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Efficacy of Ultrasound-Guided Local Anesthetic Injection Into or Around the Sciatic Nerve for Lower Limb Anesthesia

Information source: University of Parma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Orthopedic Disorders; Foot Diseases; Injuries, Leg; Injuries, Foot; Injuries, Knee

Intervention: Intraneural Injection for Subgluteal Sciatic Nerve Block (Procedure); Perineural Injection for Subgluteal Sciatic Nerve Block (Procedure); Femoral Nerve Block (Procedure); Patient-Controlled Postoperative Analgesia (Procedure); Ropivacaine (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Parma

Official(s) and/or principal investigator(s):
Marco Baciarello, MD, Principal Investigator, Affiliation: University of Parma

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.

Clinical Details

Official title: Intraneural Injection of Ropivacaine for Subgluteal Sciatic Nerve Block Leads to Faster Onset and Higher Success Rates: a Randomized, Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Onset Time of Sciatic Nerve Block

Secondary outcome:

Success Rate of Sciatic Nerve Blocks

Incidence and Prevalence of Neurologic Disturbances

Differences in Time to Resolution of Sciatic Nerve Block

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Anesthesia, Critical Care and Pain Medicine — University of Parma, Parma, PR 43126, Italy
Additional Information

Related publications:

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.

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.

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.

Starting date: December 2011
Last updated: December 2, 2013

Page last updated: August 23, 2015

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