Postoperative Function Level, Postoperative Nausea and Vomiting, Postoperative Pain
Conditions
Keywords
Nerve block, Ultrasound, postoperative pain, Saphenous nerve, Obturator nerve
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.
Interventions
PROCEDUREBlock of the SN and ONP
7.5 ml of Ropivacaine 7.5 mg/ml injected at each site
PROCEDUREPlacebo block
7.5 ml of isotonic saline solution 154 mmol/l injected at each site
DRUGParacetamol
DRUGMorphine
5 mg as needed
DRUGOndansetron
4 mg i.v. as needed in the PACU
DRUGMetoclopramide
10 mg tablet as needed in the postoperative period after discharge from the PACU
Sponsors
Jens Borglum Neimann
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain on knee flexion | 24 hours postoperatively | VRS (Verbal Rating Scale) score 0-10 on active flexion of the knee to 45 degrees, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to opioid intake | 24 hours postoperatively | First time the patient needs to take supplementary opioids in the postoperative period |
| Total opioid intake | 24 hours | Total dose of opioids taken in the first 24 hours postoperatively |
| Nausea | 24 hours postoperatively | VRS score 0-10, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis. |
| Vomiting | 24 hours | Number of times the patient has vomited in the first 24 hours postoperatively. |
| Pain at rest | 24 hours postoperatively | VRS (verbal rating score) 0-10 at rest, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis. |
| PACU length of stay | 24 hours | Total length of stay in the post anesthetic care unit (PACU) after the operation. |
| Function level: Barthel Index/100 | 24 hours | Modified Barthel Index/100 score 24 hours after the operation. |
| Function level: Short form (SF) -8 | 24 hours | Short form (SF) -8 questionnaire 24 hours postoperatively |
| Use of antiemetics | 24 hours | Total dose of antiemetics taken during the first 24 hours postoperatively |
Countries
Denmark
Outcome results
None listed