A Phase 4 interventional study of Ropivacaine and Nerve block in Chronic Pain, Ankle Fracture Surgery and Regional Anesthesia, sponsored by University of Cincinnati. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-02.
Sponsored by University of Cincinnati · Phase 4, Interventional, and Treatment
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.
2,930 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.
This study's enrollment of 14 is below the median of 60 across 2,160 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
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Exclusion Criteria:
Single injection of ropivacaine immediately prior to surgery
Drug: Ropivacaine
Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.
Drug: Ropivacaine · Procedure: Nerve block
Single injection of ropivacaine immediately prior to surgery.
Also known as: Naropin
insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Also known as: no other name
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.
Time frame: at 12 months post surgery
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
Time frame: at 2 weeks post surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: at 1 year post surgery
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.
| Milestone | Standard Care | Ropivacaine Pump |
|---|---|---|
| Started | 8 | 6 |
| 12 month pain questionnaire | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 2 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
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.
| units on a scale | Standard Care | Ropivacaine Pump |
|---|---|---|
| Pain Score at 12 Months - Experimental Group vs. Control Group | 36.33 ± 9.543 | 44.00 ± 1.414 |
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
| units on a scale | Standard Care | Ropivacaine Pump |
|---|---|---|
| Pain Score at 2 Weeks - Experimental Group vs. Control Group | 16.22 ± 6.637 | 13.67 ± 2.082 |
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.
| units on a scale | Standard Care | Ropivacaine Pump |
|---|---|---|
| Pain Score at 3 Months - Experimental Group vs. Control Group | 26.25 ± 7.869 | 35.71 ± 5.489 |
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.
| units on a scale | Standard Care | Ropivacaine Ppump |
|---|---|---|
| Pain Score at 6 Months - Experimental Group vs. Control Group | 34.00 ± 9.011 | 37.67 ± 3.724 |
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.
| Participants | Standard Care | Ropivacaine Pump |
|---|---|---|
| SEFAS Score >=40 | 3 | 6 |
| SEFAS Score <40 | 3 | 0 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Care | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Ropivacaine Pump | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Event | Standard Care | Ropivacaine Pump |
|---|---|---|
| metalic taste around lipsInjury, poisoning and procedural complications | 0/8 | 1/6 |
| Lightheadedness, nausea,headacheGeneral disorders | 0/8 | 1/6 |
| ColitisGastrointestinal disorders | 0/8 | 1/6 |
| wound dehiscenceSurgical and medical procedures | 1/8 | 0/6 |
| Age, Categorical(Participants) | Standard Care | Ropivacaine Pump | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 6 | 14 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Standard Care | Ropivacaine Pump | Total |
|---|---|---|---|
| Mean | 44.13 ± 10.09 | 43.17 ± 15.41 | 43.71 ± 12.10 |
| Sex: Female, Male(Participants) | Standard Care | Ropivacaine Pump | Total |
|---|---|---|---|
| Female | 2 | 5 | 7 |
| Male | 6 | 1 | 7 |
| Race (NIH/OMB)(Participants) | Standard Care | Ropivacaine Pump | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 7 | 5 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Standard Care | Ropivacaine Pump | Total |
|---|---|---|---|
| United States | 8 | 6 | 14 |
| BMI (body mass index)(kg/m^2) | Standard Care | Ropivacaine Pump | Total |
|---|---|---|---|
| Mean | 31.17 ± 5.538 | 31.53 ± 3.886 | 31.32 ± 4.728 |
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