Lower Leg Surgery, e.g. Ankle Fractures Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | June 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Bispebjerg Hospital | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| Bispebjerg Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Opioid consumption (micrograms of sufentanil) in total in the recovery unit. | Normally from 0 hours until 2 hours after arrival in the recovery unit. | No | |
| Primary | 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. | The time measurement is done with a normal clock - measuring seconds and minutes. | 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. | No |
| Secondary | Pain score (VAS score 0-10). | 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. | No | |
| Secondary | Sensory dermatome testing. | 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. | Normally until 2 hours postoperatively. | No |