The general aim of this present study is to investigate whether blockade of the saphenous nerve can provide the same degree of analgesia postoperatively for ACLS as a femoral nerve block without resulting motor blockade enhancing shortening of…
Source
Brief title
Condition
- Other condition
Synonym
Health condition
postoperative pain
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Readiness to discharge in hours and according to Post-Anesthetic
Discharge Scoring System (PADSS)
Secondary outcome
Degree of motor blockade, patient satisfaction, pain score (VAS) and overall
benefit of analgesia score (OBAS) for the day of surgery and the first
postoperative day.
- IKDC questionnaire
- KOOS questionnaire
- SF-12
- Sensory blockade extent
- Time to rescue analgesic (morphine postoperatively)
- Total analgesic consumption (telephone interview)
- Time to mobilization (telephone interview)
- Knee function will be done by the Knee Society 6 weeks after surgery
- Incidence of falls or near falls
Background summary
Anterior cruciate ligament surgery (ACLS) of the knee is a potentially painful
procedure, which is increasingly performed on an outpatient basis. The
contemporary gold standard for pain treatment is femoral nerve block performed
at the inguinal crease, with subsequent numbing of the entire nerve, including
motor and sensory function. Motor block may, however, may impair early
mobilization and lead to falls. Another possibility is to block only the
saphenous nerve, which contains the femoral nerve*s sensory fibers supplying
the knee joint. In theory, this will provide the same level of analgesia as a
femoral nerve block, but without the accompanying motor weakness.
Study objective
The general aim of this present study is to investigate whether blockade of the
saphenous nerve can provide the same degree of analgesia postoperatively for
ACLS as a femoral nerve block without resulting motor blockade enhancing
shortening of hospital stay en functional outcome.
Study design
Multi-center, prospective, randomized, double-blind clinical trial.
Intervention
Single shot ultrasound-guided mid thigh saphenous nerve blockade for
postoperative pain therapy.
Study burden and risks
No additional burden is expected as clinically used routine pain management
strategies are compared with each other.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Informed consent, age 18-65 years, ASA status I - III, rupture of the anterior cruciate ligament.
Exclusion criteria
Inability to perform written informed consent, contraindication for regional anesthesia, contraindication for general anesthesia, allergy against local anesthetics, BMI > 35, pre-existing diagnosed neuropathy of the operated leg, ingestion of strong opioids, pregnancy or breastfeeding status. History of significant cardiovascular disease (MI, CVA, peripheral vascular disease)
Design
Recruitment
Medical products/devices used
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 |
---|---|
EudraCT | EUCTR2013-003684-54-NL |
CCMO | NL46184.018.13 |