Intraneural Injection of Ropivacaine for Subgluteal Sciatic Nerve Block Leads to Faster Onset and Higher Success Rates: a Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Perineural Injection for Subgluteal Sciatic Nerve Block
- Conditions
- Orthopedic Disorders
- Sponsor
- University of Parma
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Onset Time 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), 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.
Detailed Description
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.
Investigators
Marco Baciarello
Assistant Professor of Anesthesiology, 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 any neurological disturbance of the ipsilateral lower 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 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.
Intervention: Perineural Injection for Subgluteal Sciatic Nerve Block
Perineural
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.
Intervention: Femoral Nerve Block
Perineural
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.
Intervention: Patient-Controlled Postoperative Analgesia
Perineural
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.
Intervention: Ropivacaine
Intraneural
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.
Intervention: Intraneural Injection for Subgluteal Sciatic Nerve Block
Intraneural
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.
Intervention: Femoral Nerve Block
Intraneural
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.
Intervention: Patient-Controlled Postoperative Analgesia
Intraneural
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.
Intervention: Ropivacaine
Outcomes
Primary Outcomes
Onset Time of Sciatic Nerve Block
Time Frame: ≤30 minutes after block performance
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.
Secondary Outcomes
- 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)