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

Primary Purpose

Anterior Cruciate Ligament Injuries

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Adductor canal block
Levobupivacaine
Placebo
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anterior Cruciate Ligament Injuries focused on measuring adductor canal block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Antonius Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Levobupivacaine

Placebo

Arm Description

Intervention group; 10 ml of Levobupivacaine 0.25% will be added in the adductor canal using ultrasound

Control group; 10 ml of sodium chloride 0.9% will be added in the adductor canal using ultrasound

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Opiate use
postoperative use of opiates (Morphine equivalent dose (mg))
Nausea
Postoperative nausea (yes/no)
Block result
If there's any loss of motor function (no quadriceps paresis, partial quadriceps paresis, complete quadriceps paresis.) using bromage score
Patient satisfaction
Using Numerical Rating Scales from 1 to 10, 1 is not satisfied at all, 10 is completely satisfied

Full Information

First Posted
September 2, 2022
Last Updated
September 9, 2023
Sponsor
St. Antonius Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05532618
Brief Title
Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery
Acronym
DUAL
Official Title
Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery: A Prospective Double Blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
Keywords
adductor canal block

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomized to receive an intervention (nerve block) with either an active drug or placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Medication is prepared by study personell not otherwise involved in the study according to a computer generated randomization plan. This plan will be available for analyses after the study. Primary investigator is able to retreive the allocation prematurely if indicated (emergency).
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levobupivacaine
Arm Type
Active Comparator
Arm Description
Intervention group; 10 ml of Levobupivacaine 0.25% will be added in the adductor canal using ultrasound
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control group; 10 ml of sodium chloride 0.9% will be added in the adductor canal using ultrasound
Intervention Type
Procedure
Intervention Name(s)
Adductor canal block
Intervention Description
Before anterior cruciate ligament surgery an adductor canal block will be placed using ultrasound.
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Intervention Description
Levobupivacaine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
10 ml of sodium chloride 0.9%
Primary Outcome Measure Information:
Title
Postoperative pain level
Description
Using Numerical Rating Scales for pain from 1 to 10, 1 is no pain, 10 is the worst pain you can imagine
Time Frame
Within first 48 hours after surgery
Secondary Outcome Measure Information:
Title
Opiate use
Description
postoperative use of opiates (Morphine equivalent dose (mg))
Time Frame
Within first 48 hours after surgery
Title
Nausea
Description
Postoperative nausea (yes/no)
Time Frame
Within first 48 hours after surgery
Title
Block result
Description
If there's any loss of motor function (no quadriceps paresis, partial quadriceps paresis, complete quadriceps paresis.) using bromage score
Time Frame
within first 24 hours after surgery
Title
Patient satisfaction
Description
Using Numerical Rating Scales from 1 to 10, 1 is not satisfied at all, 10 is completely satisfied
Time Frame
48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Timmerman, dr
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435CM
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
23788068
Citation
Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.
Results Reference
background
PubMed Identifier
31980156
Citation
Johnston DF, Sondekoppam RV, Uppal V, Litchfield R, Giffin R, Ganapathy S. Effect of combining peri-hamstring injection or anterior obturator nerve block on the analgesic efficacy of adductor canal block for anterior cruciate ligament reconstruction: a randomised controlled trial. Br J Anaesth. 2020 Mar;124(3):299-307. doi: 10.1016/j.bja.2019.11.032. Epub 2020 Jan 21.
Results Reference
background

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Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery

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