Failure to enroll sufficient patients by expected deadline.
Preoperative Controlled-Release Oxycodone or Intraoperative Morphine As Transition Opioid After Intravenous Anesthesia For Video-Assisted Thoracic Surgery: a Randomized, Double-blind, Controlled Trial.
Sponsor study identifier
interventional
22
1 country
1
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Actual (reported)Study Completion
November 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 19, 2008
Actual (reported)May 21, 2008
Actual (reported)July 2008
Date type not reportedThis date has not been verified as actual or estimated.
November 2010
Actual (reported)November 2010
Actual (reported)Morphine consumption (intravenous titration in PACU + i.v. patient-controlled pump usage)
48 h
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
Nausea or vomiting
Control intervention will be intraoperative i.v. morphine administration 30 minutes before the end of anesthesia.
The intervention group will receive controlled-release oxycodone 1 h pre-operatively
0.15 mg/kg i.v. bolus, 30 minutes before the expected end of anesthesia
20 mg p.o. 1 h before the start of anesthesia
University Hospital / Azienda Ospedaliero-Universitaria
Parma, PR, 43100, Italy
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.
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.
Guido Fanelli, MD
Section of Anesthesiology and Critical Care, Dept. of Anesthesiology, University of Parma, Italy
Marco Berti, MD
II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, Italy
Franca Bridelli, MD
II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, Italy
22 participants (actual enrollment reported by the registry).
First Submitted
May 19, 2008
First Posted
May 21, 2008
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
OXY-1: The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain
48 h
Respiratory depression (SpO2 < 92% or respiratory rate <8)
48 h
* Three injections of 0.5% ropivacaine, 5 ml each * Injections at the T5, T6 and T7 levels 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.
* Plasma concentration target-controlled infusion based on bispectral index values * Acceptable range of concentrations: 2-4 µg/mL * Target bispectral index values: 40-60 * Infusion starts at 4 µg/ml target, after pre-oxygenation (i.e., start of anesthesia)
* 50 µg/mL i.v. solution infused at 0.05-0.2 µg/kg/min * Infusion starts 7 min before propofol infusion (i.e., start of anesthesia) * Infusion rate adjusted to maintain mean arterial blood pressure within ±20% of baseline values. * Infusion stopped after end of surgery and after patients are brought back to the supine position (i.e., end of anesthesia)
1 g i.v. bolus 30 min before the end of anesthesia; 1 g i.v. bolus q8h thereafter.
Patient-controlled intravenous infusion pump (IV-PCA). * 50 mg morphine in 50 ml saline solution (1 mg/ml) * Incremental dose: 1 mg * Lock-out time: 8 min * Limit: 40 mg in 4 h * Background infusion: none
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
Primary Completion
November 2010
Actual (reported)Study Completion
November 2010
Actual (reported)Last Updated
January 6, 2012
Record last verified: 2012-01
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Source: ClinicalTrials.gov.
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