N/A
N=70
Comparing Through-the-Needle With Suture-Method Catheter Designs for Popliteal Nerve Blocks
Regional Anesthesia · Sciatic Nerve Block
Bottom Line
View on ClinicalTrials.gov: NCT03442036 ↗Enrolled (actual)
70
Serious AEs
1.4%
Results posted
Mar 2020
Primary outcome: Primary: Average Pain — 2.7; 3.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Suture-Method Technique (Device); Through-the-Needle Technique (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain |
2.7; 3.4 | — |
| SECONDARY Opioid Consumption |
5.0; 10; 10; 10 | — |
| SECONDARY Worst Pain |
5.4; 5.8; 5.6; 5.6 | — |
Summary
Following painful surgical procedures, postoperative analgesia is often provided with a single-injection peripheral nerve block. Hothe investigatorsver, even with the longest-acting FDA-approved local anesthetic currently available-bupivacaine-the block duration is measured in hours, while the surgical pain may persist for days. A continuous peripheral nerve block allows a prolonged block, consisting of a percutaneously-inserted catheter with its orifice adjacent to a target nerve/plexus through which local anesthetic may be administered. Two basic perineural catheter designs currently exist: (1) catheters that are inserted either through or over a straight hollow-bore needle; and, (2) catheters that are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve ("suture-method" design). To date, a comparison of the relative risks and benefits of these two designs have not been investigated. The investigators therefore propose a randomized, observer-masked, controlled, parallel-arm, clinical trial to compare these two catheter designs when used to provide post-surgical analgesia following foot and ankle surgery.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing ambulatory foot or ankle surgery with a popliteal perineural catheter for postoperative analgesia.
Exclusion Criteria
- Pregnancy
- Inability to communicate with research staff
- Incarceration
- Clinically apparent neuropathy in the operative extremity
- Chronic high dose opioid use
- History of opioid abuse
- Concurrent surgery outside the block distribution
- Patients with nerves deeper than 5 cm from the skin
Data sourced from ClinicalTrials.gov (NCT03442036). 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.