The Efficacy of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction

Glostrup University Hospital, Copenhagen50 enrolled

Overview

The Purpose of this study is to determine whether Adductor-Canal-Block is superior to placebo when it comes to analgetic efficacy after reconstruction of the anterior cruciate ligament.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Anterior Cruciate Ligament Reconstruction

Interventions

RopivacainPROCEDURE

Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.

SalinePROCEDURE

Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18-70 years * Reconstruction of Anterior Cruciate Ligament * Written consent * ASA I-II * BMI 19-35 Exclusion Criteria: * Unable to communicate in Danish * Allergic reactions toward drugs used in the trial * Pregnancy * Abuse of alcohol/drugs * Daily opioid intake * Infection at injection site * Can not be mobilised to 5 meters of walk; pre-surgery

Locations (1)

Department of Anaesthesiology, Glostrup University Hospital

Copenhagen, Glostrup, Denmark

Outcomes

Primary Outcomes

Pain-score (VAS), patient standing

Pain-score messured on a Visual Analog Scale (VAS) 2 hours after adductor canal block. Patient standing. Intervention-group vs. placebo-group.

Time frame: 2 hours postoperative

Secondary Outcomes

Total Opioid-consumption

ACB-group vs. placebo-group

Time frame: 0-24 hours postoperative

Postoperative Nausea and Vomiting

Levels of nausea (0-3). ACB-group vs. placebo-group

Time frame: 0 hour postoperative

Postoperative ondansetron consumption

Time frame: In hospital

Pain-score (VAS), patient at rest

ACB-group vs. placebo

Time frame: 0 hours postoperative

Pain-score (VAS), patient at rest

ACB-group vs. placebo

Time frame: 1 hour postoperative

Pain-score (VAS), patient at rest

ACB-group vs. placebo

Time frame: 2 hours postoperative

Pain-score (VAS), patient at rest

ACB-group vs. placebo

Time frame: 4 hours postoperative

Pain-score (VAS), patient at rest

ACB-group vs. placebo

Time frame: 6 hours postoperative

Data from ClinicalTrials.gov

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Pain-score (VAS), patient at rest

ACB-group vs. placebo

Time frame: 8 hours postoperative

Pain-score (VAS), patient at rest

ACB-group vs. placebo

Time frame: 24 hours postoperative

Pain-score (VAS), patient standing

ACB-group vs. placebo

Time frame: 1 hour postoperative

Pain-score (VAS), patient standing

ACB-group vs. placebo

Time frame: 2 hours postoperative

Pain-score (VAS), patient standing

ACB-group vs. placebo

Time frame: 4 hours postoperative

Pain-score (VAS), patient standing

ACB-group vs. placebo

Time frame: 6 hours postoperative

Pain-score (VAS), patient standing

ACB-group vs. placebo

Time frame: 8 hours postoperative

Pain-score (VAS), patient standing

ACB-group vs. placebo

Time frame: 24 hours postoperative

Pain-score (VAS), after 5 meters of walk

ACB-group vs. placebo

Time frame: 2 hours postoperative

Pain-score (VAS), after 5 meters of walk

ACB-group vs. placebo

Time frame: 4 hours postoperative

Pain-score (VAS), after 5 meters of walk

ACB-group vs. placebo

Time frame: 6 hours postoperative

Pain-score (VAS), after 5 meters of walk

ACB-group vs. placebo

Time frame: 8 hours postoperative

Pain-score (VAS), after 5 meters of walk

ACB-group vs. placebo

Time frame: 24 hours postoperative

Postoperative Nausea and Vomiting

Levels of nausea (0-3). ACB-group vs. placebo-group

Time frame: 1 hours postoperative

Postoperative Nausea and Vomiting

Levels of nausea (0-3). ACB-group vs. placebo-group

Time frame: 2 hours postoperative

Postoperative Nausea and Vomiting

Levels of nausea (0-3). ACB-group vs. placebo-group

Time frame: 4 hours postoperative

Postoperative Nausea and Vomiting

Levels of nausea (0-3). ACB-group vs. placebo-group

Time frame: 6 hours postoperative

Postoperative Nausea and Vomiting

Levels of nausea (0-3). ACB-group vs. placebo-group

Time frame: 8 hours postoperative

Postoperative Nausea and Vomiting

Levels of nausea (0-3). ACB-group vs. placebo-group

Time frame: 24 hours postoperative

Sedation

Levels of sedation (0-3). ACB-group vs. placebo

Time frame: 0, hour postoperative

Sedation

Levels of sedation (0-3). ACB-group vs. placebo

Time frame: 1 hour postoperative

Sedation

Levels of sedation (0-3). ACB-group vs. placebo

Time frame: 2 hours postoperative

Sedation

Levels of sedation (0-3). ACB-group vs. placebo

Time frame: 4 hours postoperative

Sedation

Levels of sedation (0-3). ACB-group vs. placebo

Time frame: 6 hours postoperative

Sedation

Levels of sedation (0-3). ACB-group vs. placebo

Time frame: 8 hours postoperative

Sedation

Levels of sedation (0-3). ACB-group vs. placebo

Time frame: 24 hours postoperative

Postoperative Nausea and Vomiting

Levels of nausea (0-3). ACB-group vs. placebo-group

Time frame: 0 hours postoperative

Pain (VAS) at rest, 0-24 hours postoperative (AUC)

Pain-score messured on a Visual Analog Scale (VAS) 0-24 hours after adductor canal block (AUC). Patient at rest. Intervention-group vs. placebo-group.

Time frame: 0-24 h postoperative

Pain (VAS), patient standing, 1-24 hours postoperative (AUC)

Pain-score messured on a Visual Analog Scale (VAS) 1-24 hours after adductor canal block (AUC). Patient standing. Intervention-group vs. placebo-group.

Time frame: 1-24 hours postoperative

Pain (VAS), pain after 5 meters of walk, 2-24 hours postoperative (AUC)

Pain-score messured on a Visual Analog Scale (VAS) 2-24 hours after adductor canal block (AUC). Pain after 5 meters of walk. Intervention-group vs. placebo-group.

Time frame: 2-24 hours postoperative