Rebound PainNCT06382896
Effect of Oliceridine on Rebound Pain
An observational study of Rebound Pain and Arthroscopic Knee Surgery, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
The purpose of this clinical study was to identify the risk factors for postoperative pain outburst in patients undergoing arthroscopic knee surgery after Oliceridine and nerve block, and to evaluate the effect of oxeridine on early rehabilitation exercise in patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rebound Pain, Arthroscopic Knee Surgery, Oliceridine
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General anesthesia combined with femoral nerve block was selected for knee arthroscopic day surgery
Who may be able to join
- 1. Age 18-70 years old;2. Body mass index (BMI) 18-30kg /m2;3. American Society of Anesthesiologists (ASA) Grade I to II;4. Hospital stay >24h.
Who cannot join
- 1. Patients who cannot understand the numerical rating scale score and give feedback;2. Known allergy to the drug in the study;3. Infection of puncture site with nerve block;4. Oral analgesics for more than 2 weeks before surgery;5. Long-term use of glucocorticoids;6. Simultaneous surgery on both limbs;7. A psychopath;8. Severe compound trauma;9. Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Bin Yang, doctor, 13859986036, yangbin4332@outlook.com
About this study
Official title: A Clinical Study on the Effect of Oliceridine（TRV130） on Postoperative Rebound Pain and Early Rehabilitation Exercise After Knee Arthroscopy
The purpose of this clinical study was to identify the risk factors for postoperative pain outburst in patients undergoing arthroscopic knee surgery after Oliceridine and nerve block, and to evaluate the effect of oxeridine on early rehabilitation exercise in patients. A total of 320 patients undergoing arthroscopic knee arthroscopy under general anesthesia combined with femoral nerve block were selected to record the time and duration of postoperative pain outbreak, pain degree, age, gender, operation type, previous surgical history and other related risk factors.
- Conditions
- Rebound Pain, Arthroscopic Knee Surgery, Oliceridine
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This was an observational study
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing ambulatory arthroscopic knee surgery | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of onset of postoperative rebound pain
The numerical rating scale was used
Measured: Within 48 hours after surgery
The duration of the rebound pain
The numerical rating scale was used
Measured: Within 48 hours after surgery
The degree of the rebound pain
The numerical rating scale was used
Measured: Within 48 hours after surgery
age
Fill in the postoperative questionnaire
Measured: Within 48 hours after surgery
sex
Fill in the postoperative questionnaire
Measured: Within 48 hours after surgery
Surgical procedure
Fill in the postoperative questionnaire
Measured: Within 48 hours after surgery
Previous surgical history
Fill in the postoperative questionnaire
Measured: Within 48 hours after surgery
Secondary outcomes (1)
Movement recovery time
Fill in the postoperative questionnaire
Measured: Within 7 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rebound PainStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Bin, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382896
- Sponsor's protocol ID
- FirstAHXiamenU-YB-2
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Effect of Oliceridine（TRV130） on Postoperative Rebound Pain and Early Rehabilitation Exercise After Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT06382896
- Acronym / sponsor ID
- FirstAHXiamenU-YB-2
- Conditions
- Rebound Pain, Arthroscopic Knee Surgery, Oliceridine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Apr 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 purpose of this clinical study was to identify the risk factors for postoperative pain outburst in patients undergoing arthroscopic knee surgery after Oliceridine and nerve block, and to evaluate the effect of oxeridine on early rehabilitation exercise in patients. A total of 320 patients undergoing arthroscopic knee arthroscopy under general anesthesia combined with femoral nerve block were selected to record the time and duration of postoperative pain outbreak, pain degree, age, gender, operation type, previous surgical history and other related risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing ambulatory arthroscopic knee surgery | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General anesthesia combined with femoral nerve block was selected for knee arthroscopic day surgery
Key inclusion criteria (1 listed)
- 1. Age 18-70 years old;2. Body mass index (BMI) 18-30kg /m2;3. American Society of Anesthesiologists (ASA) Grade I to II;4. Hospital stay >24h.
Key exclusion criteria (1 listed)
- 1. Patients who cannot understand the numerical rating scale score and give feedback;2. Known allergy to the drug in the study;3. Infection of puncture site with nerve block;4. Oral analgesics for more than 2 weeks before surgery;5. Long-term use of glucocorticoids;6. Simultaneous surgery on both limbs;7. A psychopath;8. Severe compound trauma;9. Pregnant and lactating women.
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 |
|---|---|---|
| No interventionThis was an observational study | Other | Patients undergoing ambulatory arthroscopic knee surgery |
Primary outcome
Time of onset of postoperative rebound pain
Time frame: Within 48 hours after surgery
The numerical rating scale was used
The duration of the rebound pain
Time frame: Within 48 hours after surgery
The numerical rating scale was used
The degree of the rebound pain
Time frame: Within 48 hours after surgery
The numerical rating scale was used
age
Time frame: Within 48 hours after surgery
Fill in the postoperative questionnaire
sex
Time frame: Within 48 hours after surgery
Fill in the postoperative questionnaire
Surgical procedure
Time frame: Within 48 hours after surgery
Fill in the postoperative questionnaire
Previous surgical history
Time frame: Within 48 hours after surgery
Fill in the postoperative questionnaire
1 secondary outcome
Movement recovery time
Time frame: Within 7 days of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rebound Pain and Arthroscopic Knee Surgery, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
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 1 inclusion and 1 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 Apr 2024. 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 China. 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.
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 Bin Yang, doctor (13859986036, yangbin4332@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of onset of postoperative rebound pain (time frame: Within 48 hours after surgery). The study lists 7 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 Apr 2024.