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A randomized double-blind clinical trial was performed. There were 4 groups according to catheter placement and infusion constituents: 1) Intraarticular catheter + anesthetics; 2) Intraarticular catheter +placebo; 3) Subfascial catheter + anesthetics; 4) Subfascial catheter + placebo. The anesthetics infusion contained bupivacaine (bolus + continuous perfusion up to 36 hours). The placebo solution consisted in physiological serum (bolus + continuous perfusion up to 36 hours). Randomization was performed in the hospital pharmacy and the surgeon kept out the surgical field when the resident placed the catheter. The same conventional analgesic schedule was prescribed to all patients: PCA (patient controlled analgesia) + paracetamol 1g/6h + dexketoprofen 50mg/12h. The pain was evaluated by means of PCA (patient controlled analgesia) shots and the VAS (visual analog scale). Side effects, time to start rehabilitation and time to discharge were also analyzed. A statistical analysis was performed to compare all this variables between the 4 groups (SPSS 18.0).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraarticular Catheter with anesthesic | Active Comparator | Intraarticular infusion with Bupivacaine Hydrochloride |
|
| Intraarticular Physiological Saline | Placebo Comparator | Infusion of Physiological Saline [Flebobag Salina Fisiologica Grifols 0.9%] Sterile Solution by intraarticular catheter |
|
| Perifascial Catheter with anesthesic | Active Comparator | Perifascial infusion with Bupivacaine Hydrochloride |
|
| Perifascial Physiological Saline | Placebo Comparator | Infusion of Physiological Saline [Flebobag Salina Fisiologica Grifols 0.9%] Sterile Solution by Perifascial catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine hydrochloride | Drug | Intraarticular infusion with bupivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain measured with a visual analog scale | Visual analog pain scale score every eight hours for 36 hours postoperatively | 36 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Pérez Prieto | Hospital del Mar | Principal Investigator |
| Marta Cuenca Llavall | Hospital del Mar | Study Chair |
| Fernando Marques Lopez | Hospital del Mar | Study Director |
| Alfonso Leon Garcia | Hospital del Mar | Study Chair |
| Francisco Javier Santiveri Papiol | Hospital del Mar | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | Barcelona | 08003 | Spain |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D025981 | Hip Injuries |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Physiological Saline | Other | Intraarticular infusion physiological serum |
|
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |