The general aim of the present study is to test the efficacy of infrapatellar saphenous nerve block as analgesic adjunct in patients undergoing out-patient arthroscopic knee surgery. Our hypothesis is that saphenous nerve block leads to improved…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
postoperative pain
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overall benefit of analgesia score (OBAS) for the day of surgery and the first
postoperative day.
Secondary outcome
VAS score hourly until discharge, and on the morning and evening of the first
postoperative day (telephone interview together with OBAS on first
postoperative day), sensory block extent one hour postoperatively, time to
rescue analgesic (morphine postoperatively), total analgesic consumption, time
to mobilization, time to discharge from day-care center. Functional tests 6
weeks after surgery. Demographic data, surgery and anesthesia data.
Background summary
Arthroscopic surgery of the knee is a potentially painful procedure, which is
increasingly performed on an outpatient basis. Owing to the surgical access
route, block of the saphenous nerve may be well suited to provide postoperative
analgesia in day-care arthroscopic surgery, decreasing analgesic requirements
and hastening discharge.
Study objective
The general aim of the present study is to test the efficacy of infrapatellar
saphenous nerve block as analgesic adjunct in patients undergoing out-patient
arthroscopic knee surgery. Our hypothesis is that saphenous nerve block leads
to improved postoperative pain therapy, and faster discharge from day-care
surgery.
Study design
Randomized, prospective, double-blind clinical trial. All patients will receive
standard anesthesia and analgesia. Patients in the intervention group will
receive additional saphenous nerve block.
Intervention
Single shot ultrasound-guided saphenous nerve block.
Study burden and risks
We propose to perform a single shot nerve block of the purely sensory
end-branch Ramus infrapatellaris of the saphenous nerve under ultrasound
guidance. The risk of this intervention can be described as very low.
Following this, patients will undergo anesthesia and analgesia for arthroscopy
of the knee according to Departmental protocol.
Patients undergoing intervention treatment can expect substantially decreased
pain scores, and less need for pain medication, thereby potentially decreasing
iatrogenic side-effects such as nausea and vomiting. The expected net effect is
a faster recovery, enhanced patient satisfaction, and faster discharge from
day-care surgery.
Meibergdreef 9
1105AZ Amsterdam
NL
Meibergdreef 9
1105AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Age 18-65 years, ASA status I or II.
Exclusion criteria
Moderate or severe heart, lung, liver, kidney, or psychiatric disease, opioid premedication, obstructive sleep apnea, pregnancy or breastfeeding status.
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 | EUCTR2011-004191-11-NL |
CCMO | NL37867.018.11 |