Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Procedure: Adductor canal block; Drug: Levobupivacaine; Drug: Placebo

• Registration Number: NCT05532618
• Lead Sponsor: St. Antonius Hospital

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.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-08
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-09
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levobupivacaine	Adductor canal block	Intervention group; 10 ml of Levobupivacaine 0.25% will be added in the adductor canal using ultrasound
Levobupivacaine	Levobupivacaine	Intervention group; 10 ml of Levobupivacaine 0.25% will be added in the adductor canal using ultrasound
Placebo	Adductor canal block	Control group; 10 ml of sodium chloride 0.9% will be added in the adductor canal using ultrasound
Placebo	Placebo	Control group; 10 ml of sodium chloride 0.9% will be added in the adductor canal using ultrasound

Primary Outcome Measures

Name	Time	Method
Postoperative pain level	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 Outcome Measures

Name	Time	Method
Nausea	Within first 48 hours after surgery	Postoperative nausea (yes/no)
Opiate use	Within first 48 hours after surgery	postoperative use of opiates (Morphine equivalent dose (mg))
Patient satisfaction	48 hours after surgery	Using Numerical Rating Scales from 1 to 10, 1 is not satisfied at all, 10 is completely satisfied
Block result	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

Trial Locations

Locations (1)

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands