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Completed

NCT Number: NCT00497276

Comparison of Ultrasound and Nerve Stimulation Technique for Continuous Sciatic Nerve Block

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Aarhus University Hospital

Aarhus, DK-8000 Aarhus C, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

placement of popliteal catheter

Procedure

Bolus naropin 7,5 mg/ml 30 ml; infusion bupivacaine 2,5 mg/ml 5-10 ml/h

Primary outcomes

  1. Success rate: post-operative analgesia

    Time frame: First two post-operative days

Secondary outcomes

  1. Time consumption of catheter placement

    Time frame: Before surgery

  2. Duration of post-operative observation

    Time frame: After surgery

  3. Pain score

    Time frame: First two post-operative days

  4. Nausea score

    Time frame: First two post-operative days

  5. Sensory block

    Time frame: First two post-operative days

  6. Patient acceptance

    Time frame: First two postoperative days

  7. Cost-effectiveness

    Time frame: Two days

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • National Board of Health, Denmark

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 6, 2007
Registry last updated
Dec 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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