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Failure to enroll sufficient patients by expected deadline.
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The main hypothesis of this study is that preoperative administration of controlled-release (CR) oxycodone may reduce acute postoperative pain and improve time to discharge from the post-anesthesia care unit in patients undergoing video-assisted thoracoscopy for spontaneous pneumothorax.
The study drug will be compared with intravenous morphine administered 30 minutes before the end of anesthesia.
Although spontaneous pneumothorax may be treated conservatively by simple observation or chest tube insertion, up to 50% of patients treated conservatively may experience recurrence in subsequent months or years.
Video-assisted thoracic surgery (VATS) is a minimally-invasive surgical approach to treat spontaneous pneumothorax and reduce the risk of recurrence. Compared to open thoracotomy, VATS may facilitate a faster recovery and lead to earlier home discharge.
Totally-intravenous anesthesia (TIVA) with propofol and remifentanil is a useful anesthetic technique for VATS, as the drugs are rapidly eliminated after the end of the procedure, leading to fast recovery from anesthesia.
One drawback of ultra-short-acting opioid remifentanil is residual hyperalgesia after the end of the infusion, particularly after VATS, which is associated with relatively short but intense pain after surgery.
Intravenous morphine, administered just before the end of anesthesia, is the typical choice for pain relief after TIVA. However, this drug may require repeated titration and may be associated with postoperative nausea and vomiting, itchiness or drowsiness in the early postoperative period.
Oxycodone, another opioid, is available in an oral controlled-release (CR) formulation which grants relatively constant plasma levels of the drug after 1 h of administration.
The investigators hypothesize that administration of CR oxycodone 20 mg 1 hour before surgery may lead to better recovery parameters in the post-anesthesia care unit, thus granting earlier discharge to the surgical ward.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Control intervention will be intraoperative i.v. morphine administration 30 minutes before the end of anesthesia. |
|
| CROxy | Experimental | The intervention group will receive controlled-release oxycodone 1 h pre-operatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine | Drug | 0.15 mg/kg i.v. bolus, 30 minutes before the expected end of anesthesia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption (intravenous titration in PACU + i.v. patient-controlled pump usage) | 48 h |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity as measured on a visual analog scale | 1 h after end of anesthesia | |
| Time to discharge from post-anesthesia care unit (Aldrete score >9) | 0-12 h after end of anesthesia | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guido Fanelli, MD | Section of Anesthesiology and Critical Care, Dept. of Anesthesiology, University of Parma, Italy | Study Chair |
| Marco Berti, MD | II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, Italy | Study Director |
| Franca Bridelli, MD | II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital / Azienda Ospedaliero-Universitaria | Parma | PR | 43100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14512683 | Background | Noppen M, Baumann MH. Pathogenesis and treatment of primary spontaneous pneumothorax: an overview. Respiration. 2003 Jul-Aug;70(4):431-8. doi: 10.1159/000072911. | |
| 16223391 | Background | Hansen EG, Duedahl TH, Romsing J, Hilsted KL, Dahl JB. Intra-operative remifentanil might influence pain levels in the immediate post-operative period after major abdominal surgery. Acta Anaesthesiol Scand. 2005 Nov;49(10):1464-70. doi: 10.1111/j.1399-6576.2005.00861.x. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D010098 | Oxycodone |
| D000077212 | Ropivacaine |
| D015742 | Propofol |
| D000077208 | Remifentanil |
| D000082 | Acetaminophen |
| D010323 | Passive Cutaneous Anaphylaxis |
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| oxycodone |
| Drug |
20 mg p.o. 1 h before the start of anesthesia |
|
|
| Paravertebral block | Procedure |
A 22G spinal needle will be used to contact the ipsilateral transverse process; the needle will be "walked off" the process and the injection will be made 1 cm deeper. |
|
|
| Propofol | Drug |
|
|
|
| Remifentanil | Drug |
|
|
|
| Paracetamol | Drug | 1 g i.v. bolus 30 min before the end of anesthesia; 1 g i.v. bolus q8h thereafter. |
|
|
| Morphine | Drug | Patient-controlled intravenous infusion pump (IV-PCA).
|
|
|
| Nausea or vomiting |
| 48 h |
| Respiratory depression (SpO2 < 92% or respiratory rate <8) | 48 h |
| 8844441 | Background | Sunshine A, Olson NZ, Colon A, Rivera J, Kaiko RF, Fitzmartin RD, Reder RF, Goldenheim PD. Analgesic efficacy of controlled-release oxycodone in postoperative pain. J Clin Pharmacol. 1996 Jul;36(7):595-603. doi: 10.1002/j.1552-4604.1996.tb04223.x. |
| 16199417 | Background | Vogt A, Stieger DS, Theurillat C, Curatolo M. Single-injection thoracic paravertebral block for postoperative pain treatment after thoracoscopic surgery. Br J Anaesth. 2005 Dec;95(6):816-21. doi: 10.1093/bja/aei250. Epub 2005 Sep 30. |
| 17023279 | Background | Kaya FN, Turker G, Basagan-Mogol E, Goren S, Bayram S, Gebitekin C. Preoperative multiple-injection thoracic paravertebral blocks reduce postoperative pain and analgesic requirements after video-assisted thoracic surgery. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):639-43. doi: 10.1053/j.jvca.2006.03.022. Epub 2006 Aug 8. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| 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 |
| D003061 | Codeine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000083 | Acetanilides |
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D000937 | Antigen-Antibody Reactions |
| D055633 | Immune System Phenomena |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |