Clinical trial NCT01999647: Efficacy of Ultrasound-Guided Local Anesthetic Injection Into or Around the Sciatic Nerve for Lower Limb Anesthesia
Official title: Intraneural Injection of Ropivacaine for Subgluteal Sciatic Nerve Block Leads to Faster Onset and Higher Success Rates: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorders
Foot Diseases
Injuries, Leg
Injuries, Foot
Injuries, Knee
Keywords: Lower Extremity
Sciatic Nerve
Anesthetics, Local
Ropivacaine
Ultrasonography
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 64
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: This study was designed to assess whether the injection of local anesthetic into the nerve (intraneural), as opposed to around it (perineural), requires a shorter time to develop surgical anesthesia of the lower leg.

The investigators will compare the two types of injection using the same drug, so as to determine if there is an actual difference onset time. They will also examine the overall success rate of either kind of sciatic nerve blocks as the sole anesthetic for non-emergent orthopedic surgery.

The safety of these procedures will be examined by in-hospital and phone-call follow-up contacts.

Detailed description: This will be a randomized, controlled, patient- and observer-blinded trial assessing block characteristics after intra- or perineural injection of ropivacaine for subgluteal sciatic nerve blocks performed for elective surgery of the lower limb.

Eligibility criteria: Inclusion Criteria:

* Undergoing non-emergent orthopedic procedure of knee, leg, foot with thigh tourniquet
* ASA Physical Status Class I-III
* Consenting to surgery under peripheral nerve block anesthesia (sciatic + femoral/saphenous block)

Exclusion Criteria:

* Unable to understand or communicate for the purpose of the study
* Exhibiting any neurological disturbance of the ipsilateral lower extremity
* Inability to satisfactorily image the sciatic nerve in the opinion of the attending anesthesiologist

Primary outcomes:
measure: Onset Time of Sciatic Nerve Block
timeFrame: ≤30 minutes after block performance
Secondary outcomes:
measure: Success Rate of Sciatic Nerve Blocks
timeFrame: ≤30 min after block performance
measure: Incidence and Prevalence of Neurologic Disturbances
timeFrame: 30 days after anesthesia performance
measure: Differences in Time to Resolution of Sciatic Nerve Block
timeFrame: <12 h
Other outcomes:
measure: Extra- vs. Intraneural Minimum Electrical Stimulation Thresholds
timeFrame: During performance of nerve block (<30 min)
Locations:
city: Parma
country: Italy
facility: Anesthesia, Critical Care and Pain Medicine - University of Parma
state: PR
Study officials:
affiliation: University of Parma
name: Marco Baciarello, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tran DQ, Dugani S, Pham K, Al-Shaafi A, Finlayson RJ. A randomized comparison between subepineural and conventional ultrasound-guided popliteal sciatic nerve block. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):548-52. doi: 10.1097/AAP.0b013e318235f566.
citation: Andersen HL, Andersen SL, Tranum-Jensen J. Injection inside the paraneural sheath of the sciatic nerve: direct comparison among ultrasound imaging, macroscopic anatomy, and histologic analysis. Reg Anesth Pain Med. 2012 Jul-Aug;37(4):410-4. doi: 10.1097/AAP.0b013e31825145f3.
citation: Robards C, Hadzic A, Somasundaram L, Iwata T, Gadsden J, Xu D, Sala-Blanch X. Intraneural injection with low-current stimulation during popliteal sciatic nerve block. Anesth Analg. 2009 Aug;109(2):673-7. doi: 10.1213/ane.0b013e3181aa2d73.