Postoperative AnalgesiaNCT06409689
Oliceridine-Enhanced Analgesia and Recovery: A G-Protein Biased μ-Opioid Study
A study testing Oliceridine fumarate low dose, Oliceridine fumarate high dose and Oliceridine fumarate moderate dose in people with Postoperative Analgesia, run by Tongji Hospital at 1 site in China.
Trial summary
Identifying the lowest effective opioid dose that achieves rapid pain relief while minimizing side effects is a principal objective in postoperative multimodal analgesia strategies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Oliceridine fumarate low dose, Oliceridine fumarate high dose and Oliceridine fumarate moderate dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Jul 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA grades 1-2
- Age > 18 years and < 70 years
- Laparoscopic upper abdominal surgery under general anesthesia is planned, and the operation time is not more than 4 hours
- Voluntarily receive postoperative controlled intravenous analgesia
- Subjects understand and can cooperate with this study
- Subjects can provide and sign written informed consent prior to conducting investigation-related screening procedures
Who cannot join
- BMI>30 kg/m2 or < 19 kg/m2
- Patients with preoperative use of opioids, acute and chronic pain or hyperalgesia
- Patients with coronary atherosclerotic heart disease, significant ischemic heart disease, severe angina, heart failure, valvular disease or other heart disease
- More severe hepatic and renal insufficiency
- A history of mental illness or alcoholism
- A history of alcohol or drug abuse
Show all 14Show fewer
- Combined with cranial pressure, intraocular pressure or glaucoma
- Poorly controlled or untreated hypertension before surgery
- Preeclampsia or eclampsia
- Untreated and undertreated hyperthyroidism
- Combined with autoimmune disease
- Unable to use the numerical rating scale
- History of chronic cough
- Surgery is expected to take more than 4 hours Patients enrolled in other clinical trials within 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei
Hui Xu, +8613971001596, huixu@tjh.tjmu.edu.cn
About this study
Official title: Enhanced Postoperative Analgesia and Accelerated Recovery With Oliceridine: A Study on G-Protein Biased μ-Opioid Agonist
Identifying the lowest effective opioid dose that achieves rapid pain relief while minimizing side effects is a principal objective in postoperative multimodal analgesia strategies. This study aims to determine the optimal analgesic regimen and dosage by assessing the clinical efficacy of oliceridine for postoperative pain management. It also evaluates oliceridine's contribution to accelerated postoperative recovery, examining aspects such as postoperative pulmonary complications, gastrointestinal function, nausea and vomiting, cognitive function, and emotional distress. Furthermore, the study integrates microbiomics and metabolomics to investigate the underlying molecular mechanisms by which oliceridine promotes rapid postoperative recovery. This research will broaden the clinical data and potential applications of oliceridine, addressing gaps in the field and enhancing practical knowledge. Moreover, this is the first time a clinical study combining multiple omics approaches will provide a comprehensive theoretical foundation for its clinical benefits.
Read the detailed description
This study selects 80 elective patients slated for upper abdominal laparoscopic surgery under general anesthesia, classified as ASA I-II. These patients are randomly allocated into four groups: Oliceridine low dose (OⅠ), medium dose (OⅡ), and high dose (OⅢ), and a Morphine (M) group. The postoperative analgesic protocol includes a universal loading dose of 1.5 mg for all groups. Depending on the group, the PCA doses are set at 0.1 mg, 0.35 mg, or 0.5 mg, with a lockout interval of 6 minutes. After the initial dose, patients may receive an additional 0.75 mg per hour as needed, with a daily ceiling of 27 mg for Oliceridine. In the Morphine group, the loading dose is 4 mg with a PCA dose of 1 mg and similar lockout, allowing 2 mg per hour post-loading, capped at 60 mg daily. Outcomes to monitor include systolic and diastolic blood pressures, heart rate, oxygen saturation, and respiratory rate at 6, 24, and 48 hours postoperatively; pain levels using the NRS scale; nausea and vomiting via the VAS score; and pulmonary complications evaluated by EPCO standards at specified intervals. Gastrointestinal function is assessed using the I-FEED score, and mental health through the HADS scale preoperatively and 48 hours post-surgery. Cognitive function is evaluated using the MMSE scale preoperatively and 72 hours postoperatively. Patient fecal samples are collected pre- and 48 hours post-surgery for microbial and metabolomic analyses to identify potential molecular benefits of Oliceridine, informed by its G-protein biased pharmacology. The study also uses statistical methods to compare microbiological outcomes and correlate these with clinical presentations.
- Conditions
- Postoperative Analgesia
- Being tested
- Oliceridine fumarate low dose, Oliceridine fumarate high dose, Oliceridine fumarate moderate dose, morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oliceridine fumarate low doseDrug
The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.1 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose
Oliceridine fumarate high doseDrug
The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.5 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose
Oliceridine fumarate moderate doseDrug
The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.35 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose
morphineDrug
The first loading dose of morphine was 4 mg in all patients after operation. The PCA dose of the patients was 1 mg, and the locking interval was 6 min. A supplemental dose of 2 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 60 mg.
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine fumarate low dose group | Experimental | The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.1 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 27mg. The duration of PCA analgesia was 48 hours. Receives: Drug: Oliceridine fumarate low dose |
| Oliceridine fumarate medium dose group | Experimental | The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.35mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 27mg. The duration of PCA analgesia was 48 hours. Receives: Drug: Oliceridine fumarate moderate dose |
| Oliceridine fumarate high dose group | Experimental | The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.5 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 27mg. The duration of PCA analgesia was 48 hours. Receives: Drug: Oliceridine fumarate high dose |
| Morphine group | Experimental | The first loading dose of morphine was 4 mg in all patients after operation. The PCA dose of the patients was 1 mg, and the locking interval was 6 min. A supplemental dose of 2 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 60 mg. The duration of PCA analgesia was 48 hours. Receives: Drug: morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score
The NRS Numerical Pain Evaluation Scale assessed postoperative pain status: no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).
Measured: 6 hour, 24hour, and 48 hour after surgery
Secondary outcomes (4)
Postoperative nausea and vomiting
With a 10cm ruler as the scale, 0 at one end indicates no nausea and vomiting, and 10 at the other end indicates the most severe nausea and vomiting that is unbearable. 1 to 4 is mild, 5 to 6 is moderate, 7 to 10 is severe
Measured: 6 hour, 24 hour, and 48 hour after surgery
Postoperative pulmonary complications
european perioperative clinical outcome (EPCO)
Measured: 24 hour,72 hour after surgery
Postoperative cognitive function
(mini-mental state examination, MMSE) scale score，The maximum score is 30 points. The classification of dementia is related to the level of education, so if the elderly are illiterate and less than 17 points, primary school and less than 20 points, secondary school and above less than 24 points, then dementia.
Measured: Before surgery, 3 days after surgery
Flora abundance
Feces were collected from patients before surgery and 48 hours after surgery (stored at negative 80 degrees), and the fecal intestinal flora abundance of patients in each group was determined by 16S rRNA omics
Measured: One day before surgery and 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 posted10 May 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Tongji 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Xu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409689
- Sponsor's protocol ID
- S058
- Status last verified
- Jan 2025
- First submitted
- 7 May 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Postoperative Analgesia and Accelerated Recovery With Oliceridine: A Study on G-Protein Biased μ-Opioid Agonist
- ClinicalTrials.gov ID
- NCT06409689
- Acronym / sponsor ID
- S058
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 10 May 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.
Identifying the lowest effective opioid dose that achieves rapid pain relief while minimizing side effects is a principal objective in postoperative multimodal analgesia strategies. This study aims to determine the optimal analgesic regimen and dosage by assessing the clinical efficacy of oliceridine for postoperative pain management. It also evaluates oliceridine's contribution to accelerated postoperative recovery, examining aspects such as postoperative pulmonary complications, gastrointestinal function, nausea and vomiting, cognitive function, and emotional distress. Furthermore, the study integrates microbiomics and metabolomics to investigate the underlying molecular mechanisms by which oliceridine promotes rapid postoperative recovery. This research will broaden the clinical data and potential applications of oliceridine, addressing gaps in the field and enhancing practical knowledge. Moreover, this is the first time a clinical study combining multiple omics approaches will provide a comprehensive theoretical foundation for its clinical benefits.
Detailed description
This study selects 80 elective patients slated for upper abdominal laparoscopic surgery under general anesthesia, classified as ASA I-II. These patients are randomly allocated into four groups: Oliceridine low dose (OⅠ), medium dose (OⅡ), and high dose (OⅢ), and a Morphine (M) group. The postoperative analgesic protocol includes a universal loading dose of 1.5 mg for all groups. Depending on the group, the PCA doses are set at 0.1 mg, 0.35 mg, or 0.5 mg, with a lockout interval of 6 minutes. After the initial dose, patients may receive an additional 0.75 mg per hour as needed, with a daily ceiling of 27 mg for Oliceridine. In the Morphine group, the loading dose is 4 mg with a PCA dose of 1 mg and similar lockout, allowing 2 mg per hour post-loading, capped at 60 mg daily. Outcomes to monitor include systolic and diastolic blood pressures, heart rate, oxygen saturation, and respiratory rate at 6, 24, and 48 hours postoperatively; pain levels using the NRS scale; nausea and vomiting via the VAS score; and pulmonary complications evaluated by EPCO standards at specified intervals. Gastrointestinal function is assessed using the I-FEED score, and mental health through the HADS scale preoperatively and 48 hours post-surgery. Cognitive function is evaluated using the MMSE scale preoperatively and 72 hours postoperatively. Patient fecal samples are collected pre- and 48 hours post-surgery for microbial and metabolomic analyses to identify potential molecular benefits of Oliceridine, informed by its G-protein biased pharmacology. The study also uses statistical methods to compare microbiological outcomes and correlate these with clinical presentations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oliceridine fumarate low dose group | Experimental | Drug: Oliceridine fumarate low doseThe first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.1 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 27mg. The duration of PCA analgesia was 48 hours. |
| Oliceridine fumarate medium dose group | Experimental | Drug: Oliceridine fumarate moderate doseThe first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.35mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 27mg. The duration of PCA analgesia was 48 hours. |
| Oliceridine fumarate high dose group | Experimental | Drug: Oliceridine fumarate high doseThe first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.5 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 27mg. The duration of PCA analgesia was 48 hours. |
| Morphine group | Experimental | Drug: morphineThe first loading dose of morphine was 4 mg in all patients after operation. The PCA dose of the patients was 1 mg, and the locking interval was 6 min. A supplemental dose of 2 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 60 mg. The duration of PCA analgesia was 48 hours. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA grades 1-2
- Age > 18 years and < 70 years
- Laparoscopic upper abdominal surgery under general anesthesia is planned, and the operation time is not more than 4 hours
- Voluntarily receive postoperative controlled intravenous analgesia
- Subjects understand and can cooperate with this study
Key exclusion criteria (14 listed)
- BMI>30 kg/m2 or < 19 kg/m2
- Patients with preoperative use of opioids, acute and chronic pain or hyperalgesia
- Patients with coronary atherosclerotic heart disease, significant ischemic heart disease, severe angina, heart failure, valvular disease or other heart disease
- More severe hepatic and renal insufficiency
- A history of mental illness or alcoholism
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 |
|---|---|---|
| Oliceridine fumarate low doseThe first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.1 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose | Drug | Oliceridine fumarate low dose group |
| Oliceridine fumarate high doseThe first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.5 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose | Drug | Oliceridine fumarate high dose group |
| Oliceridine fumarate moderate doseThe first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.35 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose | Drug | Oliceridine fumarate medium dose group |
| morphineThe first loading dose of morphine was 4 mg in all patients after operation. The PCA dose of the patients was 1 mg, and the locking interval was 6 min. A supplemental dose of 2 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 60 mg. | Drug | Morphine group |
Primary outcome
postoperative pain score
Time frame: 6 hour, 24hour, and 48 hour after surgery
The NRS Numerical Pain Evaluation Scale assessed postoperative pain status: no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).
4 secondary outcomes
Postoperative nausea and vomiting
Time frame: 6 hour, 24 hour, and 48 hour after surgery
Postoperative pulmonary complications
Time frame: 24 hour,72 hour after surgery
Postoperative cognitive function
Time frame: Before surgery, 3 days after surgery
Flora abundance
Time frame: One day before surgery and 48 hours after 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 3 Jan 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oliceridine fumarate low dose, Oliceridine fumarate high dose and Oliceridine fumarate moderate dose in people with Postoperative Analgesia, run by Tongji Hospital 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 6 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 3 Jan 2025. 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?
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 Hui Xu (+8613971001596, huixu@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain score (time frame: 6 hour, 24hour, and 48 hour 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 3 Jan 2025.