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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497276
• Other study ID #: 0-204-03-8/27
• Status: Completed
• Phase: N/A
• First received: July 4, 2007
• Last updated: December 18, 2009
• Start date: August 2007
• Est. completion date: October 2009

Study information

• Verified date: December 2009
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• placement of popliteal catheter
Bolus naropin 7,5 mg/ml 30 ml; infusion bupivacaine 2,5 mg/ml 5-10 ml/h

Locations

Country	Name	City	State
Denmark	Department of Anesthesiology, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	National Board of Health, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate: post-operative analgesia		First two post-operative days	No
Secondary	Time consumption of catheter placement		Before surgery	No
Secondary	Duration of post-operative observation		After surgery	No
Secondary	Pain score		First two post-operative days	No
Secondary	Nausea score		First two post-operative days	No
Secondary	Sensory block		First two post-operative days	No
Secondary	Patient acceptance		First two postoperative days	No
Secondary	Cost-effectiveness		Two days	No