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Ultrasound-guided Nerve Blocks for the Sciatic and Saphenous Nerves: Characteristics of the Single Penetration Dual Injection (SPEDI) Technique

NCT01815372 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-11-06

No results posted yet for this study

Summary

Background and aims: Ultrasound-guided (USG) nerve blocks of the sciatic nerve (popliteal level = PL) and the saphenous nerve (mid-femoral level = MFL) provides analgesia following leg surgery. Traditionally two separate injections are performed. The aim was to describe a novel, faster USG block combination requiring only one skin penetration to block the sciatic and saphenous nerves; i.e. the SPEDI block = Single PEnetration Dual Injection.

Methods: A randomized, controlled and double-blinded trial. Following ethics committee approval 60 patients will be randomized to the administration of an USG SPEDI block compared to two separate USG blocks of the saphenous (MFL) and sciatic (PL) nerves. Blocks will be performed after induction of general anaesthesia. Outcome measures will be performance time (primary outcome measure), Post-Anaesthesia Care Unit pain scores (VAS scores 0-10), block difficulty level (easy, middle, difficult), opioid consumption (in the PACU), serum-ropivacaine pharmacokinetics (blood sample 0-180 minutes). Both block combinations will be evaluated by MR imaging (MRI).

Hypothesis: The USG SPEDI block combination is expected to be performed significantly faster without moving the leg, and achieve successful perioperative pain management. The SPEDI block may find important use in the emergency setting.

Conditions

  • Lower Leg Surgery, e.g. Ankle Fractures

Interventions

PROCEDURE

Single penetration dual injection (SPEDI) block technique to block the sciatic and the saphenous nerve with one needle penetration of the skin

PROCEDURE

The classical popliteal sciatic nerve block combined with the mid-femoral saphenous nerve block

Sponsors & Collaborators

  • Bispebjerg Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-04-30
Completion
2013-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01815372 on ClinicalTrials.gov