Clinical trial NCT00681174: Controlled-Release Oxycodone For Postoperative Analgesia After Video-Assisted Thoracic Surgery
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anesthesia Recovery Period
Pain, Postoperative
Keywords: Care, Postoperative
Analgesia
Analgesics, Opioid
Morphine
Remifentanil
Oxycodone
Anesthesia, Regional
Anesthesia, Intravenous
Preanesthetic Medication
Analgesia, Patient-Controlled
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2008-05-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Morphine consumption (intravenous titration in PACU + i.v. patient-controlled pump usage)
timeFrame: 48 h
Secondary outcomes:
measure: Pain intensity as measured on a visual analog scale
timeFrame: 1 h after end of anesthesia
measure: Time to discharge from post-anesthesia care unit (Aldrete score >9)
timeFrame: 0-12 h after end of anesthesia
measure: Nausea or vomiting
timeFrame: 48 h
measure: Respiratory depression (SpO2 < 92% or respiratory rate <8)
timeFrame: 48 h
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University Hospital / Azienda Ospedaliero-Universitaria
state: PR
Study officials:
affiliation: Section of Anesthesiology and Critical Care, Dept. of Anesthesiology, University of Parma, Italy
name: Guido Fanelli, MD
role: STUDY_CHAIR
affiliation: II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, Italy
name: Marco Berti, MD
role: STUDY_DIRECTOR
affiliation: II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, Italy
name: Franca Bridelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.1002/j.1552-4604.1996.tb04223.x.
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. doi: 10.1093/bja/aei250. Epub 2005 Sep 30.
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. doi: 10.1053/j.jvca.2006.03.022. Epub 2006 Aug 8.