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OpenTrials
Completed

NCT Number: NCT05728294

Femoral or Sciatic Nerve Block to Provide Analgesia After Proximal Tibial Osteotomy

Proximal tibial osteotomy is associated with moderate to severe postoperative pain. The proximal part of the tibia is innervated by branches from the femoral nerve anteriorly and the sciatic nerve posteriorly. Little is known on the type of peripheral nerve block to perform so that optimal postoperative analgesia is provided with minimum impact on the motor function. This randomised controlled double-blinded trial tested the hypothesis that a femoral nerve block provides superior analgesia than a sciatic nerve block after proximal tibial osteotomy.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • proximal tibial osteotomy

Exclusion criteria

  • femoral or sciatic nerve deficit,
  • pre-existing peripheral neuropathy,
  • chronic pain diagnosis,
  • pregnancy,
  • identified contraindications to peripheral nerve block (e.g., local anesthetic allergy, coagulopathy, or infection at the block site).

Treatment and study plan

Femoral nerve block with ropivacaine 0.5%, 20 ml

Procedure

Femoral nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml

Sciatic nerve block with ropivacaine 0.5%, 20 ml

Procedure

Sciatic nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml

Primary outcomes

  1. Intravenous morphine consumption

    Time frame: 24 hours after surgery

    Intravenous morphine consumption (mg)

Secondary outcomes

  1. Intravenous morphine consumption

    Time frame: 2 hours after surgery

    Intravenous morphine consumption (mg)

  2. Intravenous morphine consumption

    Time frame: 48 hours after surgery

    Intravenous morphine consumption (mg)

  3. rest pain score

    Time frame: 2 hours after surgery

    pain score at rest (visual analogue scale, 0-10)

  4. rest pain score

    Time frame: 24 hours after surgery

    pain score at rest (visual analogue scale, 0-10)

  5. rest pain score

    Time frame: 48 hours after surgery

    pain score at rest (visual analogue scale, 0-10)

  6. dynamic pain score

    Time frame: 2 hours after surgery

    pain score on movement (visual analogue scale, 0-10)

  7. dynamic pain score

    Time frame: 24 hours after surgery

    pain score on movement (visual analogue scale, 0-10)

  8. dynamic pain score

    Time frame: 48 hours after surgery

    pain score on movement (visual analogue scale, 0-10)

  9. Rate of postoperative nausea and vomiting

    Time frame: 2 hours after surgery

    number of events/total number of patients

  10. Rate of postoperative nausea and vomiting

    Time frame: 24 hours after surgery

    number of events/total number of patients

  11. Rate of postoperative nausea and vomiting

    Time frame: 48 hours after surgery

    number of events/total number of patients

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Feb 15, 2023
Registry last updated
Apr 21, 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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