PainPhase 3NCT02240602
Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery
A Phase 3 study testing Oxycodone, 1.00 mg dose, Oxycodone, 0.03 mg/kg dose and Oxycodone, 0.02 mg/kg dose in people with Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Postoperative pain control is required after major abdominal surgery, including laparoscopic colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control mainly in Europe. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- Oxycodone, 1.00 mg dose, Oxycodone, 0.03 mg/kg dose and Oxycodone, 0.02 mg/kg dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Dec 2016
- Phase
- Phase 3
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists class 1,2
- Expected surgical time between 2 - 6 hours
- Scheduled for laparoscopic colorectal surgery
Who cannot join
- Severe dysfunction of liver, heart, kidney, or lung
- Cannot understand numeric rating scale of pain
- Known or suspected allergy to oxycodone
- Previous history of postoperative nausea or vomiting
- Medication of antidepressants
- Postoperative long-term ICU care or prolonged mechanical ventilatory support
Show all 10Show fewer
- Chronic pain
- Drug abuser
- Hypersensitivity reaction to aspirin or NSAIDs
- Refuse to enroll
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative pain control is required after major abdominal surgery, including laparoscopic colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control mainly in Europe. The aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean.
Read the detailed description
Oxycodone is known to be effective in pain control and has less sedative effect than morphine does. It has been described that distribution of cytochrome P450, which is associated with metabolism of oxycodone, differed between the races. Proper dose of intravenous oxycodone after major abdominal surgery has not been well defined in Korean. The purpose of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean based on pain score and side effects.
- Conditions
- Pain
- Being tested
- Oxycodone, 1.00 mg dose, Oxycodone, 0.03 mg/kg dose, Oxycodone, 0.02 mg/kg dose
- Keywords
- acute pain, postoperative, surgery
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone, 1.00 mg doseDrug
Also called OxyNorm
Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg.
Oxycodone, 0.03 mg/kg doseDrug
Also called OxyNorm
Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.03 mg/kg.
Oxycodone, 0.02 mg/kg doseDrug
Also called OxyNorm
intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.02 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone, 1.00 mg dose | Experimental | Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 1.00 mg with lock out time of 10 min without basal infusion. Receives: Drug: Oxycodone, 1.00 mg dose |
| Oxycodone, 0.03 mg/kg dose | Experimental | Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 0.03 mg/kg with lock out time of 10 min without basal infusion. Receives: Drug: Oxycodone, 0.03 mg/kg dose |
| Oxycodone, 0.02 mg/kg dose | Experimental | Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 0.02 mg/kg with lock out time of 10 min without basal infusion. Receives: Drug: Oxycodone, 0.02 mg/kg dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
resting postoperative pain at 24hr
Primary outcome is resting postoperative pain at 24 hr after surgery with numeric rating scale 0-10.
Measured: 24 hr after surgery
Secondary outcomes (1)
side effects
Secondary outcome includes any side effect at 24 hr after surgery.
Measured: 24 hr after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startJul 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Lack of internal resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunseok Jeon, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240602
- Sponsor's protocol ID
- OxyNorm
- Status last verified
- Sep 2014
- First submitted
- 11 Sep 2014
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02240602
- Acronym / sponsor ID
- OxyNorm
- Conditions
- Pain
- Keywords
- acute pain, postoperative, surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of internal resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Sep 2014 (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.
Postoperative pain control is required after major abdominal surgery, including laparoscopic colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control mainly in Europe. The aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean.
Detailed description
Oxycodone is known to be effective in pain control and has less sedative effect than morphine does. It has been described that distribution of cytochrome P450, which is associated with metabolism of oxycodone, differed between the races. Proper dose of intravenous oxycodone after major abdominal surgery has not been well defined in Korean. The purpose of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean based on pain score and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxycodone, 1.00 mg dose | Experimental | Drug: Oxycodone, 1.00 mg doseRegimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 1.00 mg with lock out time of 10 min without basal infusion. |
| Oxycodone, 0.03 mg/kg dose | Experimental | Drug: Oxycodone, 0.03 mg/kg doseRegimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 0.03 mg/kg with lock out time of 10 min without basal infusion. |
| Oxycodone, 0.02 mg/kg dose | Experimental | Drug: Oxycodone, 0.02 mg/kg doseRegimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 0.02 mg/kg with lock out time of 10 min without basal infusion. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists class 1,2
- Expected surgical time between 2 - 6 hours
- Scheduled for laparoscopic colorectal surgery
Key exclusion criteria (10 listed)
- Severe dysfunction of liver, heart, kidney, or lung
- Cannot understand numeric rating scale of pain
- Known or suspected allergy to oxycodone
- Previous history of postoperative nausea or vomiting
- Medication of antidepressants
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 |
|---|---|---|
| Oxycodone, 1.00 mg doseAlso: OxyNormIntravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg. | Drug | Oxycodone, 1.00 mg dose |
| Oxycodone, 0.03 mg/kg doseAlso: OxyNormIntravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.03 mg/kg. | Drug | Oxycodone, 0.03 mg/kg dose |
| Oxycodone, 0.02 mg/kg doseAlso: OxyNormintravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.02 mg/kg. | Drug | Oxycodone, 0.02 mg/kg dose |
Primary outcome
resting postoperative pain at 24hr
Time frame: 24 hr after surgery
Primary outcome is resting postoperative pain at 24 hr after surgery with numeric rating scale 0-10.
1 secondary outcome
side effects
Time frame: 24 hr after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
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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.
Yunseok Jeon, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxycodone, 1.00 mg dose, Oxycodone, 0.03 mg/kg dose and Oxycodone, 0.02 mg/kg dose in people with Pain, run by Seoul National University Hospital at 1 site in South Korea.
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 10 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: withdrawn, as of the sponsor's last update on 16 Jun 2015. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
resting postoperative pain at 24hr (time frame: 24 hr after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2015.