Clinical trial NCT01837394: Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy
Official title: Ultrasound-guided Block of the Saphenous Nerve and Obturator Nerve, Posterior Branch, for Postoperative Pain Management After Ambulatory Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Postoperative Nausea and Vomiting
Postoperative Function Level
Keywords: Nerve block
Ultrasound
postoperative pain
Saphenous nerve
Obturator nerve
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we wish to investigate the effect of ultrasound (US) -guided block of the saphenous nerve (SN) and the posterior branch of the obturator nerve (ONP) on postoperative pain and the use of opioids (morphine-like pain medicine) in the first 24 hours following ambulatory knee arthroscopy.

We wish to investigate the analgesic effect of these two blocks compared to placebo (injection of local anesthetic with known pain blocking properties compared with injection of a saline solution), when used as a supplement to conventional oral analgesics.

We hypothesize that patients receiving the active treatment may experience less pain during the first 24 hours after their operation than patients receiving the placebo treatment, and possibly require less opioid analgesics, experience less opioid related side effects and have a higher function level in this period than patients receiving the placebo treatment.


Eligibility criteria: Inclusion Criteria:

* Planned ambulatory knee arthroscopy, except cruciate ligament surgery
* American Society of Anesthesiologists (ASA) class 1-3

Exclusion Criteria:

* Cannot cooperate
* Do not speak or understand Danish
* Daily use of opioid analgesics
* Allergy towards any of the drugs used in the investigation
* Medicine abuse (at the investigators discretion)
* Alcohol abuse, as defined by the National Board of Health
* General anesthesia contraindicated, or the patient wants spinal anesthesia
* Visualization of necessary structures by ultrasound not possible, or block not possible for other technical reasons

Primary outcomes:
measure: Pain on knee flexion
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Pain at rest
timeFrame: 24 hours postoperatively
measure: Time to opioid intake
timeFrame: 24 hours postoperatively
measure: Total opioid intake
timeFrame: 24 hours
measure: Nausea
timeFrame: 24 hours postoperatively
measure: Vomiting
timeFrame: 24 hours
measure: Use of antiemetics
timeFrame: 24 hours
measure: PACU length of stay
timeFrame: 24 hours
measure: Function level: Barthel Index/100
timeFrame: 24 hours
measure: Function level: Short form (SF) -8
timeFrame: 24 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anesthesiology, Bispebjerg Hospital
Study officials:
affiliation: Department of Anesthesiology, Bispebjerg Hospital
name: Bo Westergaard, MD
role: PRINCIPAL_INVESTIGATOR
References: