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N/A N=70 Randomized Double-blind Treatment

Comparing Through-the-Needle With Suture-Method Catheter Designs for Popliteal Nerve Blocks

Regional Anesthesia · Sciatic Nerve Block

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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