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OpenTrials
Completed

NCT Number: NCT05532618

Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery

The goal of this study is to objectify the postoperative pain level, the use of opiates and postoperative nausea and vomiting after adding the adductor canal block to the standard pain regiment after anterior cruciate ligament surgery

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Key information

Conditions

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

St. Antonius Ziekenhuis

Nieuwegein, 3435CM, Netherlands

About this study

Patients scheduled for anterior cruciate ligament surgery will be randomized in an intervention and control group following informed consent.

Before surgery, patients will receive an adductor canal bock with Levobupivacaine (intervention group) or 0.9% saline (control group).

Following surgery, pain intensity, analgesic consumption and pain satisfaction will be recorded bij patients in a diary for 48 hours.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18 or older
  • Undergoing anterior cruciate ligament surgery under general anesthesia
  • ASA I-III

Exclusion criteria

  • Contraindication for locoregional anesthesia; infection at the target puncture site, allergy to local anesthetics,
  • Neuromuscular disorders

Treatment and study plan

Adductor canal block

Procedure

Before anterior cruciate ligament surgery an adductor canal block will be placed using ultrasound.

Levobupivacaine

Drug

Levobupivacaine

Placebo

Drug

10 ml of sodium chloride 0.9%

Primary outcomes

  1. Postoperative pain level

    Time frame: Within first 48 hours after surgery

    Using Numerical Rating Scales for pain from 1 to 10, 1 is no pain, 10 is the worst pain you can imagine

Secondary outcomes

  1. Opiate use

    Time frame: Within first 48 hours after surgery

    postoperative use of opiates (Morphine equivalent dose (mg))

  2. Nausea

    Time frame: Within first 48 hours after surgery

    Postoperative nausea (yes/no)

  3. Block result

    Time frame: within first 24 hours after surgery

    If there's any loss of motor function (no quadriceps paresis, partial quadriceps paresis, complete quadriceps paresis.) using bromage score

  4. Patient satisfaction

    Time frame: 48 hours after surgery

    Using Numerical Rating Scales from 1 to 10, 1 is not satisfied at all, 10 is completely satisfied

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery: A Prospective Double Blinded Randomized Controlled Trial

Acronym: DUAL

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2022
Registry last updated
Sep 13, 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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