Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery

NCT ID: NCT05532618

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-08-01

Brief Summary

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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

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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.

Conditions

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Anterior Cruciate Ligament Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are randomized to receive an intervention (nerve block) with either an active drug or placebo.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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).

Study Groups

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Levobupivacaine

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

Group Type ACTIVE_COMPARATOR

Adductor canal block

Intervention Type PROCEDURE

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

Levobupivacaine

Intervention Type DRUG

Levobupivacaine

Placebo

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

Group Type PLACEBO_COMPARATOR

Adductor canal block

Intervention Type PROCEDURE

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

Placebo

Intervention Type DRUG

10 ml of sodium chloride 0.9%

Interventions

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Adductor canal block

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

Intervention Type PROCEDURE

Levobupivacaine

Levobupivacaine

Intervention Type DRUG

Placebo

10 ml of sodium chloride 0.9%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

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Leon Timmerman

M.D., PhD, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leon Timmerman, dr

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

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St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 23788068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31980156 (View on PubMed)

Other Identifiers

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NL 81489.100.22

Identifier Type: -

Identifier Source: org_study_id

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