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NCT01167907 · ClinicalTrials.gov registry record · NA
Evaluation of Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block After Ankle Surgery
A NA study of Orthopedic Surgery of Lower Extremity, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT01167907: Completed NA study of Orthopedic Surgery of Lower Extremity, sponsored by Wake Forest University Health Sciences.
NCT01167907 is a NA study of Orthopedic Surgery of Lower Extremity that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01167907, a NA study of Orthopedic Surgery of Lower Extremity, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The primary endpoint of this study will be a reduction of the rest and incident verbal pain scores 48hpost-nerve blockade when the primary saphenous single-shot block is expected to have resolved. "Verbal Pain Score" is the outcome measure applied by asking patients to rate their level of pain. The commonly used 11-point numerical pain rating, with 0-10 range is defined as the following: Zero (0) is used to rate "no pain" and is the best score Ten (10) is used to rate "the worst pain imaginable
Conditions Studied
Interventions
- DRUG saline
- DEVICE 0.2% ropivacaine
Study Locations (1)
North Carolina
- Wake Forest University Baptist Medical Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2010-07 |
| Est. Completion | 2017-09-07 |
| Phase | NA |
What the finished NCT01167907 record still lists
NCT01167907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Orthopedic Surgery of Lower Extremity appearing as the primary indexed condition, and to 2 interventions - of which saline is the first listed.
NCT01167907 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01167907 about?
NCT01167907 is a clinical study titled "Evaluation of Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block After Ankle Surgery". 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,...
What is the current status of trial NCT01167907?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2010-07. Estimated completion is 2017-09-07.
What conditions does trial NCT01167907 study?
This clinical trial studies the following conditions: Orthopedic Surgery of Lower Extremity.
What interventions are being tested in trial NCT01167907?
The interventions under investigation include: saline (DRUG), 0.2% ropivacaine (DEVICE).
Who is sponsoring clinical trial NCT01167907?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01167907 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01167907's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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