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Anterior cruciate ligament reconstruction is a routine surgical procedure. Traditional femoral/sciatic block combinations effectively reduce postoperative pain, but results in considerable motor blockade. The investigators aimed to evaluate postoperative pain relief and the degree of motor block with block combinations of femoral nerve (FEM) and obturator [posterior branch] nerve (ONP), versus saphenous nerve (SAPH) and ONP, versus placebo blocks with isotonic saline. All patients received standard patient controlled analgesia with morphine.Randomized, placebo-controlled and double-blinded clinical trial. Following IRB approval, 81 patients were planned to be randomized to one of three USG block combinations: Active FEM+ONP, active SAPH+ONP or no active blocks (sham blocks) Ropivacaine 0.75% was used for all active blocks following induction of general anaesthesia [propofol-remifentanil, laryngeal mask airway]. Primary outcome measure: Localized PACU pain scores (AUC) 0-6 hours postoperatively at rest.
Secondary outcome measures: Opioid consumption, opioid related side effects, PACU time, motor abilities of daily living scores [modified Barthel/100 index], perceived ill health [Short form-8] scores and degree of motor blockade [Jensen- Børglum motor test].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active FEM+ONP | Active Comparator | Nerveblock of n. femoralis (FEM) with 10 ml Ropivacaine 7.5 mg/ml and nerveblock of obturator nerveposterior branch (ONP) with 10 ml Ropivacaine 7.5 mg/ml. |
|
| Active SAPH+ONP | Active Comparator | Nerveblock of n.saphenous (SAPH) with 5 ml Ropivacaine 7.5 mg/ml and nerveblock of obturator nerve, posterior branch (ONP) with 10 ml Ropivacaine 7.5 mg/ml |
|
| Placebo | Placebo Comparator | Saline 9 mg/ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| NRS (pain score) | Numerical rating scale(0-10) | Area under the curve (AUC) 0-6 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | Opioid consumption (PCA pump - mg of morphine) | 0-6 hours postoperatively |
| opioid related side effects | Nausea (0-3), vomiting (>10 ml) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital, department of anesthesiology | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| 0-6 hours postoperatively |
| PACU time | Minutes in PACU | 0-6 hours postoperatively |
| Motor abilities of of daily living | Modified Barthel/100 index | 0-24 hours postoperatively |
| Perceived ill health | Short-Form-8 | 0-24 hours postoperatively |
| Degree of motor block. | Jensen-Borglum motor test | 0-6 hours postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |