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

This study has been terminated.
(Failure to enroll sufficient patients by expected deadline.)
Sponsor:
Information provided by (Responsible Party):
Guido Fanelli, University of Parma
ClinicalTrials.gov Identifier:
NCT00681174
First received: May 19, 2008
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Anesthesia Recovery Period
Pain, Postoperative
Drug: Morphine
Drug: oxycodone
Procedure: Paravertebral block
Drug: Propofol
Drug: Remifentanil
Drug: Paracetamol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Controlled-Release Oxycodone or Intraoperative Morphine As Transition Opioid After Intravenous Anesthesia For Video-Assisted Thoracic Surgery: a Randomized, Double-blind, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Parma:

Primary Outcome Measures:
  • Morphine consumption (intravenous titration in PACU + i.v. patient-controlled pump usage) [ Time Frame: 48 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain intensity as measured on a visual analog scale [ Time Frame: 1 h after end of anesthesia ] [ Designated as safety issue: No ]
  • Time to discharge from post-anesthesia care unit (Aldrete score >9) [ Time Frame: 0-12 h after end of anesthesia ] [ Designated as safety issue: Yes ]
  • Nausea or vomiting [ Time Frame: 48 h ] [ Designated as safety issue: Yes ]
  • Respiratory depression (SpO2 < 92% or respiratory rate <8) [ Time Frame: 48 h ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: July 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Control intervention will be intraoperative i.v. morphine administration 30 minutes before the end of anesthesia.
Drug: Morphine
0.15 mg/kg i.v. bolus, 30 minutes before the expected end 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.

Other Names:
  • Paravertebral nerve block
  • Naropin®
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)
Other Names:
  • Propofol TCI
  • target-controlled infusion
  • TIVA
  • TCI-TIVA
  • TIVA-TCI
  • Diprivan®
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)
Other Names:
  • TIVA
  • Ultiva®
Drug: Paracetamol
1 g i.v. bolus 30 min before the end of anesthesia; 1 g i.v. bolus q8h thereafter.
Other Names:
  • Acetaminophen
  • Perfalgan®
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
Other Names:
  • PCA
  • IVPCA
  • IV-PCA
  • PCA-IV
  • Patient-controlled analgesia
Experimental: CROxy
The intervention group will receive controlled-release oxycodone 1 h pre-operatively
Drug: oxycodone
20 mg p.o. 1 h before the start of anesthesia
Other Names:
  • controlled-release oxycodone
  • CR oxycodone
  • OxyContin®
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.

Other Names:
  • Paravertebral nerve block
  • Naropin®
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)
Other Names:
  • Propofol TCI
  • target-controlled infusion
  • TIVA
  • TCI-TIVA
  • TIVA-TCI
  • Diprivan®
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)
Other Names:
  • TIVA
  • Ultiva®
Drug: Paracetamol
1 g i.v. bolus 30 min before the end of anesthesia; 1 g i.v. bolus q8h thereafter.
Other Names:
  • Acetaminophen
  • Perfalgan®
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
Other Names:
  • PCA
  • IVPCA
  • IV-PCA
  • PCA-IV
  • Patient-controlled analgesia

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681174

Locations
Italy
University Hospital / Azienda Ospedaliero-Universitaria
Parma, PR, Italy, 43100
Sponsors and Collaborators
University of Parma
Investigators
Study Chair: Guido Fanelli, MD Section of Anesthesiology and Critical Care, Dept. of Anesthesiology, University of Parma, Italy
Study Director: Marco Berti, MD II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, Italy
Principal Investigator: Franca Bridelli, MD II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, Italy
  More Information

Publications:
Responsible Party: Guido Fanelli, Professor of Anesthesiology and Critical Care Medicine, University of Parma
ClinicalTrials.gov Identifier: NCT00681174     History of Changes
Other Study ID Numbers: ANEST-TOR-01
Study First Received: May 19, 2008
Last Updated: January 5, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Parma:
Care, Postoperative
Analgesia
Analgesics, Opioid
Morphine
Remifentanil
Oxycodone
Anesthesia, Regional
Anesthesia, Intravenous
Preanesthetic Medication
Analgesia, Patient-Controlled

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Anesthetics
Morphine
Oxycodone
Propofol
Remifentanil
Analgesics
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014