Pain, PostoperativePhase 4NCT05515822
Use of Oxycodone in Bariatric Surgery
A Phase 4 study testing Oxycodone Hydrochloride, Dezocine and Esketamine and Oxycodone in people with Pain, Postoperative, run by Qiang Fu.
Trial summary
There is still no effective treatment for surgical pain, especially visceral pain in bariatric surgery. Oxycodone has great application prospect in patients with obesity, but there are few clinical studies and analgesic effect is still unclear, especially in combination with esketamine. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Oxycodone Hydrochloride, Dezocine and Esketamine and Oxycodone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Sep 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) ≥30kg/m2;
- Laparoscopic sleeve gastrectomy (LSG) was performed;
- American Society of Anesthesiologists (ASA) Grade I to II, age: 18-50;
- Patient-controlled intravenous analgesia (PCIA) was approved.
Who cannot join
- Do not agree to sign informed consent or cannot sign for other reasons;
- Oxycodone contraindications;
- Patients with contraindications to esketamine;
- Disocine contraindications;
- Preoperative history of opioid allergy and abuse;
- Have a long history of alcoholism;
- A history of surgery or anesthesia recently;
- Changes in standard anesthesia procedures for any reason.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Use of Oxycodone in Multimodel Perioperative Analgesia of Bariatric Surgery and Its Effect on Inflammatory Factors
There is still no effective treatment for surgical pain, especially visceral pain in bariatric surgery. Oxycodone has great application prospect in patients with obesity, but there are few clinical studies and analgesic effect is still unclear, especially in combination with esketamine.
This study was a prospective, single-center, randomized, controlled, double-blind clinical trial to compare the efficacy and safety of intravenous oxycodone and combined use of esketamine for perioperative multimodel analgesia during bariatric surgery, and the effect of esketamine on inflammatory factors.
This study was based on the hypothesis that oxycodone and the combination use with esketamine can effectively reduce the level of postoperative pain and inflammatory factors, and does not increase perioperative adverse reactions in bariatric surgery.
Read the detailed description
The ideal analgesia for bariatric surgery in obese individuals is one that provides effective analgesia for gastrointestinal trauma and abdominal wall incisions without inhibiting respiratory and gastrointestinal recovery. Although many researches have been done on surgical analgesia, there is still no very effective treatment for pain caused by surgery, especially visceral pain.
Oxycodone is a new type of opioid with pure μ and κ receptor double agonists. κ-receptor agonist has specific analgesic effect on visceral pain. Studies have found that oxycodone has obvious effect on visceral pain after abdominal surgery, and at the same time, oxycodone almost does not affect respiration and gastrointestinal peristalsis, which has great application prospect in obese people. However, opioids (including oxycodone) can cause drug tolerance and hyperalgesia, which may be mediated by NMDA receptor activation in the central nervous system. Esketamine provides exact analgesic effect by antagonizing NMDA receptors, with mild respiratory depression and less gastrointestinal and psychiatric adverse reactions. As an analgesic adjuvant, it can reduce the consumption of opioids and increase the analgesic effect when used in combination with other drugs.
Therefore, a prospective, single-center, randomized, controlled, double-blind trial was designed to compare the efficacy and safety of intravenous oxycodone plus esketamine for perioperative multimodal analgesia and the effects on inflammatory cytokines levels during bariatric surgery.
Participants were divided into an intervention group with oxycodone or (and) esketamine, and a control group with dezocine. The main concerns are the effectiveness of postoperative analgesia and the occurrence of adverse reactions.
- Conditions
- Pain, Postoperative
- Being tested
- Oxycodone Hydrochloride, Dezocine, Esketamine and Oxycodone
- Keywords
- Oxycodone, Acute Postoperative Pain, clinical randomized trial
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone HydrochlorideDrug
Also called Oxycodone group, Experimental
The doses were calculated according to the ideal body weight. Oxycodone was administered within 30min before the end of surgery. The parameters of patient controlled intravenous analgesia (PCIA) pump were set as continuous volume: 0ml, PCA: 6ml, lock time: 5min, extreme limit: 30ml, and connect with peripheral venous access at the beginning of skin suture.
DezocineDrug
Also called Dezocine group, Active Comparator
Dezocine was administered within 30min before the end of surgery. The parameters of patient controlled intravenous analgesia (PCIA) pump were set as continuous volume: 0ml, PCA: 6ml, lock time: 5min, extreme limit: 30ml, and connect with peripheral venous access at the beginning of skin suture.
Esketamine and OxycodoneDrug
Also called Esketamine+Oxycodone group, Experimental
Esketamine was administered 5min before skin incision, and Oxycodone was administered within 30min before the end of surgery. The parameters of patient controlled intravenous analgesia (PCIA) pump were set as continuous volume: 0ml, PCA: 6ml, lock time: 5min, extreme limit: 30ml, and connect with peripheral venous access at the beginning of skin suture.
| Study group | Role | What they receive |
|---|---|---|
| Dezocine group | Active comparator | Dezocine (1ml: 5mg) was administered 30 minutes before the end of surgery (0.15mg/kg i.v.) and during patient controlled intravenous analgesia (Dezocine 30mg+ Tropisetron 10mg+Saline, total 200ml) Receives: Drug: Dezocine |
| Oxycodone group | Experimental | Oxycodone (1ml: 10mg) was administered 30 minutes before the end of surgery (0.15mg/kg i.v.) and during patient controlled intravenous analgesia (Oxycodone 30mg+ Tropisetron 10mg+Saline, total 200ml) Receives: Drug: Oxycodone Hydrochloride |
| Esketamine+Oxycodone group | Experimental | Esketamine (2ml: 50mg) was administered 5 minutes before incision (0.15mg/kg i.v.), while Oxycodone was administered 30 minutes before the end of surgery (0.15mg/kg i.v.) and during patient controlled intravenous analgesia (Oxycodone 30mg+ Tropisetron 10mg+Saline, total 200ml) Receives: Drug: Esketamine and Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in postoperative pain
The Visual analogue Scale (VAS) was used to evaluate the intensity of postoperative resting state, motor state, and visceral pain within 48 hours after surgery. VAS ranges from 0 to 10, where 0 represents no pain and 10 represents excruciating pain, with higher scores indicating greater pain.
Measured: Within 48 hours after surgery.
Postoperative opioid consumption
The total postoperative opioid consumption was recorded within 48 hours after surgery. Postoperative opioid consumption was evaluated using intravenous morphine equivalent (IVME).
Measured: Within 48 hours after surgery.
Secondary outcomes (8)
Postoperative nausea and vomiting
Postoperative nausea and vomiting (PONV) was evaluated within 48 hours after surgery. 11-point verbal numeric rating scale (VNRS) was used to evaluate nausea (none:0, mild: 1-3, moderate:4-6, severe 7-10). Vomiting was considered a condition of retching symptom or the presence of vomit.
Measured: Within 48 hours after surgery.
Time to extubation
The total extubation time from the end of surgery to the removal of the endotracheal tube was evaluated after surgery.
Measured: Intraoperative (From the end of surgery to the removal of the endotracheal tube)
Ramsay sedation score
Ramsay sedation score was evaluated within 48 hours after surgery. Ramsay sedation score from 1 to 6, with higher scores indicating deeper the sedation.
Measured: Within 48 hours after surgery.
Finger pulse oxygen saturation (SpO2)
Finger pulse oxygen saturation (SpO2) was evaluated within 48 hours after surgery.
Measured: Within 48 hours after surgery.
Adverse effect
Perioperative adverse effects such as shivering, blurred vision, headache, dizziness, dry mouth, respiratory depression during postoperative to discharge.
Measured: During the hospital stay after surgery, an expected average of three days.
Total amount of anesthetic drugs used
Total amount of anesthetic drugs Propofol, Remifentanil and (or) sevoflurane used was evaluated during the whole surgery.
Measured: Intraoperative (During the whole bariatric surgery)
Total length of stay
Total length of stay was evaluated from postoperative to discharge.
Measured: During the hospital stay after surgery, an expected average of three days.
First time to get out of bed after surgery
First time to get out of bed after surgery was evaluated after surgery.
Measured: During the hospital stay after surgery, an expected average of three days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Model description
- Control group: Dezocine +Patient-controlled intravenous analgesia (Dezocine) ; Intervention group A: Oxycodone +Patient-controlled intravenous analgesia (Oxycodone); Intervention group B: Esketamine + Oxycodone +Patient-controlled intravenous analgesia (Oxycodone) .
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiang Fu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiang Fu, The Third People's Hospital of Chengdu
- Investigators
- Qiang Fu, Principal investigator, The Third People's Hospital of Chengdu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515822
- Sponsor's protocol ID
- ezmr2022-018
- Status last verified
- Aug 2022
- First submitted
- 21 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of the study will be published in the form of a paper, and the information of specific participants will be kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Oxycodone in Multimodel Perioperative Analgesia of Bariatric Surgery and Its Effect on Inflammatory Factors
- ClinicalTrials.gov ID
- NCT05515822
- Acronym / sponsor ID
- ezmr2022-018
- Conditions
- Pain, Postoperative
- Keywords
- Oxycodone, Acute Postoperative Pain, clinical randomized trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Qiang FuUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 25 Aug 2022 (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.
There is still no effective treatment for surgical pain, especially visceral pain in bariatric surgery. Oxycodone has great application prospect in patients with obesity, but there are few clinical studies and analgesic effect is still unclear, especially in combination with esketamine.
This study was a prospective, single-center, randomized, controlled, double-blind clinical trial to compare the efficacy and safety of intravenous oxycodone and combined use of esketamine for perioperative multimodel analgesia during bariatric surgery, and the effect of esketamine on inflammatory factors.
This study was based on the hypothesis that oxycodone and the combination use with esketamine can effectively reduce the level of postoperative pain and inflammatory factors, and does not increase perioperative adverse reactions in bariatric surgery.
Detailed description
The ideal analgesia for bariatric surgery in obese individuals is one that provides effective analgesia for gastrointestinal trauma and abdominal wall incisions without inhibiting respiratory and gastrointestinal recovery. Although many researches have been done on surgical analgesia, there is still no very effective treatment for pain caused by surgery, especially visceral pain.
Oxycodone is a new type of opioid with pure μ and κ receptor double agonists. κ-receptor agonist has specific analgesic effect on visceral pain. Studies have found that oxycodone has obvious effect on visceral pain after abdominal surgery, and at the same time, oxycodone almost does not affect respiration and gastrointestinal peristalsis, which has great application prospect in obese people. However, opioids (including oxycodone) can cause drug tolerance and hyperalgesia, which may be mediated by NMDA receptor activation in the central nervous system. Esketamine provides exact analgesic effect by antagonizing NMDA receptors, with mild respiratory depression and less gastrointestinal and psychiatric adverse reactions. As an analgesic adjuvant, it can reduce the consumption of opioids and increase the analgesic effect when used in combination with other drugs.
Therefore, a prospective, single-center, randomized, controlled, double-blind trial was designed to compare the efficacy and safety of intravenous oxycodone plus esketamine for perioperative multimodal analgesia and the effects on inflammatory cytokines levels during bariatric surgery.
Participants were divided into an intervention group with oxycodone or (and) esketamine, and a control group with dezocine. The main concerns are the effectiveness of postoperative analgesia and the occurrence of adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Control group: Dezocine +Patient-controlled intravenous analgesia (Dezocine) ; Intervention group A: Oxycodone +Patient-controlled intravenous analgesia (Oxycodone); Intervention group B: Esketamine + Oxycodone +Patient-controlled intravenous analgesia (Oxycodone) .
| Arm | Type | Receives |
|---|---|---|
| Dezocine group | Active comparator | Drug: DezocineDezocine (1ml: 5mg) was administered 30 minutes before the end of surgery (0.15mg/kg i.v.) and during patient controlled intravenous analgesia (Dezocine 30mg+ Tropisetron 10mg+Saline, total 200ml) |
| Oxycodone group | Experimental | Drug: Oxycodone HydrochlorideOxycodone (1ml: 10mg) was administered 30 minutes before the end of surgery (0.15mg/kg i.v.) and during patient controlled intravenous analgesia (Oxycodone 30mg+ Tropisetron 10mg+Saline, total 200ml) |
| Esketamine+Oxycodone group | Experimental | Drug: Esketamine and OxycodoneEsketamine (2ml: 50mg) was administered 5 minutes before incision (0.15mg/kg i.v.), while Oxycodone was administered 30 minutes before the end of surgery (0.15mg/kg i.v.) and during patient controlled intravenous analgesia (Oxycodone 30mg+ Tropisetron 10mg+Saline, total 200ml) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) ≥30kg/m2;
- Laparoscopic sleeve gastrectomy (LSG) was performed;
- American Society of Anesthesiologists (ASA) Grade I to II, age: 18-50;
- Patient-controlled intravenous analgesia (PCIA) was approved.
Key exclusion criteria (8 listed)
- Do not agree to sign informed consent or cannot sign for other reasons;
- Oxycodone contraindications;
- Patients with contraindications to esketamine;
- Disocine contraindications;
- Preoperative history of opioid allergy and abuse;
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 HydrochlorideAlso: Oxycodone group, ExperimentalThe doses were calculated according to the ideal body weight. Oxycodone was administered within 30min before the end of surgery. The parameters of patient controlled intravenous analgesia (PCIA) pump were set as continuous volume: 0ml, PCA: 6ml, lock time: 5min, extreme limit: 30ml, and connect with peripheral venous access at the beginning of skin suture. | Drug | Oxycodone group |
| DezocineAlso: Dezocine group, Active ComparatorDezocine was administered within 30min before the end of surgery. The parameters of patient controlled intravenous analgesia (PCIA) pump were set as continuous volume: 0ml, PCA: 6ml, lock time: 5min, extreme limit: 30ml, and connect with peripheral venous access at the beginning of skin suture. | Drug | Dezocine group |
| Esketamine and OxycodoneAlso: Esketamine+Oxycodone group, ExperimentalEsketamine was administered 5min before skin incision, and Oxycodone was administered within 30min before the end of surgery. The parameters of patient controlled intravenous analgesia (PCIA) pump were set as continuous volume: 0ml, PCA: 6ml, lock time: 5min, extreme limit: 30ml, and connect with peripheral venous access at the beginning of skin suture. | Drug | Esketamine+Oxycodone group |
Primary outcome
Changes in postoperative pain
Time frame: Within 48 hours after surgery.
The Visual analogue Scale (VAS) was used to evaluate the intensity of postoperative resting state, motor state, and visceral pain within 48 hours after surgery. VAS ranges from 0 to 10, where 0 represents no pain and 10 represents excruciating pain, with higher scores indicating greater pain.
Postoperative opioid consumption
Time frame: Within 48 hours after surgery.
The total postoperative opioid consumption was recorded within 48 hours after surgery. Postoperative opioid consumption was evaluated using intravenous morphine equivalent (IVME).
8 secondary outcomes
Postoperative nausea and vomiting
Time frame: Within 48 hours after surgery.
Time to extubation
Time frame: Intraoperative (From the end of surgery to the removal of the endotracheal tube)
Ramsay sedation score
Time frame: Within 48 hours after surgery.
Finger pulse oxygen saturation (SpO2)
Time frame: Within 48 hours after surgery.
Adverse effect
Time frame: During the hospital stay after surgery, an expected average of three days.
Total amount of anesthetic drugs used
Time frame: Intraoperative (During the whole bariatric surgery)
Total length of stay
Time frame: During the hospital stay after surgery, an expected average of three days.
First time to get out of bed after surgery
Time frame: During the hospital stay after surgery, an expected average of three days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No. The results of the study will be published in the form of a paper, and the information of specific participants will be kept confidential.
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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.
Qiang Fu principal investigator
The Third People's Hospital of Chengdu
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone Hydrochloride, Dezocine and Esketamine and Oxycodone in people with Pain, Postoperative, run by Qiang Fu.
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 4 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: status not confirmed, as of the sponsor's last update on 25 Aug 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiang Fu (18981757992, fuqiang1878@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in postoperative pain (time frame: Within 48 hours after surgery.). The study lists 2 primary outcomes in all. 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 25 Aug 2022.