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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Onset Time of Sciatic Nerve Block | Time to onset of sciatic nerve anesthesia, defined as both following criteria:
| ≤30 minutes after block performance |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | ≤30 min after block performance |
| Measure | Description | Time Frame |
|---|---|---|
| Extra- vs. Intraneural Minimum Electrical Stimulation Thresholds | The minimum electrical nerve stimulation threshold will be recorded as a function of needle tip position. | During performance of nerve block (<30 min) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Baciarello, MD | University of Parma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anesthesia, Critical Care and Pain Medicine - University of Parma | Parma | PR | 43126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22005661 | Background | 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. | |
| 22609646 | 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. |
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| 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. |
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| Femoral Nerve Block | Procedure | Patients will receive an ultrasound-guided femoral nerve block using a short- or long-acting local anesthetic, as deemed indicated. |
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| 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. |
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| Ropivacaine | Drug | Thirty milliliters of 0.75% (wt/vol) ropivacaine will be used for the sciatic nerve block. |
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| 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. | 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:
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 |
| 19608846 | 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. |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
| D007869 | Leg Injuries |
| D018409 | Foot Injuries |
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D010323 | Passive Cutaneous Anaphylaxis |
| D000077212 | Ropivacaine |
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D000937 | Antigen-Antibody Reactions |
| D055633 | Immune System Phenomena |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
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