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Completed

NCT Number: NCT02589288

Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus

The aim of this prospective, randomized , blinded study is to compare two different infusion techniques (continuous VS intermittent automatic bolus) to assess the effects of postoperative analgesia after Day-Case anterior cruciate ligament (ACL) reconstruction.

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Key information

Conditions

Injury of Anterior Cruciate Ligament Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto ortopedico Gaetano Pini

Milan, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age above 18 years old
  • American society of anesthesiology (ASA) physical status I-II
  • Signed informed consensus

Exclusion criteria

  • ASA >II
  • Unstable neurological disease
  • Diabetic mellitus (DM) type I-II
  • Allergy to used drugs
  • Opioid chronic treatment
  • Consensus refusal or not valid
  • Anticoagulant therapy
  • Postoperative intensive care required

Treatment and study plan

Continuous Infusion of ropivacaine 0.2%

Procedure

Postoperative continuous infusion of Ropivacaine 0,2% at 6 ml/h and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).

Other names: naropine 0.2%

Automatic Intermittent Bolus of ropivacaine 0.2%

Procedure

Postoperative Automatic Intermittent Bolus of 6 ml Ropivacaine 0,2% every hour and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).

Primary outcomes

  1. NRS Score

    Time frame: 72h postoperative

    Evaluation of numeric rating score (NRS) in patient with automatic intermittent bolus of Ropivacaine 0,2% instead of classic continuous perfusion

Secondary outcomes

  1. Up and Go test

    Time frame: 72h postoperative

    "up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair

  2. Opioids request

    Time frame: 72h postoperative

    Opioids consumption will be recorded throughout 72 postoperative hours

  3. Local anesthetic consumption

    Time frame: 72h postoperative

    Evaluation of local anesthesia consumption every 6h in first 72 postoperative hours.

  4. 10mt walk test

    Time frame: 72h postoperative

    time need to walk 10 meters

Sponsors and collaborators

Lead sponsor

ASST Gaetano Pini-CTO

Other

Registry information

Official study title

Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus For Postoperative Analgesia After Day-Case Anterior Cruciate Ligament Reconstruction

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 28, 2015
Registry last updated
Aug 14, 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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