Anesthesia Recovery PeriodPhase 4NCT00681174
Controlled-Release Oxycodone For Postoperative Analgesia After Video-Assisted Thoracic Surgery
A Phase 4 study testing Morphine, oxycodone and Paravertebral block in people with Anesthesia Recovery Period and Pain, Postoperative, run by University of Parma at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia Recovery Period, Pain, Postoperative
- What is being tested?
- Morphine, oxycodone and Paravertebral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2008to Nov 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
University Hospital / Azienda Ospedaliero-Universitaria
Parma, PR, 43100
About this study
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.
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.
Read the 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.
- Conditions
- Anesthesia Recovery Period, Pain, Postoperative
- Being tested
- Morphine, oxycodone, Paravertebral block, Propofol, Remifentanil
- Keywords
- Care, Postoperative, Analgesia, Analgesics, Opioid, Morphine, Remifentanil, Oxycodone, Anesthesia, Regional, Anesthesia, Intravenous, Preanesthetic Medication, Analgesia, Patient-Controlled
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
0.15 mg/kg i.v. bolus, 30 minutes before the expected end of anesthesia
oxycodoneDrug
Also called controlled-release oxycodone, CR oxycodone, OxyContin®
20 mg p.o. 1 h before the start of anesthesia
Paravertebral blockProcedure or surgery
Also called Paravertebral nerve block, Naropin®
- 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.
PropofolDrug
Also called Propofol TCI, target-controlled infusion, TIVA, TCI-TIVA
- 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)
RemifentanilDrug
Also called TIVA, Ultiva®
- 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)
ParacetamolDrug
Also called Acetaminophen, Perfalgan®
1 g i.v. bolus 30 min before the end of anesthesia; 1 g i.v. bolus q8h thereafter.
MorphineDrug
Also called PCA, IVPCA, IV-PCA, PCA-IV
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
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control intervention will be intraoperative i.v. morphine administration 30 minutes before the end of anesthesia. Receives: Drug: Morphine; Procedure: Paravertebral block; Drug: Propofol; Drug: Remifentanil; Drug: Paracetamol |
| CROxy | Experimental | The intervention group will receive controlled-release oxycodone 1 h pre-operatively Receives: Drug: oxycodone; Procedure: Paravertebral block; Drug: Propofol; Drug: Remifentanil; Drug: Paracetamol; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption (intravenous titration in PACU + i.v. patient-controlled pump usage)
Measured: 48 h
Secondary outcomes (4)
Pain intensity as measured on a visual analog scale
Measured: 1 h after end of anesthesia
Time to discharge from post-anesthesia care unit (Aldrete score >9)
Measured: 0-12 h after end of anesthesia
Nausea or vomiting
Measured: 48 h
Respiratory depression (SpO2 < 92% or respiratory rate <8)
Measured: 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Failure to enroll sufficient patients by expected deadline.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anesthesia Recovery PeriodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Fanelli, University of Parma
- Investigators
- Guido Fanelli, MD, Study chair, Section of Anesthesiology and Critical Care, Dept. of Anesthesiology, University of Parma, ItalyMarco Berti, MD, Study director, II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, ItalyFranca Bridelli, MD, Principal investigator, II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681174
- Sponsor's protocol ID
- ANEST-TOR-01
- Status last verified
- Jan 2012
- First submitted
- 19 May 2008
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 14512683Hansen 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.
PubMed 16223391Sunshine 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.
PubMed 8844441Vogt 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.
PubMed 16199417Kaya 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.
PubMed 17023279
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00681174
- Acronym / sponsor ID
- ANEST-TOR-01
- Conditions
- Anesthesia Recovery Period, Pain, Postoperative
- Keywords
- Care, Postoperative, Analgesia, Analgesics, Opioid, Morphine, Remifentanil, Oxycodone, Anesthesia, Regional, Anesthesia, Intravenous
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to enroll sufficient patients by expected deadline.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Morphine, Procedure: Paravertebral block, Drug: Propofol, Drug: Remifentanil, Drug: ParacetamolControl intervention will be intraoperative i.v. morphine administration 30 minutes before the end of anesthesia. |
| CROxy | Experimental | Drug: oxycodone, Procedure: Paravertebral block, Drug: Propofol, Drug: Remifentanil, Drug: Paracetamol, Drug: MorphineThe intervention group will receive controlled-release oxycodone 1 h pre-operatively |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine0.15 mg/kg i.v. bolus, 30 minutes before the expected end of anesthesia | Drug | Control |
| oxycodoneAlso: controlled-release oxycodone, CR oxycodone, OxyContin®20 mg p.o. 1 h before the start of anesthesia | Drug | CROxy |
| Paravertebral blockAlso: Paravertebral nerve block, Naropin®* 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. | Procedure or surgery | CROxy, Control |
| PropofolAlso: Propofol TCI, target-controlled infusion, TIVA, TCI-TIVA* 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) | Drug | CROxy, Control |
| RemifentanilAlso: TIVA, Ultiva®* 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) | Drug | CROxy, Control |
| ParacetamolAlso: Acetaminophen, Perfalgan®1 g i.v. bolus 30 min before the end of anesthesia; 1 g i.v. bolus q8h thereafter. | Drug | CROxy, Control |
| MorphineAlso: PCA, IVPCA, IV-PCA, PCA-IVPatient-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 | Drug | CROxy, Control |
Primary outcome
Morphine consumption (intravenous titration in PACU + i.v. patient-controlled pump usage)
Time frame: 48 h
4 secondary outcomes
Pain intensity as measured on a visual analog scale
Time frame: 1 h after end of anesthesia
Time to discharge from post-anesthesia care unit (Aldrete score >9)
Time frame: 0-12 h after end of anesthesia
Nausea or vomiting
Time frame: 48 h
Respiratory depression (SpO2 < 92% or respiratory rate <8)
Time frame: 48 h
Results and safety
The study was stopped early (reason given: Failure to enroll sufficient patients by expected deadline.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
- Background: PubMed 14512683Noppen M, Baumann MH. Pathogenesis and treatment of primary spontaneous pneumothorax: an overview. Respiration. 2003 Jul-Aug;70(4):431-8. doi: 10.1159/000072911.
- Background: PubMed 16223391Hansen 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.
- Background: PubMed 8844441Sunshine 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.
- Background: PubMed 16199417Vogt 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.
- Background: PubMed 17023279Kaya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Fanelli, MD study chair
Section of Anesthesiology and Critical Care, Dept. of Anesthesiology, University of Parma, Italy
Marco Berti, MD study director
II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, Italy
Franca Bridelli, MD principal investigator
II Unit of Anesthesia, Critical Care and Pain Medicine, University Hospital of Parma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine, oxycodone and Paravertebral block in people with Anesthesia Recovery Period and Pain, Postoperative, run by University of Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Failure to enroll sufficient patients by expected deadline.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (intravenous titration in PACU + i.v. patient-controlled pump usage) (time frame: 48 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00681174, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2012.