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Completed

NCT Number: NCT03683342

Comparison of Analgesic Duration of Popliteal Block Versus Ankle Block in Patients Undergoing Forefoot Surgery

Pain after forefoot surgery can be important and regional anesthesia plays a crucial role in post-operative pain control. Several techniques can be used to achieve surgical anesthesia as well as postoperative analgesia. Of those techniques the ankle block and sciatic nerve block at the popliteal fossa are the most common. The primary goal of this study is thus to compare the analgesic duration of these two types of blocks for patients undergoing forefoot surgery.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

Patients scheduled for unilateral forefoot surgery, aged over 18 years old and ASA status I-III without any contra-indications for regional anesthesia will be enrolled.

After a standard randomisation, patients will be allocated in either of two groups : ankle block or sciatic nerve block at the popliteal fossa. In both groups the patients will have a multimodal analgesic regimen followed by a patient-controlled-analgesia (PCA) of morphine.

The primary endpoint is the analgesic duration, defined by the time between the end of the block procedure and the first IV request of morphine from a PCA.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are going to undergo a unilateral forefoot surgery ;
  • ASA I-III ;
  • Aged 18 years or more;
  • Weighing at least 45 kg

Exclusion criteria

  • Patient refusal and/or language/cognitive barrier
  • Pregnancy
  • Contra-indication for regional anesthesia
  • Opiate or alcohol dependency
  • Concomitant oncological disease with chemotherapy
  • Patients suffering from neuropathic pain

Treatment and study plan

Ankle Block

Procedure

Ankle block will be performed prior to surgery under ultrasound guidance

Sciatic Nerve Block

Procedure

Sciatic nerve block will be performed prior to surgery under ultrasound guidance

Primary outcomes

  1. Duration of analgesia

    Time frame: 24 hours after surgery

    Time elapsed between block procedure and first iv request of morphine from PCA

Secondary outcomes

  1. Total opioid consumption at 24h postoperatively

    Time frame: 24 hours after surgery

    Total consumption of morphine from PCA at 24 postoperative hours

  2. Pain score at rest at 4 postoperative hours

    Time frame: 4 hours after surgery

    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

  3. Pain score on movement at 4 postoperative hours

    Time frame: 4 hours after surgery

    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

  4. Pain score at rest at 12 postoperative hours

    Time frame: 12 hours after surgery

    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

  5. Pain score on movement at 12 postoperative hours

    Time frame: 12 hours after surgery

    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

  6. Pain score at rest at 24 postoperative hours

    Time frame: 24 hours after surgery

    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

  7. Pain score on movement at 24 postoperative hours

    Time frame: 24 hours after surgery

    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

  8. Block success rate

    Time frame: 45 minutes after block procedure

    Success of block assessed by pinprick test

  9. Global patient satisfaction 48h after surgery

    Time frame: 48 hours after surgery

    Patient satisfaction score (visual analog scale, 0 = minimum; 10 = maximum)

  10. Complications after block

    Time frame: 48 hours after surgery

    Report of any intravascular injection or any sensory/motor anomalies

  11. Rate of neuropathic pain

    Time frame: 4-6 weeks postoperatively

    Rate of patients describing neuropathic pain 4-6 weeks postoperatively

  12. Rate of paresthesia

    Time frame: Up to 24 hours after block procedure

    Rate of patients complaining of paresthesia

  13. Block procedure time

    Time frame: Up to 10 minutes after ultrasound scanning

    Time from first ultrasound image to needle withdrawal

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 25, 2018
Registry last updated
Aug 3, 2023

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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