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

Sponsor

University of Parma (Other)

Overall Status

Terminated

CT.gov ID

NCT00681174

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, 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.

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Other Names:

Paravertebral nerve block

Naropin®

Drug: Propofol

Other Names:

Propofol TCI

target-controlled infusion

TIVA

TCI-TIVA

TIVA-TCI

Diprivan®

Drug: Remifentanil

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

Outcome Measures

Primary Outcome Measures

Morphine consumption (intravenous titration in PACU + i.v. patient-controlled pump usage) [48 h]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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