Ankle Fracture Surgery, Chronic Pain, Regional Anesthesia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGRopivacaine
Single injection of ropivacaine immediately prior to surgery.
PROCEDURENerve block
insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Referred for surgery for open reduction and internal fixation for ankle fracture
Exclusion criteria
* Unable to give informed consent in English * Unable to complete surveys in English * Unable to understand instructions for using pump in English * Unavailable for followup * Polytrauma; undergoing other surgeries or having other orthopedic injuries related to the precipitating cause of the ankle fracture * Infection * Peripheral vascular disease * Diabetes * Currently undergoing chemotherapy * Pregnancy * Currently lactating * Heart disease or heart rhythm disorder or taking anti-arrhythmic drugs * Severe renal impairment (Class 3 or worse kidney disease) * Liver disease (cirrhosis or liver failure) * Prior allergic reaction to any type of local anesthetic * Taking therapeutic doses of anti-coagulants or anti-platelet therapy (prophylactic doses started because of hospital admission are not an exclusion) * Currently taking antidepressants or other psychiatric medications * Single shot local nerve block prior to surgery was ineffective * Selected for neuraxial anesthesia rather than general anesthesia for the open reduction surgery * Already receiving chronic analgesic therapy for a separate chronic pain condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score at 12 Months - Experimental Group vs. Control Group | at 12 months post surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score at 2 Weeks - Experimental Group vs. Control Group | at 2 weeks post surgery | 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 |
| Pain Score at 3 Months - Experimental Group vs. Control Group | at 3 months post surgery | 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. |
| Pain Score at 6 Months - Experimental Group vs. Control Group | at 6 months post surgery | 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. |
| Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group | at 1 year post surgery | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Single injection of ropivacaine immediately prior to surgery
Ropivacaine: Single injection of ropivacaine immediately prior to surgery. | 8 |
| 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. | 6 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Standard Care | Ropivacaine Pump | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 6 Participants | 14 Participants |
| Age, Continuous | 44.13 years STANDARD_DEVIATION 10.09 | 43.17 years STANDARD_DEVIATION 15.41 | 43.71 years STANDARD_DEVIATION 12.1 |
| BMI (body mass index) | 31.17 kg/m^2 STANDARD_DEVIATION 5.538 | 31.53 kg/m^2 STANDARD_DEVIATION 3.886 | 31.32 kg/m^2 STANDARD_DEVIATION 4.728 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 5 Participants | 12 Participants |
| Region of Enrollment United States | 8 participants | 6 participants | 14 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 6 Participants | 1 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 1 / 8 | 3 / 6 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 |
Outcome results
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.
Time frame: at 12 months post surgery
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Pain Score at 12 Months - Experimental Group vs. Control Group | 36.33 units on a scale | Standard Deviation 9.543 |
| Ropivacaine Pump | Pain Score at 12 Months - Experimental Group vs. Control Group | 44.00 units on a scale | Standard Deviation 1.414 |
p-value: 0.1269Wilcoxon (Mann-Whitney)
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.
Time frame: at 1 year post surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Care | Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group | SEFAS Score >=40 | 3 Participants |
| Standard Care | Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group | SEFAS Score <40 | 3 Participants |
| Ropivacaine Pump | Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group | SEFAS Score >=40 | 6 Participants |
| Ropivacaine Pump | Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group | SEFAS Score <40 | 0 Participants |
p-value: 0.1818Fisher Exact
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
Time frame: at 2 weeks post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Pain Score at 2 Weeks - Experimental Group vs. Control Group | 16.22 units on a scale | Standard Deviation 6.637 |
| Ropivacaine Pump | Pain Score at 2 Weeks - Experimental Group vs. Control Group | 13.67 units on a scale | Standard Deviation 2.082 |
p-value: 0.8808Wilcoxon (Mann-Whitney)
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.
Time frame: at 3 months post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Pain Score at 3 Months - Experimental Group vs. Control Group | 26.25 units on a scale | Standard Deviation 7.869 |
| Ropivacaine Pump | Pain Score at 3 Months - Experimental Group vs. Control Group | 35.71 units on a scale | Standard Deviation 5.489 |
p-value: 0.0382Wilcoxon (Mann-Whitney)
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.
Time frame: at 6 months post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Pain Score at 6 Months - Experimental Group vs. Control Group | 34.00 units on a scale | Standard Deviation 9.011 |
| Ropivacaine Pump | Pain Score at 6 Months - Experimental Group vs. Control Group | 37.67 units on a scale | Standard Deviation 3.724 |
p-value: 0.4696Wilcoxon (Mann-Whitney)