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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Block arm | Active Comparator | Ultrasound guided block of the SN and ONP with 7.5 ml of Ropivacaine 7.5 mg/ml injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea. |
|
| Placebo arm | Placebo Comparator | Ultrasound guided placebo block of the SN and ONP with 7.5 ml of isotonic saline solution injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Block of the SN and ONP | Procedure | 7.5 ml of Ropivacaine 7.5 mg/ml injected at each site |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain on knee flexion | 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. | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at rest | 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. | 24 hours postoperatively |
| Time to opioid intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Westergaard, MD | Department of Anesthesiology, Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Bispebjerg Hospital | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000082 | Acetaminophen |
| D009020 | Morphine |
| D017294 | Ondansetron |
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo block | Procedure | 7.5 ml of isotonic saline solution 154 mmol/l injected at each site |
|
|
| Paracetamol | Drug |
|
|
| Morphine | Drug | 5 mg as needed |
|
| Ondansetron | Drug | 4 mg i.v. as needed in the PACU |
|
|
| Metoclopramide | Drug | 10 mg tablet as needed in the postoperative period after discharge from the PACU |
|
|
First time the patient needs to take supplementary opioids in the postoperative period
| 24 hours postoperatively |
| Total opioid intake | Total dose of opioids taken in the first 24 hours postoperatively | 24 hours |
| Nausea | 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. | 24 hours postoperatively |
| Vomiting | Number of times the patient has vomited in the first 24 hours postoperatively. | 24 hours |
| Use of antiemetics | Total dose of antiemetics taken during the first 24 hours postoperatively | 24 hours |
| PACU length of stay | Total length of stay in the post anesthetic care unit (PACU) after the operation. | 24 hours |
| Function level: Barthel Index/100 | Modified Barthel Index/100 score 24 hours after the operation. | 24 hours |
| Function level: Short form (SF) -8 | Short form (SF) -8 questionnaire 24 hours postoperatively | 24 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D000588 |
| Amines |
| D000083 | Acetanilides |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D001549 | Benzamides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |