Duration of Sciatic Nerve Block After Injection of Local Anesthetic In or Around the Nerve

NCT01981291 | Completed Phase 4

• 1 other identifier: ANEST-ORT-03
• Study Type: interventional
• Target: 120
• 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), leads to longer anesthesia and analgesia of the leg. Some reports of accidental intraneural injection mention an extremely long duration. When different drugs and doses were evaluated in a clinical trial of intraneural injection, a longer-than-expected duration was reported. The investigators will compare the two types of injection using the same drug, so as to determine if there is an actual difference in duration.

Conditions

Orthopedic Surgical Procedures; Postoperative Pain

Keywords

Lower Extremity; Sciatic Nerve; Anesthesia, Regional; Anesthetics, Local; Mepivacaine; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Differences in Time to Resolution of Sciatic Nerve Block

  The time at which sensory and motor function of the sciatic nerve have recovered at least to the following criteria: * Sensory: patients feel discomfort when pricked with a thin needle (25G) * Motor: patients may move both toes and ankle, albeit with reduced strength This outcome measure will be examined by an investigator every 30-60 min and reported by patients as "time to return of sensation and movement". The investigator-reported value will be preferred if both are available.

  <12 h

Secondary Outcomes (3)

• Block Onset Time

  ≤30 min

• Success Rate of Anesthetic Nerve Blocks

  ≤30 min

• Incidence and Prevalence of Neurologic Disturbances

  30 days

Other Outcomes (1)

• Extra- vs. Intraneural Minimum Electrical Stimulation Thresholds

  (during the procedure)

Study Arms (2)

Perineural

ACTIVE COMPARATOR

Patients in this group will receive a perineural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia.

Procedure: Perineural Injection for Subgluteal Sciatic Nerve Block; Procedure: Femoral Nerve Block; Procedure: Patient-controlled postoperative analgesia; Drug: Mepivacaine

Intraneural

EXPERIMENTAL

Patients in this group will receive an intraneural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia.

Procedure: Intraneural Injection for Subgluteal Sciatic Nerve Block; Procedure: Femoral Nerve Block; Procedure: Patient-controlled postoperative analgesia; Drug: Mepivacaine

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 external 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 external layer, Epineural injection, Extraneural injection

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

Mepivacaine DRUG

Thirty milliliters of 1.5% (wt/vol) mepivacaine will be used for the sciatic nerve block.

Also known as: Local Anesthetic, Carbocaine

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 signs of neuropathy in the ipsilateral 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 (2)

• Benhamou D, Blonski E, Levy P, Plessis E, Chalhoub V. Ultra-long duration of a peripheral nerve block: a possible consequence of intraneural (subepineural) local anaesthetic injection. Ann Fr Anesth Reanim. 2010 Jul-Aug;29(7-8):589-91. doi: 10.1016/j.annfar.2010.05.032. Epub 2010 Jul 13.

  PMID: 20630694 BACKGROUND

• Nader A, Kendall MC, De Oliveira GS Jr, Puri L, Tureanu L, Brodskaia A, Asher Y, Parimi V, McCarthy RJ. A dose-ranging study of 0.5% bupivacaine or ropivacaine on the success and duration of the ultrasound-guided, nerve-stimulator-assisted sciatic nerve block: a double-blind, randomized clinical trial. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):492-502. doi: 10.1097/AAP.0b013e3182a4bddf.

  PMID: 24108248 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Passive Cutaneous Anaphylaxis; Mepivacaine; Anesthetics, Local

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

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; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 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: phase 4
• 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, Anesthesia, Critical Care and Pain Medicine

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: October 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

IT (1)