Anterior Cruciate Ligament Reconstruction
Conditions
Keywords
Adductor Canal Block (ACB), Anterior Cruciate Ligament (ACL) Reconstruction, Saphenous nerve, Pain, Ultrasound block
Brief summary
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.
Interventions
PROCEDURERopivacain
Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.
PROCEDURESaline
Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.
Sponsors
Glostrup University Hospital, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain-score (VAS), patient standing | 2 hours postoperative | Pain-score messured on a Visual Analog Scale (VAS) 2 hours after adductor canal block. Patient standing. Intervention-group vs. placebo-group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain (VAS), pain after 5 meters of walk, 2-24 hours postoperative (AUC) | 2-24 hours postoperative | 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. |
| Total Opioid-consumption | 0-24 hours postoperative | ACB-group vs. placebo-group |
| Postoperative Nausea and Vomiting | 0 hour postoperative | Levels of nausea (0-3). ACB-group vs. placebo-group |
| Postoperative ondansetron consumption | In hospital | — |
| Pain (VAS), patient standing, 1-24 hours postoperative (AUC) | 1-24 hours postoperative | Pain-score messured on a Visual Analog Scale (VAS) 1-24 hours after adductor canal block (AUC). Patient standing. Intervention-group vs. placebo-group. |
| Pain-score (VAS), patient standing | 1 hour postoperative | ACB-group vs. placebo |
| Pain-score (VAS), after 5 meters of walk | 2 hours postoperative | ACB-group vs. placebo |
| Sedation | 0, hour postoperative | Levels of sedation (0-3). ACB-group vs. placebo |
| Pain (VAS) at rest, 0-24 hours postoperative (AUC) | 0-24 h postoperative | 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. |
| Pain-score (VAS), patient at rest | 0 hours postoperative | ACB-group vs. placebo |
Countries
Denmark
Outcome results
None listed