Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery (DUAL)

September 9, 2023 updated by: Leon Timmerman, St. Antonius Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nieuwegein, Netherlands, 3435CM
        • St. Antonius Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Levobupivacaine
Intervention group; 10 ml of Levobupivacaine 0.25% will be added in the adductor canal using ultrasound
Drug: Levobupivacaine
Levobupivacaine
Procedure: Adductor canal block
Before anterior cruciate ligament surgery an adductor canal block will be placed using ultrasound.
Placebo Comparator: Placebo
Control group; 10 ml of sodium chloride 0.9% will be added in the adductor canal using ultrasound
Procedure: Adductor canal block
Before anterior cruciate ligament surgery an adductor canal block will be placed using ultrasound.
Drug: Placebo
10 ml of sodium chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within first 48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opiate use
Time Frame: Within first 48 hours after surgery
postoperative use of opiates (Morphine equivalent dose (mg))
Within first 48 hours after surgery
Nausea
Time Frame: Within first 48 hours after surgery
Postoperative nausea (yes/no)
Within first 48 hours after surgery
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
within first 24 hours after surgery
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
48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Investigators

  • Principal Investigator: Leon Timmerman, dr, St. Antonius Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 9, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL 81489.100.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Following publication of the results, anonymized IPD (all study results) will be available for meta-analyses upon request.

IPD Sharing Time Frame

Following publication of the results, for at least 15 years.

IPD Sharing Access Criteria

Data will be available on request. If a journal allows online sharing of IPD with a publication, this will be considered as well.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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