OxycodoneAOPCNCT06721988
Effect of Preventive Analgesia with Oxycodone and Parecoxib Sodium on the Chronification of Acute Post-operative Pain
A study testing oxycodone and parecoxib sodium combinations in people with Oxycodone and Chronic Pain, Postoperative, run by Ailin Luo.
Trial summary
The goal of this clinical trial is to learn if the administration of oxycodone for preventive analgesia works to reduce the chronification of acute postoperative pain in adult participants undergoing major abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oxycodone, Chronic Pain, Postoperative
- What is being tested?
- oxycodone and parecoxib sodium combinations
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,316 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ASA I~III；
- BMI ranging from 18 to 28 kg/m²；
- For elective laparoscopic-assisted major abdominal surgery under general anesthesia;
- Estimated surgical duration (from incision to the last suture of the skin) was at least 2 hours.
Who cannot join
- Pregnant or lactating patients;
- Patients diagnosed with septic shock or multiple organ failure within 14 days;
- Patients with preoperative severe electrolyte disorders;
- Patients with stroke, transient ischemic attack, or other similar events within the past 3 months
- Patients with unstable angina, myocardial infarction within the past 3 months; or presence of untreated arrhythmia or arrhythmia not well-controlled with treatment;
- Patients with diabetes, uncontrolled blood glucose levels, or diabetes complications such as diabetic ketoacidosis, hyperosmolar coma, diabetes-related infections, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic peripheral neuropathy, diabetic foot, etc. before the surgery;
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- Patients with severe liver dysfunction (Child-Pugh score > 6), renal dysfunction (GFR < 90 ml/(min•1.73m²));
- Exploratory surgeries, day surgeries, or surgeries that only involve opening and closing the abdomen;
- Blood pressure ≥180/110 mmHg at rest (≥Grade 3 hypertension according to the 2020 ISH Hypertension Guidelines); or systolic blood pressure <90 mmHg or mean blood pressure <65 mmHg;
- Patients participated in other drug trials within the past 3 months;
- Patients with communication difficulties, inability to understand pain scores or patient-controlled intravenous analgesia;
- Patients with consciousness disorders or other psychiatric illnesses;
- Patients with a confirmed or suspected history of substance abuse or long-term use of anesthetic sedatives and analgesics;
- Cancer patients have received neoadjuvant treatment or chemotherapy preoperatively;
- Allergic to the drugs used in this trial and their components.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Li Shiyong contact
About this study
Official title: Exploring the Effect of Preventive Analgesia with Oxycodone and Parecoxib Sodium on the Chronification of Acute Pain in Adult Patients Underwent Laparoscopic-assisted Abdominal Major Surgery
The goal of this clinical trial is to learn if the administration of oxycodone for preventive analgesia works to reduce the chronification of acute postoperative pain in adult participants undergoing major abdominal surgery. The main question it aims to answer is:
- Does administration of oxycodone before surgical incision reduce the occurrence of chronic pain or relieve the chronic pain symptoms 3 months after the operation? Researchers will compare oxycodone + parecoxib sodium to placebo + parecoxib sodium combinations to see if oxycodone works to reduce the chronification of acute postoperative pain.
Read more
Participants will:
- Take oxycodone + parecoxib sodium or placebo + parecoxib sodium combinations before the surgical incision
- Cooperate with the follow-up staffs and complete some checkups or tests within 3 months after the operation.
Read the detailed description
Preventive analgesia encompasses a range of analgesic strategies designed to mitigate hyperalgesia and allodynia induced by noxious stimuli by preventing peripheral and intraoperative sensitization to pain. It constitutes a fundamental component of multimodal analgesia. Nonsteroidal anti-inflammatory drugs (NSAIDs) are presently the most frequently employed agents for preventive analgesia, demonstrating efficacy in reducing the incidence of acute postoperative pain and chronic post-surgical pain. However, the management of acute postoperative pain and chronic post-surgical pain remains suboptimal. κ-opioid receptors are regarded as the primary receptors involved in the transmission of visceral pain, and κ-receptor agonists have been shown to effectively inhibit this transmission. Administering κ-receptor agonists via intravenous infusion either before the conclusion of surgery or postoperatively can substantially mitigate pain during the recovery period. This indicates that κ-receptor agonists possess potential as preventive analgesics. However, there is currently a paucity of high-quality clinical evidence supporting their use in preventive analgesia. Oxycodone functions as a dual agonist of μ-opioid and κ-opioid receptors and is extensively utilized in postoperative analgesia and anesthesia induction. Its safety and efficacy in pain management have been thoroughly validated. Theoretically, the concurrent administration of oxycodone and NSAIDs, which mitigate pain signal transmission through distinct mechanisms, could result in an additive preventive analgesic effect. However, there is currently a paucity of high-quality clinical evidence supporting this hypothesis. Consequently, this study seeks to investigate the effects of the combined administration of oxycodone and NSAIDs as preventive analgesia on the transition of acute postoperative pain to chronic pain in patients undergoing major abdominal surgery. The findings aim to contribute clinical evidence and theoretical insights to enhance perioperative pain management strategies.
- Conditions
- Oxycodone, Chronic Pain, Postoperative
- Being tested
- oxycodone and parecoxib sodium combinations, Placebo and parecoxib sodium combinations
- Keywords
- Oxycodone, Preventive analgesia, Chronification of acute postoperative pain
- 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 and parecoxib sodium combinationsDrug
Participants will receive 0.1ml/kg oxycodone (1mg/ml) and 2 ml parecoxib sodium (20 mg/ml) combinations after the anesthesia induction but before the surgical incision. Oxycodone is administered 5 minutes after parecoxib sodium administration.
Placebo and parecoxib sodium combinationsDrug
Participants will receive 0.1ml/kg placebo (0.9% saline) and 2 ml parecoxib sodium (20 mg/ml) combinations after the anesthesia induction but before the surgical incision. Placebo is administered 5 minutes after parecoxib sodium administration.
| Study group | Role | What they receive |
|---|---|---|
| OP group | Experimental | Participants in this group will receive oxycodone and parecoxib sodium before surgical incision. Receives: Drug: oxycodone and parecoxib sodium combinations |
| PP group | Placebo comparator | Participants in this group will receive a placebo and parecoxib sodium before surgical incision. Receives: Drug: Placebo and parecoxib sodium combinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral pain scores in the surgical area at 90 days postoperatively.
The pain scores will be assessed by the Numeric Rating Scale (NRS) and Brief Pain Inventory Scale-Short form (BPI-9). The NRS evaluates pain intensity on a 0-10 scale and the scores are grouped as no (NRS 0), mild (NRS 1-4), moderate (NRS 5-7), or severe pain (NRS 8-10). The BPI-9 is a 9-item questionnaire and each item is scored from 0 = no pain to 10 = worst pain. The BPI-9 is used to assess various aspects of pain severity and pain interference.
Measured: 90 days after the surgery
The incidence of moderate to severe visceral pain at 90 days postoperatively.
The incidence will be calculated as the ratio of the number of participants with moderate to severe visceral pain to the number of participants allocated to each group at 90 days after the surgery .
Measured: 90 days after the surgery
Secondary outcomes (6)
Somatic pain scores in the surgical area at 48 hours postoperatively;
The pain scores will be assessed by the NRS and BPI-9 scales as described above.
Measured: 48 hours after the surgery
Visceral pain scores in the surgical area at 48 hours postoperatively;
The pain scores will be assessed by the NRS and BPI-9 scales as described above.
Measured: 48 hours after the surgery
Incidence of moderate to severe visceral pain at 48 hours postoperatively;
The incidence will be calculated as the ratio of the number of participants with moderate to severe visceral pain to the number of participants allocated to each group at 48 hours after the surgery.
Measured: 48 hours after the surgery
Incidence of moderate to severe visceral pain in the surgical area at 30 days postoperatively;
The incidence will be calculated as the ratio of the number of participants with moderate to severe visceral pain to the number of participants allocated to each group at 30 days after the surgery.
Measured: 30 days after the surgery
Incidence of moderate to severe somatic pain in the surgical area at 30 days postoperatively;
The incidence will be calculated as the ratio of the number of participants with moderate to severe somatic pain to the number of participants allocated to each group at 30 days after the surgery.
Measured: 30 days after the surgery
Incidence of moderate to severe somatic pain in the surgical area at 90 days postoperatively.
The incidence will be calculated as the ratio of the number of participants with moderate to severe somatic pain to the number of participants allocated to each group at 90 days after the surgery.
Measured: 90 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ailin Luo
- Sponsor type
- University, hospital or other
- Collaborators
- Jinhua Central Hospital, Minda Hospital of Hubei Minzu University, Taihe Hospital of Traditional Chinese Medicine, Qujing first people's Hospital
- Responsible party
- Sponsor-investigator, Ailin Luo, Tongji Hospital
- Investigators
- Luo Ailin, Principal investigator, Department of Anesthesiology of Tongji hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721988
- Sponsor's protocol ID
- TJ-IRB202411042
- Acronym
- AOPC
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Preventive Analgesia with Oxycodone and Parecoxib Sodium on the Chronification of Acute Pain in Adult Patients Underwent Laparoscopic-assisted Abdominal Major Surgery
- ClinicalTrials.gov ID
- NCT06721988
- Acronym / sponsor ID
- AOPC / TJ-IRB202411042
- Conditions
- Oxycodone, Chronic Pain, Postoperative
- Keywords
- Oxycodone, Preventive analgesia, Chronification of acute postoperative pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,316 participants (estimated)
- Lead sponsor
- Ailin LuoUniversity, hospital or other
- Collaborators
- Jinhua Central Hospital, Minda Hospital of Hubei Minzu University, Taihe Hospital of Traditional Chinese Medicine, Qujing first people's Hospital
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Dec 2024 (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.
The goal of this clinical trial is to learn if the administration of oxycodone for preventive analgesia works to reduce the chronification of acute postoperative pain in adult participants undergoing major abdominal surgery. The main question it aims to answer is:
- Does administration of oxycodone before surgical incision reduce the occurrence of chronic pain or relieve the chronic pain symptoms 3 months after the operation? Researchers will compare oxycodone + parecoxib sodium to placebo + parecoxib sodium combinations to see if oxycodone works to reduce the chronification of acute postoperative pain.
Participants will:
- Take oxycodone + parecoxib sodium or placebo + parecoxib sodium combinations before the surgical incision
- Cooperate with the follow-up staffs and complete some checkups or tests within 3 months after the operation.
Detailed description
Preventive analgesia encompasses a range of analgesic strategies designed to mitigate hyperalgesia and allodynia induced by noxious stimuli by preventing peripheral and intraoperative sensitization to pain. It constitutes a fundamental component of multimodal analgesia. Nonsteroidal anti-inflammatory drugs (NSAIDs) are presently the most frequently employed agents for preventive analgesia, demonstrating efficacy in reducing the incidence of acute postoperative pain and chronic post-surgical pain. However, the management of acute postoperative pain and chronic post-surgical pain remains suboptimal. κ-opioid receptors are regarded as the primary receptors involved in the transmission of visceral pain, and κ-receptor agonists have been shown to effectively inhibit this transmission. Administering κ-receptor agonists via intravenous infusion either before the conclusion of surgery or postoperatively can substantially mitigate pain during the recovery period. This indicates that κ-receptor agonists possess potential as preventive analgesics. However, there is currently a paucity of high-quality clinical evidence supporting their use in preventive analgesia. Oxycodone functions as a dual agonist of μ-opioid and κ-opioid receptors and is extensively utilized in postoperative analgesia and anesthesia induction. Its safety and efficacy in pain management have been thoroughly validated. Theoretically, the concurrent administration of oxycodone and NSAIDs, which mitigate pain signal transmission through distinct mechanisms, could result in an additive preventive analgesic effect. However, there is currently a paucity of high-quality clinical evidence supporting this hypothesis. Consequently, this study seeks to investigate the effects of the combined administration of oxycodone and NSAIDs as preventive analgesia on the transition of acute postoperative pain to chronic pain in patients undergoing major abdominal surgery. The findings aim to contribute clinical evidence and theoretical insights to enhance perioperative pain management strategies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OP group | Experimental | Drug: oxycodone and parecoxib sodium combinationsParticipants in this group will receive oxycodone and parecoxib sodium before surgical incision. |
| PP group | Placebo comparator | Drug: Placebo and parecoxib sodium combinationsParticipants in this group will receive a placebo and parecoxib sodium before surgical incision. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I~III；
- BMI ranging from 18 to 28 kg/m²；
- For elective laparoscopic-assisted major abdominal surgery under general anesthesia;
- Estimated surgical duration (from incision to the last suture of the skin) was at least 2 hours.
Key exclusion criteria (15 listed)
- Pregnant or lactating patients;
- Patients diagnosed with septic shock or multiple organ failure within 14 days;
- Patients with preoperative severe electrolyte disorders;
- Patients with stroke, transient ischemic attack, or other similar events within the past 3 months
- Patients with unstable angina, myocardial infarction within the past 3 months; or presence of untreated arrhythmia or arrhythmia not well-controlled with treatment;
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 and parecoxib sodium combinationsParticipants will receive 0.1ml/kg oxycodone (1mg/ml) and 2 ml parecoxib sodium (20 mg/ml) combinations after the anesthesia induction but before the surgical incision. Oxycodone is administered 5 minutes after parecoxib sodium administration. | Drug | OP group |
| Placebo and parecoxib sodium combinationsParticipants will receive 0.1ml/kg placebo (0.9% saline) and 2 ml parecoxib sodium (20 mg/ml) combinations after the anesthesia induction but before the surgical incision. Placebo is administered 5 minutes after parecoxib sodium administration. | Drug | PP group |
Primary outcome
Visceral pain scores in the surgical area at 90 days postoperatively.
Time frame: 90 days after the surgery
The pain scores will be assessed by the Numeric Rating Scale (NRS) and Brief Pain Inventory Scale-Short form (BPI-9). The NRS evaluates pain intensity on a 0-10 scale and the scores are grouped as no (NRS 0), mild (NRS 1-4), moderate (NRS 5-7), or severe pain (NRS 8-10). The BPI-9 is a 9-item questionnaire and each item is scored from 0 = no pain to 10 = worst pain. The BPI-9 is used to assess various aspects of pain severity and pain interference.
The incidence of moderate to severe visceral pain at 90 days postoperatively.
Time frame: 90 days after the surgery
The incidence will be calculated as the ratio of the number of participants with moderate to severe visceral pain to the number of participants allocated to each group at 90 days after the surgery .
6 secondary outcomes
Somatic pain scores in the surgical area at 48 hours postoperatively;
Time frame: 48 hours after the surgery
Visceral pain scores in the surgical area at 48 hours postoperatively;
Time frame: 48 hours after the surgery
Incidence of moderate to severe visceral pain at 48 hours postoperatively;
Time frame: 48 hours after the surgery
Incidence of moderate to severe visceral pain in the surgical area at 30 days postoperatively;
Time frame: 30 days after the surgery
Incidence of moderate to severe somatic pain in the surgical area at 30 days postoperatively;
Time frame: 30 days after the surgery
Incidence of moderate to severe somatic pain in the surgical area at 90 days postoperatively.
Time frame: 90 days after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Li Shiyong contact
Luo Ailin principal investigator
Department of Anesthesiology of Tongji hospital
Questions about this trial
What is this clinical trial studying?
A study testing oxycodone and parecoxib sodium combinations in people with Oxycodone and Chronic Pain, Postoperative, run by Ailin Luo.
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 15 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: opening soon, as of the sponsor's last update on 9 Dec 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luo Ailin (86-027-83665480, alluo@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visceral pain scores in the surgical area at 90 days postoperatively. (time frame: 90 days after the 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 9 Dec 2024.