Clinical trial NCT01981291: Duration of Sciatic Nerve Block After Injection of Local Anesthetic In or Around the Nerve
Official title: Duration of Subgluteal Sciatic Nerve Block After Intra- or Perineural Injection of Mepivacaine: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Orthopedic Surgical Procedures
Postoperative Pain
Keywords: Lower Extremity
Sciatic Nerve
Anesthesia, Regional
Anesthetics, Local
Mepivacaine
Ultrasonography
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Differences in Time to Resolution of Sciatic Nerve Block
timeFrame: <12 h
Secondary outcomes:
measure: Block Onset Time
timeFrame: ≤30 min
measure: Success Rate of Anesthetic Nerve Blocks
timeFrame: ≤30 min
measure: Incidence and Prevalence of Neurologic Disturbances
timeFrame: 30 days
Other outcomes:
measure: Extra- vs. Intraneural Minimum Electrical Stimulation Thresholds
timeFrame: (during the procedure)
Locations:
city: Parma
country: Italy
facility: Anesthesia, Critical Care and Pain Medicine - University of Parma
state: PR
Study officials:
affiliation: University of Parma
name: Marco Baciarello, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.