OxycodonePhase 1NCT05742256
Oxycodone in Combination With Parathoracic Nerve Block is Used for Postoperative Analgesia in Lung Cancer
A Phase 1 study testing Oxycodone 1mg/kg, Oxycodone 1.5mg/kg and Sufentanil in people with Oxycodone, run by Qianfoshan Hospital.
Trial summary
In this study, the effect of oxycodone combined with ultrasound-guided paravertebral nerve block on the postoperative analgesic effect of thoracoscopic lung cancer was investigated, and the effect and reasonable dose of oxycodone were explored, which provided a reference for the clinical multimodal analgesia after… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Oxycodone
- What is being tested?
- Oxycodone 1mg/kg, Oxycodone 1.5mg/kg and Sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 31 Dec 2024
- Phase
- Phase 1
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age > 60 years
- Patients undergoing thoracoscopic lobectomy
- ASA (American Academy of Anesthesiologists) Grades I-III
- There were no obvious abnormalities in heart, liver, and kidney function
- Sign the informed consent form for this clinical study
Who cannot join
- History of oxycodone or sufentanil allergy
- Renal or hepatic dysfunction
- History of drug or alcohol abuse
- Psychiatric disorders: schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis
- Those who have difficulty communicating due to coma, severe dementia, speech barrier, or those who cannot cooperate due to other diseases.
- People with head trauma or other brain diseases -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Oxycodone Combined With Ultrasound Guided Thoracic Paravertebral Nerve Block on Postoperative Analgesia in Patients With Lung Cancer Undergoing Thoracoscopic Surgery
In this study, the effect of oxycodone combined with ultrasound-guided paravertebral nerve block on the postoperative analgesic effect of thoracoscopic lung cancer was investigated, and the effect and reasonable dose of oxycodone were explored, which provided a reference for the clinical multimodal analgesia after thoracoscopic lung cancer surgery.
- Conditions
- Oxycodone
- Being tested
- Oxycodone 1mg/kg, Oxycodone 1.5mg/kg, Sufentanil
- Keywords
- Oxycodone, Postoperative analgesia, lung cancer, thoracic paravertebral nerve block
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone 1mg/kgDrug
Also called Oxycodone
Test group 1 (OCA group):oxycodone 1mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml
Oxycodone 1.5mg/kgDrug
Test group 2 (OCB group): oxycodone 1.5mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml.
SufentanilDrug
Control group (SF group): sufentanil 2ug/kg + flurbiprofen + ondansetron 16mg + 0.9% normal saline diluted to 100ml.
| Study group | Role | What they receive |
|---|---|---|
| Test group 1(OCA group) | Experimental | Not described Receives: Drug: Oxycodone 1mg/kg |
| Test group 2(OCB group) | Experimental | Not described Receives: Drug: Oxycodone 1.5mg/kg |
| Control group(SF group) | Active comparator | Not described Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main indicators were NRS scores at rest and cough at 24 h postoperatively.
NRS (numerical rating scale) is composed of 11 numbers from 0 to 10, and patients use 11 numbers from 0 to 10 to describe the intensity of pain, and the higher the number, the more severe the pain.
Measured: at 24h after surgery
Secondary outcomes (11)
Time to double-lumen tracheal extraction
Time to double-lumen tracheal extraction
Measured: Within two hours after surgery
NRS score at rest and cough
NRS (numerical rating scale) is composed of 11 numbers from 0 to 10, and patients use 11 numbers from 0 to 10 to describe the intensity of pain, and the higher the number, the more severe the pain.
Measured: at 2h , 4h, 12h, 48h after surgery
sedation score (Ramsay sedation score)
The Ramsay sedation score is the most widely used sedation scoring criterion in clinical practice. It is divided into six levels, reflecting three levels of wakefulness and three levels of sleep. The higher the level, the deeper the level of sedation.
Measured: at 2 h , 4 h , 12 h ,24 h,48 h postoperatively
sufentanil consumption
sufentanil consumption
Measured: Within 48 hours after surgery
oxycodone consumption
oxycodone consumption
Measured: Within 48 hours after surgery
analgesic pump compressions
analgesic pump compressions
Measured: Within 48 hours after surgery
additional analgesic doses
additional analgesic doses
Measured: Within 48 hours after surgery
incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin
incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin
Measured: Within 48 hours after surgery
gastrointestinal recovery (exhaust time)
gastrointestinal recovery (exhaust time)
Measured: Within 48 hours after surgery
laboratory results of C-reactive protein 1 day before and after surgery
laboratory results of C-reactive protein 1 day before and after surgery
Measured: Within 48 hours after surgery
laboratory results of interleukin-6 laboratory test 1 day before and after surgery
laboratory results of interleukin-6 laboratory test 1 day before and after surgery
Measured: Within 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OxycodoneStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pengcai Shi, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742256
- Sponsor's protocol ID
- YXLL-KY-2022(116)
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Y, Wu G, Liu Z, Wei X, Feng H, Su J, Shi P. Effect of oxycodone combined with ultrasound-guided thoracic paravertebral nerve block on postoperative analgesia in patients with lung cancer undergoing thoracoscopic surgery: protocol for a randomised controlled study. BMJ Open. 2023 Oct 16;13(10):e074416. doi: 10.1136/bmjopen-2023-074416.
PubMed 37844986
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxycodone Combined With Ultrasound Guided Thoracic Paravertebral Nerve Block on Postoperative Analgesia in Patients With Lung Cancer Undergoing Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT05742256
- Acronym / sponsor ID
- YXLL-KY-2022(116)
- Conditions
- Oxycodone
- Keywords
- Oxycodone, Postoperative analgesia, lung cancer, thoracic paravertebral nerve block
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Feb 2023 (actual)
- 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.
In this study, the effect of oxycodone combined with ultrasound-guided paravertebral nerve block on the postoperative analgesic effect of thoracoscopic lung cancer was investigated, and the effect and reasonable dose of oxycodone were explored, which provided a reference for the clinical multimodal analgesia after thoracoscopic lung cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test group 1(OCA group) | Experimental | Drug: Oxycodone 1mg/kg |
| Test group 2(OCB group) | Experimental | Drug: Oxycodone 1.5mg/kg |
| Control group(SF group) | Active comparator | Drug: Sufentanil |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, age > 60 years
- Patients undergoing thoracoscopic lobectomy
- ASA (American Academy of Anesthesiologists) Grades I-III
- There were no obvious abnormalities in heart, liver, and kidney function
- Sign the informed consent form for this clinical study
Key exclusion criteria (6 listed)
- History of oxycodone or sufentanil allergy
- Renal or hepatic dysfunction
- History of drug or alcohol abuse
- Psychiatric disorders: schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis
- Those who have difficulty communicating due to coma, severe dementia, speech barrier, or those who cannot cooperate due to other diseases.
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 1mg/kgAlso: OxycodoneTest group 1 (OCA group):oxycodone 1mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml | Drug | Test group 1(OCA group) |
| Oxycodone 1.5mg/kgTest group 2 (OCB group): oxycodone 1.5mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml. | Drug | Test group 2(OCB group) |
| SufentanilControl group (SF group): sufentanil 2ug/kg + flurbiprofen + ondansetron 16mg + 0.9% normal saline diluted to 100ml. | Drug | Control group(SF group) |
Primary outcome
The main indicators were NRS scores at rest and cough at 24 h postoperatively.
Time frame: at 24h after surgery
NRS (numerical rating scale) is composed of 11 numbers from 0 to 10, and patients use 11 numbers from 0 to 10 to describe the intensity of pain, and the higher the number, the more severe the pain.
11 secondary outcomes
Time to double-lumen tracheal extraction
Time frame: Within two hours after surgery
NRS score at rest and cough
Time frame: at 2h , 4h, 12h, 48h after surgery
sedation score (Ramsay sedation score)
Time frame: at 2 h , 4 h , 12 h ,24 h,48 h postoperatively
sufentanil consumption
Time frame: Within 48 hours after surgery
oxycodone consumption
Time frame: Within 48 hours after surgery
analgesic pump compressions
Time frame: Within 48 hours after surgery
additional analgesic doses
Time frame: Within 48 hours after surgery
incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin
Time frame: Within 48 hours after surgery
gastrointestinal recovery (exhaust time)
Time frame: Within 48 hours after surgery
laboratory results of C-reactive protein 1 day before and after surgery
Time frame: Within 48 hours after surgery
laboratory results of interleukin-6 laboratory test 1 day before and after surgery
Time frame: Within 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Derived from this study: PubMed 37844986Wang Y, Wu G, Liu Z, Wei X, Feng H, Su J, Shi P. Effect of oxycodone combined with ultrasound-guided thoracic paravertebral nerve block on postoperative analgesia in patients with lung cancer undergoing thoracoscopic surgery: protocol for a randomised controlled study. BMJ Open. 2023 Oct 16;13(10):e074416. doi: 10.1136/bmjopen-2023-074416.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxycodone 1mg/kg, Oxycodone 1.5mg/kg and Sufentanil in people with Oxycodone, run by Qianfoshan Hospital.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pengcai Shi, Chief physician (13791126828, shipc1997@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main indicators were NRS scores at rest and cough at 24 h postoperatively. (time frame: at 24h after surgery). 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 NCT05742256, which also lists 1 linked publication.
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 23 Feb 2023.