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NCT Number: NCT02697955

The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery

The study investigates the effect of a ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.

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Key information

Conditions

Arthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

Major ankle and hind foot surgery causes intense postoperative pain. Implementation of continuous sciatic catheters has been a great success in reducing postoperative pain following these operations, but despite an effective sciatic catheter patients still report moderate to severe pain from the anteromedial side of the ankle. According to cadaver dissection studies the saphenous nerve innervates the anterior and medial parts of the ankle and talonavicular joint, and even though a saphenous block is standard procedure in many departments of anesthesiology worldwide, scientific evidence regarding the effect of the saphenous block on postoperative pain is lacking.

This study investigates the effect of a selective, ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective ankle or hind foot surgery either: (1) total ankle arthroplasty, (2) ankle arthrodesis (3) subtalar arthrodesis or (4) triple arthrodesis
  • Age ≥ 18
  • American Society of Anaesthesiology Classification I-III
  • Informed consent both orally and in writing after the patient has fully understood the protocol and its limitations.

Exclusion criteria

  • Communication problems or dementia
  • Allergies to any medical product used in the study
  • Neuropathy of the sciatic or femoral nerve prior to the operation
  • Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral vascular disease
  • Daily use of opioids
  • Coagulation disorders
  • Infection at the site of injection or systemic infection

Treatment and study plan

Bupivacaine-epinephrine

Drug

50 mg bupivacaine and 50 μg adrenalin

Other names: Marcain-adrenalin (combination drug), Marketing Authorisation Holder: AstraZeneca, Marketing Authorisation number: 10213

Placebo

Other

9 mg sodium chloride pr. ml (0,9 %)

Other names: Sodium chloride solution

Primary outcomes

  1. Frequency of patients who experience significant pain at rest (change from no significant pain to significant pain)

    Time frame: Arrival at the Perioperative Section (within 30 minutes after surgery) and at t = 30 min, t = 45 min, t = 60 min, t = 75 min, t = 90 min, t = 105 min, t = 120. The beginning of the observation period (t0) is the registered time for the end of surgery.

    Pain scores evaluated using NRS (numeric rating scale). Significant pain is defined as NRS > 3 from the anterior and/medial side of the ankle joint. In case of significant pain, patients receive a rescue saphenous block with 10 ml bupivacaine-adrenaline.

Secondary outcomes

  1. Sensory testing, infrapatellar branch (nociception is tested using a standardized Neuropen)

    Time frame: At the time point when the patients report a change to significant pain during the observation period. In case of no significant pain during the observation period, sensory testing is conducted at t = 120 min.

    Test of nociceptive response in the cutaneous innervation area of the infrapatellar branch (branch of the saphenous nerve). The test is performed in an area from the medial femoral condyle to the midline between the apex of patella and tibial tuberosity.

  2. Sensory testing, sciatic nerve (nociception is tested using a standardized Neuropen)

    Time frame: Sensory test is conducted at arrival at the Perioperative Section (within 30 minutes after surgery)

    Test of nociceptive response in the sciatic cutaneous innervation area to confirm full sensory block of the sciatic nerve.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2016
Registry last updated
Mar 27, 2017

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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