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 channel block to the standard pain regiment after anterior cruciate ligament surgery.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is postoperative pain (numerical rating score) within the
first 24 hours
Secondary outcome
Secondary endpoints are pain score 48 hours postoperative, motor block result,
use of postoperative pain medication including opiates and the use of rescue
medication, postoperative pain location, postoperative nausea and vomiting, use
of anti-emetics, overall patient satisfaction, contact within 48 hours after
surgery with general practicioner or emergency department and adverse events.
Background summary
Addition of locoregional anesthesia to the standard, multimodal pain management
reduces postoperative pain after knee surgery. Locoregional blockade of the
femoral nerve provides adequate pain relief after knee surgery but can induce
weakness of the quadriceps muscle as an adverse event. Blocking the saphenous
nerve, the vastus medialis nerve and the medial femoral cutaneous nerve
ocasionally with the anterior skin branch of the obturator nerve, known as the
*adductor channel* is a simple and effective technique to reduce postoperative
pain after knee surgery.
Study objective
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 channel
block to the standard pain regiment after anterior cruciate ligament surgery.
Study design
Prospective, double blinded randomized intervention study.
Intervention
Identification of the adductor channel using ultrasonic landmarks such as the
femoral artery and the sartorius muscle. When a patient is randomized in the
intervention group; 10 ml of Levobupivacaine 0.25% will be added in the
adductor channel. When randomized in the control group: 10 ml of sodium
chloride 0.9% (placebo) will be added in the adductor channel.
Study burden and risks
Locoregional anesthesia is an existing and well recognized method to relieve
perioperative and postoperative pain. Addition of locoregional anesthesia to
the standard, multimodal pain regimen will reduce postoperative pain and use of
pain medication after knee surgery. Patients will be randomized between the
control group (placebo injection with sodium chloride 0.9% solution) or the
adductor channel block with levobupivacaine 0.25%. After induction, study
patients will either receive a placebo injection of the adductor channel block
or with levobupivacaine. The ultrasonic landmarks (femoral artery and sartorius
muscle) are easily recognizable using ultrasound. The risks of the adductor
channel block are limited and are being minimalized by the use of ultrasound.
Known adverse events are infection, bleeding, intravascular administration and
temporary motor block.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
- ASA classification 1-3
- Age >= 18 years
- Anterior cruciate ligament surgery
- General anesthesia
- Informed consent
Exclusion criteria
- Contraindication to local anesthetics
- Neuromuscular disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80947.100.22 |
| Other | volgt |