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

Bispebjerg Hospital

Status: Completed

Conditions: Lower Leg Surgery, e.g. Ankle Fractures

Treatments: Procedure: The classical popliteal sciatic nerve block combined with the mid-femoral saphenous nerve block; Procedure: Single penetration dual injection (SPEDI) block technique to block the sciatic and the saphenous nerve with one needle penetration of the skin

Study type: Interventional

Funder types: Other

Identifiers

NCT01815372

SPEDI

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

SPEDI

Experimental group

Description:

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

Treatment:

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

Popliteal sciatic and mid-femoral saphenous

Active Comparator group

Description:

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

Treatment:

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