An interventional study of Intraneural Injection for Subgluteal Sciatic Nerve Block and Perineural Injection for Subgluteal Sciatic Nerve Block in Orthopedic Disorders, Foot Diseases and Injuries, Leg, sponsored by University of Parma. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-04.
Sponsored by University of Parma · Not applicable, Interventional, and Treatment
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.
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.
657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.
This study's enrollment of 64 is below the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.
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Exclusion Criteria:
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
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
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
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
Patients will receive an ultrasound-guided femoral nerve block using a short- or long-acting local anesthetic, as deemed indicated.
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
Thirty milliliters of 0.75% (wt/vol) ropivacaine will be used for the sciatic nerve block.
Also known as: Local Anesthetic, Naropin, Naropine
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.
Time frame: ≤30 minutes after block performance
Success Rate of Sciatic Nerve Blocks
The percentage of patients who attain the criteria for block success within 30 minutes of the injection. Investigators will also report the percentage of patients who successfully complete surgery without significant additional analgesia (see below); this will be defined as "clinical success rate."
Time frame: ≤30 min after block performance
Incidence and Prevalence of Neurologic Disturbances
Patients will be interviewed at \~4 h (block resolution visit), 7 days and (if necessary) at 30 days to assess for residual neurologic disturbances in the sciatic nerve territory. The incidence/prevalence of these phenomena will be noted.
Time frame: 30 days after anesthesia performance
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.
Time frame: <12 h
Extra- vs. Intraneural Minimum Electrical Stimulation Thresholds
The minimum electrical nerve stimulation threshold will be recorded as a function of needle tip position.
Time frame: During performance of nerve block (<30 min)
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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