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N/A N=32 Randomized Triple-blind Treatment

Evaluation of Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block After Ankle Surgery

Orthopedic Surgery of Lower Extremity

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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