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

Pain, Postoperative Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00681174
• Other study ID #: ANEST-TOR-01
• Status: Terminated
• Phase: Phase 4
• First received: May 19, 2008
• Last updated: January 5, 2012
• Start date: July 2008
• Est. completion date: November 2010

Study information

• Verified date: January 2012
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia Recovery Period
• Pain, Postoperative

Intervention

Drug:
• 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

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)
• 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

Locations

Country	Name	City	State
Italy	University Hospital / Azienda Ospedaliero-Universitaria	Parma	PR

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Hansen EG, Duedahl TH, Rømsing 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. — View Citation

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. Epub 2006 Aug 8. — View Citation

Noppen M, Baumann MH. Pathogenesis and treatment of primary spontaneous pneumothorax: an overview. Respiration. 2003 Jul-Aug;70(4):431-8. Review. — View Citation

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. — View Citation

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. Epub 2005 Sep 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption (intravenous titration in PACU + i.v. patient-controlled pump usage)		48 h	No
Secondary	Pain intensity as measured on a visual analog scale		1 h after end of anesthesia	No
Secondary	Time to discharge from post-anesthesia care unit (Aldrete score >9)		0-12 h after end of anesthesia	Yes
Secondary	Nausea or vomiting		48 h	Yes
Secondary	Respiratory depression (SpO2 < 92% or respiratory rate <8)		48 h	Yes