Anterior Cruciate Ligament Injuries
Conditions
Keywords
adductor canal block
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.
Interventions
PROCEDUREAdductor canal block
Before anterior cruciate ligament surgery an adductor canal block will be placed using ultrasound.
DRUGLevobupivacaine
Levobupivacaine
DRUGPlacebo
10 ml of sodium chloride 0.9%
Sponsors
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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).
Intervention model description
Patients are randomized to receive an intervention (nerve block) with either an active drug or placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Opiate use | Within first 48 hours after surgery | postoperative use of opiates (Morphine equivalent dose (mg)) |
| Nausea | Within first 48 hours after surgery | Postoperative nausea (yes/no) |
| 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 |
| Patient satisfaction | 48 hours after surgery | Using Numerical Rating Scales from 1 to 10, 1 is not satisfied at all, 10 is completely satisfied |
Countries
Netherlands
Outcome results
None listed