Clinical trial NCT01815372: Ultrasound-guided Nerve Blocks for the Sciatic and Saphenous Nerves: Characteristics of the Single Penetration Dual Injection (SPEDI) Technique
Official title: Ultrasound-guided Nerve Blocks for the Sciatic and Saphenous Nerves: Characteristics of the Single Penetration Dual Injection (SPEDI) Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Leg Surgery, e.g. Ankle Fractures
Keywords: nerve blocks
ultrasound-guided
leg surgery
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 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.
Secondary outcomes:
measure: Pain score (VAS score 0-10).
timeFrame: 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.
measure: Sensory dermatome testing.
timeFrame: Normally until 2 hours postoperatively.
Other outcomes:
measure: Opioid consumption (micrograms of sufentanil) in total in the recovery unit.
timeFrame: Normally from 0 hours until 2 hours after arrival in the recovery unit.
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
References: