Controlled-Release Oxycodone For Postoperative Analgesia After Video-Assisted Thoracic Surgery
NCT ID: NCT00681174
Last Updated: 2012-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
22 participants
INTERVENTIONAL
2008-07-31
2010-11-30
Brief Summary
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The study drug will be compared with intravenous morphine administered 30 minutes before the end of anesthesia.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control
Control intervention will be intraoperative i.v. morphine administration 30 minutes before the end of anesthesia.
Morphine
0.15 mg/kg i.v. bolus, 30 minutes before the expected end of anesthesia
Paravertebral block
* 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.
Propofol
* 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)
Remifentanil
* 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)
Paracetamol
1 g i.v. bolus 30 min before the end of anesthesia; 1 g i.v. bolus q8h thereafter.
Morphine
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
CROxy
The intervention group will receive controlled-release oxycodone 1 h pre-operatively
oxycodone
20 mg p.o. 1 h before the start of anesthesia
Paravertebral block
* 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.
Propofol
* 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)
Remifentanil
* 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)
Paracetamol
1 g i.v. bolus 30 min before the end of anesthesia; 1 g i.v. bolus q8h thereafter.
Morphine
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
Interventions
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Morphine
0.15 mg/kg i.v. bolus, 30 minutes before the expected end of anesthesia
oxycodone
20 mg p.o. 1 h before the start of anesthesia
Paravertebral block
* 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.
Propofol
* 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)
Remifentanil
* 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)
Paracetamol
1 g i.v. bolus 30 min before the end of anesthesia; 1 g i.v. bolus q8h thereafter.
Morphine
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be able to swallow tablets 1 h before surgery
* American Society of Anesthesiologists (ASA) physical status class I or II
Exclusion Criteria
* Acute myocardial infarction ≤6 months before enrollment
* Serum creatinine \> 2 mg/dL
* Body mass index (BMI) \> 30
* Diagnosis of psychiatric disorders
* Known or possible pregnancy
* Epilepsy
* Chronic opioid therapy or abuse
18 Years
65 Years
ALL
No
Sponsors
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University of Parma
OTHER
Responsible Party
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Guido Fanelli
Professor of Anesthesiology and Critical Care Medicine
Principal Investigators
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Guido Fanelli, MD
Role: STUDY_CHAIR
Section of Anesthesiology and Critical Care, Dept. of Anesthesiology, University of Parma, Italy
Marco Berti, MD
Role: STUDY_DIRECTOR
II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, Italy
Franca Bridelli, MD
Role: PRINCIPAL_INVESTIGATOR
II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, Italy
Locations
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University Hospital / Azienda Ospedaliero-Universitaria
Parma, PR, Italy
Countries
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References
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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.
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.
Other Identifiers
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ANEST-TOR-01
Identifier Type: -
Identifier Source: org_study_id
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