Clinical trial NCT00497276: Comparison of Ultrasound and Nerve Stimulation Technique for Continuous Sciatic Nerve Block
Official title: A Prospective, Randomized Comparison of Ultrasound Versus Nerve Stimulation Guidance of Popliteal, Sciatic Catheter Placement After Major Foot and Ankle Surgery: Clinical Outcome and Cost Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Adults
Anesthesia recovery period
Comparative study
Electric stimulation
Humans
Nerve blocks/methods/indications
Patient satisfaction
Peripheral nerves
Sciatic nerve/ultrasonography
Ultrasonography
Treatment outcome
Nerve blocks/economics
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: National Board of Health, Denmark
First posted: 2007-07-06
Enrollment: 100
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: The most useful method to manage pain after major foot and ankle surgery is infusion of local anesthetic with a catheter close to the sciatic nerve in the popliteal space above the knee joint.

Inaccurate catheter placement and spread of local anesthetic account for most failures.

The most prevalent method to place the catheter is the traditional nerve stimulation technique relying on surface anatomic landmarks and electrical stimulation to localize the sciatic nerve. In recent years ultrasound technique has been applied to provide real-time, visual guidance of catheter placement.

The purpose of this randomized, controlled trial is to compare the success rate, patient acceptance and cost-effectiveness of the ultrasound and nerve stimulation techniques.

Detailed description: Foot and ankle surgery is typically very painful for the first two days postoperatively due to surgical oedema. This pain is difficult to control with systemic analgesics. Pain relief with systemic analgesics requires high doses of intravenous opioids and is associated with breakthrough pain and adverse effects of opioids (sedation, nausea, vomiting, obstipation, urinary retention, mouth dryness, respiratory depression, pruritus, vertigo and visual disturbances).

Single-shot technique provides analgesia for two to 30 hours even using analgesics with prolonged effect (bupivacaine, levobupivacaine, ropivacaine). The duration of the block depends on the local analgesic and the anatomical location. Popliteal block with bupivacaine last up to 24 hours. Continuous, peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics and their adverse effects. Continuous, peripheral nerve block has gained popularity for foot and ankle surgery, because better analgesia is obtained compared to intravenous opioids, and similar analgesia with fewer adverse effects compared to epidural catheter technique.

Today the nerve stimulation technique is the most prevalent technique to introduce catheters for peripheral nerve blocks. The success rate for postoperative analgesia after foot and ankle surgery with popliteal catheters is variable - typically 70% in our department. The patients with catheter failure have severe postoperative pain, high opioid dosages, cognitive blurring, nausea, vomiting, reduced ambulation, increased surgical stress response and increased morbidity. Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge.

Ultrasound technique was employed for peripheral nerve blocks for the first time in 1978. However the utility was technically limited. In recent years, the evolution of high-frequency transducers and mobile ultrasound units have facilitated the application of ultrasound-guided peripheral nerve blocks. This technique allows dynamic visualization of nerves, needle tip location and spread of local analgesic in real-time.

The empirical basis supporting the theoretical advantages of ultrasound-guided regional anesthesia consists mainly of observational studies. A few, randomized, controlled trials comparing ultrasound- and nerve stimulation technique favour the benefit of ultrasound concerning success rate, sensory onset time, duration of block, patient satisfaction and quality of block.

The purpose of this study is to establish whether ultrasound technique has higher success rate, better patient satisfaction and higher cost-effectiveness compared to electrical nerve stimulation using popliteal, sciatic catheters for postoperative analgesia after foot and ankle surgery.

Eligibility criteria: Inclusion Criteria:

elective posterior foot and/or ankle surgery

* calcaneus osteotomy
* subtalar arthrodesis
* total ankle arthroplasty
* ankle arthrodesis (non-arthroscopic) minimum age 18 years ASA I-III informed consent

Exclusion Criteria:

* coagulation disorders
* infection in the region of needle insertion
* systemic infection
* preoperative sciatic nerve neuropathy
* preoperative motor or sensory deficit in the operative extremity
* Charcot-Marie-Tooth disorder
* diabetic neuropathy
* severe peripheral vascular disease
* allergy to local anesthetics
* lack of understanding of the visual analogue scale
* communication problems
* dementia
* body mass index above 35

Primary outcomes:
measure: Success rate: post-operative analgesia
timeFrame: First two post-operative days
Secondary outcomes:
measure: Time consumption of catheter placement
timeFrame: Before surgery
measure: Duration of post-operative observation
timeFrame: After surgery
measure: Pain score
timeFrame: First two post-operative days
measure: Nausea score
timeFrame: First two post-operative days
measure: Sensory block
timeFrame: First two post-operative days
measure: Patient acceptance
timeFrame: First two postoperative days
measure: Cost-effectiveness
timeFrame: Two days
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Anesthesiology, Aarhus University Hospital
Study officials:
affiliation: Department of Anesthesiology, Aarhus University Hospital, Norrebrogade, DK-8000 Aarhus C, Denmark
name: Thomas F Bendtsen, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ehlers L, Jensen JM, Bendtsen TF. Cost-effectiveness of ultrasound vs nerve stimulation guidance for continuous sciatic nerve block. Br J Anaesth. 2012 Nov;109(5):804-8. doi: 10.1093/bja/aes259. Epub 2012 Jul 31.
citation: Bendtsen TF, Nielsen TD, Rohde CV, Kibak K, Linde F. Ultrasound guidance improves a continuous popliteal sciatic nerve block when compared with nerve stimulation. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):181-4. doi: 10.1097/aap.0b013e31820d421f.