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

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

Interventions

DRUG

Morphine

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

DRUG

oxycodone

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

PROCEDURE

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.

DRUG

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)

DRUG

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)

DRUG

Paracetamol

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

DRUG

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

Sponsors & Collaborators

• University of Parma

  lead OTHER

Principal Investigators

• 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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2010-11-30

Completion

2010-11-30

Countries

• Italy

Study Locations