N/A
N=32
Evaluation of Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block After Ankle Surgery
Orthopedic Surgery of Lower Extremity
Bottom Line
View on ClinicalTrials.gov: NCT01167907 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Verbal Pain Scores — 4.2; 5.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 0.2% ropivacaine (Device); saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Verbal Pain Scores |
4.2; 5.4 | — |
| SECONDARY Opioid Use |
35.1; 33.3 | — |
| SECONDARY Nausea |
4; 1 | — |
| SECONDARY Vomiting |
2; 0 | — |
| SECONDARY Sleep Disturbance |
1.3; 1.6 | — |
| SECONDARY Reduction of Quadriceps Strength |
48.1; 37.3 | — |
Summary
A nerve block catheter is a small tube placed next to a nerve through a needle, and the needle is then removed. Numbing medicine is dripped through the tube to reduce pain sensation from the nerve.
The purpose of this research study is to test whether the placement of a second nerve block catheter, rather than a single injection for the saphenous nerve block will improve pain relief and/or reduce pain medication needed after surgery enough to justify two nerve block catheters.
There are two nerves that carry pain sensations from the ankle, the large (sciatic) nerve and the smaller (saphenous) nerve. Patients undergoing ankle fusion or fracture surgery at Wake Forest University typically have a nerve block catheter placed next to the sciatic nerve to give local anesthetic (numbing medicine) for 24-72 hours. In addition, a single injection of local anesthetic is usually performed to block the saphenous nerve for 12-16 hours postoperatively.
Eligibility Criteria
Inclusion Criteria
- surgery for unilateral ankle arthrodesis
- surgery for open reduction and internal fixation of bi/tri malleolar fracture
Exclusion Criteria
- coagulation abnormalities
- history of opioid addiction
- current chronic pain therapy with high dsoe opioid
- allergy to study medication
- failure of the sciatic nerve catheter
Data sourced from ClinicalTrials.gov (NCT01167907). 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.