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

NCT01999647 | Completed

• 1 other identifier: ANEST-ORT-04
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Disorders; Foot Diseases; Injuries, Leg; Injuries, Foot; Injuries, Knee

Keywords

Lower Extremity; Sciatic Nerve; Anesthetics, Local; Ropivacaine; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Onset Time of Sciatic Nerve Block

  Time to onset of sciatic nerve anesthesia, defined as both following criteria: * Sensory: does not feel pain or discomfort when pricked with a 25G needle. * Motor: able to slightly curl toes; unable to flex the ankle.

  ≤30 minutes after block performance

Secondary Outcomes (3)

• Success Rate of Sciatic Nerve Blocks

  ≤30 min after block performance

• Incidence and Prevalence of Neurologic Disturbances

  30 days after anesthesia performance

• Differences in Time to Resolution of Sciatic Nerve Block

  <12 h

Other Outcomes (1)

• Extra- vs. Intraneural Minimum Electrical Stimulation Thresholds

  During performance of nerve block (<30 min)

Study Arms (2)

Perineural

ACTIVE COMPARATOR

Patients in this group will receive a perineural injection for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.

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

Intraneural

EXPERIMENTAL

Patients in this group will receive an intraneural injection for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.

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

Interventions

Intraneural Injection for Subgluteal Sciatic Nerve Block PROCEDURE

The injection will start as the needle penetrates the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as "intraneural" if nerve cross section expansion and a reduction in echogenicity are observed. Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach.

Also known as: Injection beneath the common investing extraneural layer, Subepineural Injection, Gluteal sciatic nerve block, Subparaneural injection

Intraneural

Perineural Injection for Subgluteal Sciatic Nerve Block PROCEDURE

The injection will start as the needle indents the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as "intraneural" if the drug infiltrates the space between the epimysium of the surrounding muscles and the outer epineurium of the sciatic nerve. Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach.

Also known as: Injection outside the common investing extraneural layer, Epineural injection, Extraneural injection, Injection outside the paraneurium

Perineural

Femoral Nerve Block PROCEDURE

Patients will receive an ultrasound-guided femoral nerve block using a short- or long-acting local anesthetic, as deemed indicated.

Intraneural; Perineural

Patient-Controlled Postoperative Analgesia PROCEDURE

Patients will receive a patient-controlled intravenous or perineural catheter-based analgesia, depending on their preference and the anesthesiologist's indication.

Also known as: PCA, PCIVA, PCCPNB, Patient-controlled continuous peripheral nerve block

Intraneural; Perineural

Ropivacaine DRUG

Thirty milliliters of 0.75% (wt/vol) ropivacaine will be used for the sciatic nerve block.

Also known as: Local Anesthetic, Naropin, Naropine

Intraneural; Perineural

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

Anesthesia, Critical Care and Pain Medicine - University of Parma

Parma, PR, 43126, Italy

Location

Related Publications (3)

• 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.

  PMID: 22005661 BACKGROUND

• 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.

  PMID: 22609646 BACKGROUND

• 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.

  PMID: 19608846 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases; Foot Diseases; Leg Injuries; Foot Injuries; Knee Injuries

Interventions

Passive Cutaneous Anaphylaxis; Ropivacaine; Anesthetics, Local

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Marco Baciarello, MD

  University of Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, Critical Care and Pain Medicine

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 3, 2013
• Study Start: December 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

IT (1)