Phase 4
Completed N=14
Anesthesia for Pain After Ankle Fracture Surgery
Postoperative Pain · Ankle Fracture Surgery · Regional Anesthesia
Source: ClinicalTrials.gov NCT02950558 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Pain Score at 12 Months - Experimental Group vs. Control Group — 36.33; 44.00 units on a scale — p=0.1269
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score at 12 Months - Experimental Group vs. Control Group |
36.33; 44.00 | 0.1269 |
| SECONDARY Pain Score at 2 Weeks - Experimental Group vs. Control Group |
16.22; 13.67 | 0.8808 |
| SECONDARY Pain Score at 3 Months - Experimental Group vs. Control Group |
26.25; 35.71 | 0.0382 sig |
| SECONDARY Pain Score at 6 Months - Experimental Group vs. Control Group |
34.00; 37.67 | 0.4696 |
| SECONDARY Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group |
3; 6; 3; 0 | 0.1818 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02950558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.