Controlled-Release Oxycodone For Postoperative Analgesia After Video-Assisted Thoracic Surgery

NCT00681174 | Terminated Phase 4 DMC

• 1 other identifier: ANEST-TOR-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia Recovery Period; Pain, Postoperative

Keywords

Care, Postoperative; Analgesia; Analgesics, Opioid; Morphine; Remifentanil; Oxycodone; Anesthesia, Regional; Anesthesia, Intravenous; Preanesthetic Medication; Analgesia, Patient-Controlled

Outcome Measures

Primary Outcomes (1)

• Morphine consumption (intravenous titration in PACU + i.v. patient-controlled pump usage)

  48 h

Secondary Outcomes (4)

• 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

  48 h

• Respiratory depression (SpO2 < 92% or respiratory rate <8)

  48 h

Study Arms (2)

Control

ACTIVE COMPARATOR

Control intervention will be intraoperative i.v. morphine administration 30 minutes before the end of anesthesia.

Drug: Morphine; Procedure: Paravertebral block; Drug: Propofol; Drug: Remifentanil; Drug: Paracetamol

CROxy

EXPERIMENTAL

The intervention group will receive controlled-release oxycodone 1 h pre-operatively

Drug: oxycodone; Procedure: Paravertebral block; Drug: Propofol; Drug: Remifentanil; Drug: Paracetamol; Drug: Morphine

Interventions

Morphine DRUG

0.15 mg/kg i.v. bolus, 30 minutes before the expected end of anesthesia

Control

oxycodone DRUG

20 mg p.o. 1 h before the start of anesthesia

Also known as: controlled-release oxycodone, CR oxycodone, OxyContin®

CROxy

Paravertebral block PROCEDURE

* 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.

Also known as: Paravertebral nerve block, Naropin®

CROxy; Control

Propofol DRUG

* 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)

Also known as: Propofol TCI, target-controlled infusion, TIVA, TCI-TIVA, TIVA-TCI, Diprivan®

CROxy; Control

Remifentanil DRUG

* 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)

Also known as: TIVA, Ultiva®

CROxy; Control

Paracetamol DRUG

1 g i.v. bolus 30 min before the end of anesthesia; 1 g i.v. bolus q8h thereafter.

Also known as: Acetaminophen, Perfalgan®

CROxy; Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for video-assisted thoracic surgery for clinical diagnosis of spontaneous pneumothorax
• Must be able to swallow tablets 1 h before surgery
• American Society of Anesthesiologists (ASA) physical status class I or II

You may not qualify if:

• Known allergy or other contraindications to study drugs
• 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

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

University Hospital / Azienda Ospedaliero-Universitaria

Parma, PR, 43100, Italy

Location

Related Publications (5)

• 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.

  PMID: 14512683 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.

  PMID: 16223391 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.

  PMID: 8844441 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.

  PMID: 16199417 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.

  PMID: 17023279 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Morphine; Oxycodone; Ropivacaine; Propofol; Remifentanil; Acetaminophen; Passive Cutaneous Anaphylaxis; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Acetanilides; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Analgesia; Anesthesia and Analgesia

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 21, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 6, 2012

Record last verified: 2012-01

Locations

IT (1)