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Completed

NCT Number: NCT01815372

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

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.

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Key information

Conditions

Lower Leg Surgery, e.g. Ankle Fractures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, 2400 NV, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • lower leg surgery
  • American Society of Anesthesiologist (ASA) score I-III
  • Can cooperate in the study
  • Speaks and understand the Danish language
  • General anesthesia

Exclusion criteria

  • Intake of oral morphine above 40 mg per day
  • Know allergy to ropivacaine
  • Abuse of alcohol or other substance abuse
  • Neuropathy
  • Pregnant
  • Nerve block contraindicated

Treatment and study plan

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

Procedure

Primary outcomes

  1. Performance time (seconds and minutes). Time measurement from the time the ultrasound transducer is placed on the skin and until the needle is taken out of the body.

    Time frame: The measurement (seconds and minutes) will take place in the operating room. This will normally be within a time frame of 1 minute to 10 minutes.

    The time measurement is done with a normal clock - measuring seconds and minutes.

Secondary outcomes

  1. Pain score (VAS score 0-10).

    Time frame: When the patient are evaluated in the recovery unit upon arrival and when the patient is discharged from the recovery unit. This means from time 0 hours (arrival in the PACU) and normally until 2 hours after arrival in the PACU.

  2. Sensory dermatome testing.

    Time frame: Normally until 2 hours postoperatively.

    Sensory dermatome testing is done with cold ethanol on skin test. All dermatomes on the leg and foot are tested, and there is a comparison of the outcome between the operated leg and the not-operated leg.

Other outcomes

  1. Opioid consumption (micrograms of sufentanil) in total in the recovery unit.

    Time frame: Normally from 0 hours until 2 hours after arrival in the recovery unit.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 21, 2013
Registry last updated
Nov 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.