpreted as indicating normal or near normal function of the affected ankle. | Posted | Count of Participants | Participants | at 1 year post surgery |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Ropivacaine Pump | Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Ropivacaine: Single injection of ropivacaine immediately prior to surgery. Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump. | 0 | 6 | 0 | 6 | 3 | 6 |
| metalic taste around lips | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Lightheadedness, nausea,headache | General disorders | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D000588 |
| Amines |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |