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

University of Parma

Status and phase: Terminated; Phase 4

Conditions: Anesthesia Recovery Period; Pain, Postoperative

Treatments: Drug: oxycodone; Drug: Propofol; Procedure: Paravertebral block; Drug: Morphine; Drug: Paracetamol; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT00681174

ANEST-TOR-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

22 participants in 2 patient groups

Control

Active Comparator group

Description:

Control intervention will be intraoperative i.v. morphine administration 30 minutes before the end of anesthesia.

Treatment:

Drug: Paracetamol

Drug: Remifentanil

Procedure: Paravertebral block

Drug: Morphine

Drug: Morphine

Drug: Propofol

CROxy

Experimental group

Description:

The intervention group will receive controlled-release oxycodone 1 h pre-operatively

Treatment:

Drug: Paracetamol

Drug: Remifentanil

Procedure: Paravertebral block

Drug: oxycodone

Drug: Morphine

Drug: Morphine

Drug: Propofol