Duration of Subgluteal Sciatic Nerve Block After Intra- or Perineural Injection of Mepivacaine: a Randomized, Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Perineural Injection for Subgluteal Sciatic Nerve Block
- Conditions
- Orthopedic Surgical Procedures
- Sponsor
- University of Parma
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Differences in Time to Resolution of Sciatic Nerve Block
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Detailed Description
This randomized, controlled trial will investigate prospectively for differences in sensory and motor block duration after intra- or perineural injection of 1.5% (wt/vol) mepivacaine, a short-acting local anesthetic.
Investigators
Marco Baciarello
Assistant Professor, Anesthesia, Critical Care and Pain Medicine
University of Parma
Eligibility 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 signs of neuropathy in the ipsilateral extremity
- •Inability to satisfactorily image the sciatic nerve in the opinion of the attending anesthesiologist
Arms & Interventions
Perineural
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.
Intervention: Perineural Injection for Subgluteal Sciatic Nerve Block
Perineural
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.
Intervention: Femoral Nerve Block
Perineural
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.
Intervention: Patient-controlled postoperative analgesia
Perineural
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.
Intervention: Mepivacaine
Intraneural
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.
Intervention: Intraneural Injection for Subgluteal Sciatic Nerve Block
Intraneural
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.
Intervention: Femoral Nerve Block
Intraneural
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.
Intervention: Patient-controlled postoperative analgesia
Intraneural
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.
Intervention: Mepivacaine
Outcomes
Primary Outcomes
Differences in Time to Resolution of Sciatic Nerve Block
Time Frame: <12 h
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.
Secondary Outcomes
- Success Rate of Anesthetic Nerve Blocks(≤30 min)
- Incidence and Prevalence of Neurologic Disturbances(30 days)
- Block Onset Time(≤30 min)