Clinical trial NCT01459523: Optimizing Catheter Insertion Technique for Ultrasound-guided Continuous Peripheral Nerve Blocks
Official title: Optimizing Catheter Insertion Technique for Ultrasound-guided Continuous Peripheral Nerve Blocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Peripheral Nerve Block
Perineural Catheter
Orthopedic Surgery
Ultrasound
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
First posted: 2011-10-25
Enrollment: 200
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: Continuous peripheral nerve blocks (CPNB; also known as "perineural" catheters) provide target-specific pain control for a variety of surgeries. There has been increasing interest in the use of ultrasound guidance for regional anesthesia, and many techniques using ultrasound alone for perineural catheter insertion have been described. Catheters may be placed at various points along the brachial plexus (for upper extremity procedures) or in proximity to the femoral and/or sciatic nerve (for lower extremity procedures). To date, the optimal ultrasound scanning technique, catheter insertion endpoint, catheter placement location per indication, for the majority of ultrasound-guided continuous peripheral nerve blocks remain unknown. This study will help provide important information related to optimal ultrasound scanning techniques and will help identify ways to improve the success rates, onset times, and analgesic effectiveness of these techniques for real patients undergoing surgical procedures.

Detailed description: Primary Aim: To determine if there is an optimal scanning technique for ultrasound-guided perineural catheter insertion that will result in the most accurate tip placement in proximity to the target nerve or plexus.

Secondary Aim: To determine if there is an optimal location for ultrasound-guided perineural catheter insertion along a target nerve or plexus that will result in maximum local anesthetic infusion benefits.

Eligibility criteria: Inclusion criteria:

* At least 18 years of age;
* Undergoing unilateral, upper (at or distal to the elbow) or lower (hip or distal) extremity orthopedic surgery, with moderate-to-severe postoperative pain expected; and
* Desiring a continuous perineural catheter for postoperative analgesia.

Exclusion criteria:

* Patients who will have difficulty understanding the study protocol or caring for the infusion pump/catheter system; or
* Patients with any known contraindication to study medications, insulin-dependent diabetes mellitus, neuropathy of any etiology in the affected extremity;
* Patients with a contraindication to regional blockade (eg, clotting deficiency);
* Patients with any known acute or chronic hepatic or renal insufficiency or failure;
* Patients with any additional surgical site outside of the catheter-affected area (eg, iliac crest bone graft in addition to hand surgery);
* Patients with chronic opioid use (defined as daily use for more than 4 weeks prior to surgery) or active illicit substance abuse;
* Patient weighing \< 40 kg;
* Pregnancy;
* Incarceration; or
* Inability to communicate with the investigators and hospital staff.

Primary outcomes:
measure: Onset time of sensory anesthesia
timeFrame: 30 minutes
Secondary outcomes:
measure: Time for placement
timeFrame: 30 minutes
measure: Postoperative pain
timeFrame: 1 day
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health System
state: California
Study officials:
affiliation: VA Palo Alto Health Care System (VAPAHCS)
name: Edward R Mariano, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grant SA, Nielsen KC, Greengrass RA, Steele SM, Klein SM. Continuous peripheral nerve block for ambulatory surgery. Reg Anesth Pain Med. 2001 May-Jun;26(3):209-14. doi: 10.1053/rapm.2001.22256.
citation: Mariano ER, Cheng GS, Choy LP, Loland VJ, Bellars RH, Sandhu NS, Bishop ML, Lee DK, Maldonado RC, Ilfeld BM. Electrical stimulation versus ultrasound guidance for popliteal-sciatic perineural catheter insertion: a randomized controlled trial. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):480-5. doi: 10.1097/AAP.0b013e3181ada57a.
citation: Mariano ER, Loland VJ, Bellars RH, Sandhu NS, Bishop ML, Abrams RA, Meunier MJ, Maldonado RC, Ferguson EJ, Ilfeld BM. Ultrasound guidance versus electrical stimulation for infraclavicular brachial plexus perineural catheter insertion. J Ultrasound Med. 2009 Sep;28(9):1211-8. doi: 10.7863/jum.2009.28.9.1211.
citation: Mariano ER, Loland VJ, Sandhu NS, Bishop ML, Lee DK, Schwartz AK, Girard PJ, Ferguson EJ, Ilfeld BM. Comparative efficacy of ultrasound-guided and stimulating popliteal-sciatic perineural catheters for postoperative analgesia. Can J Anaesth. 2010 Oct;57(10):919-26. doi: 10.1007/s12630-010-9364-7. Epub 2010 Aug 11.