Completed

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

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What is being tested

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

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

Procedure
Who is being recruted

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorBispebjerg Hospital
Last updated: November 6, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorBispebjerg Hospital
Last updated: November 6, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
American Society of Anesthesiologist (ASA) score I-III

Can cooperate in the study

General anesthesia

Speaks and understand the Danish language

Show More Criteria

6 exclusion criteria prevent from participating
Abuse of alcohol or other substance abuse

Intake of oral morphine above 40 mg per day

Know allergy to ropivacaine

Nerve block contraindicated

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
These are the patients that will be randomized to receive a SPEDI block of the sciatic and saphenous nerve with at single needle penetration of the skin

Group II

Active Comparator
These are the patients that will be randomized to the administration of a popliteal sciatic nerve block combined with a mid-femoral saphenous nerve block with two separate injections

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Bispebjerg Hospital

Copenhagen, DenmarkOpen Bispebjerg Hospital in Google Maps
CompletedOne Study Center