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Completed

NCT Number: NCT02465827

Ultrasound-guided Selective Blockade of the Saphenous and Obturator Nerves Following Total Knee Arthroplasty

The investigators aimed to evaluate the efficacy of selective low volume ultrasound-guided blockades of the saphenous and obturator nerves on dynamic and rest pain 24-hours post-operatively for patients undergoing unilateral primary total knee arthroplasty.

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Key information

Conditions

Knee Arthroplasty, Total

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

A femoral nerve block is the recommended strategy in many surgical centers to supplement multimodal analgesic regime following total knee arthroplasty (TKA) (i.e. both for spinal and general anesthesia). However, a femoral nerve block will often result in quadriceps paralysis, and this will increase the risk for the patient to fall as long as the femoral block have effect. Thus, the search for sensory nerve blocks to stop pain after TKA is a very interesting topic. The saphenous nerve is a purely sensory nerve, and the posterior branch of the obturator nerve is a mixed nerve, where the motor component only affects part of the adductor major muscle.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists' physical classification I-III
  • Age ≥ 18 years undergoing primary unilateral total knee arthroplasty

Exclusion criteria

  • Inability to cooperate
  • Inability to speak and understand Danish
  • Allergy to any drugs used in the study
  • Drug or alcohol abuse
  • Pregnancy or nursing
  • Opioid abusers

Treatment and study plan

nerve block with ropivacaine

Drug

Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with ropivacaine 0.75% for both nerve branches

Other names: Saphenous and obturator nerve block with ropivacaine

nerve block with ropivacaine and with saline

Drug

nerve blocks of the saphenous nerve with ropivacaine 0.75% and obturator nerve, posterior branch with saline

Other names: Saph block with ropivacaine and obtur block with saline

nerve block with saline

Drug

Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with saline for both nerve branches

Other names: saphenous and obturator nerve block with saline

Primary outcomes

  1. Dynamic pain (pain upon movement) quantified as area-under-the-curve (AUC) 24-hours post-operatively

    Time frame: 24 hours

    NRS 0-10

Secondary outcomes

  1. Pain at rest quantified as area-under-the-curve (AUC) 24-hours post-operatively

    Time frame: 24 hours

    NRS 0-10

  2. Total opioid consumption

    Time frame: 24 hours

    mg

  3. Nausea and vomiting

    Time frame: 24 hours

    NRS 0-10

  4. Time to first mobilization

    Time frame: 24 hours

    hours

  5. Length of stay in recovery and hospital

    Time frame: 72 hours

    hours

  6. Number of clinical complications

    Time frame: 72 hours

    total number

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

Selective Blocks for Total Knee Arthroplasty

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2015
Registry last updated
Jun 9, 2015

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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