Postoperative HyperalgesiaPhase 4NCT07913555
Oliceridine for Remifentanil-Induced Postoperative Hyperalgesia
A Phase 4 study testing Oliceridine and sufentanil in people with Postoperative Hyperalgesia, run by Xingguo Xu at 1 site in China.
Trial summary
Objective: To investigate the effect of oliceridine on remifentanil-induced postoperative hyperalgesia and to observe its effects on postoperative pain scores, quality of recovery, and adverse reactions.Methods: A total of 130 patients undergoing gynecological laparoscopic surgery under general anesthesia were… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Postoperative Hyperalgesia
- What is being tested?
- Oliceridine and sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 Sep 2026
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective gynecological laparoscopic surgery
- Normal cognitive function and able to complete postoperative pain assessments and use the postoperative analgesia device.
Who cannot join
- Severe cardiovascular, cerebrovascular, hepatic, or renal diseases, or other systemic diseases
- Psychiatric disorders or long-term use of psychotropic drugs
- History of chronic analgesic use or alcohol abuse
- Use of analgesics within 48 h before surgery
- Allergy to opioids or contraindications to opioid use
- Speech or hearing impairment, or inability to complete pain assessments
- Conversion to laparotomy or operative time < 2 h during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To investigate the effect of oliceridine on remifentanil-induced postoperative hyperalgesia and to observe its effects on postoperative pain scores, quality of recovery, and adverse reactions.Methods: A total of 130 patients undergoing gynecological laparoscopic surgery under general anesthesia were enrolled and randomly assigned to either the oliceridine group (Group O) or the sufentanil group (Group S), with 65 patients in each group. Remifentanil was used for anesthesia maintenance in both groups. Before skin closure, patients received either 0.02 mg/kg oliceridine (Group O) or 0.1 μg/kg sufentanil (Group S) via intravenous injection. The primary outcome measure was the mechanical pain threshold around the incision at 6 h postoperatively. Secondary outcome measures included mechanical pain thresholds around the incision and on the non-dominant forearm at 30 min, 6 h, 24 h, and 48 h postoperatively; Numeric Rating Scale (NRS) pain scores; number of effective patient-controlled analgesia (PCA) compressions; incidence of rescue analgesia; 24 h postoperative Quality of Recovery-15 (QoR-15) score; extubation time; post-anesthesia care unit (PACU) stay duration; and incidence of adverse reactions within 48 h postoperatively.
- Conditions
- Postoperative Hyperalgesia
- Being tested
- Oliceridine, sufentanil
- Keywords
- oliceridine, remifentanil, postoperative hyperalgesia, gynecological laparoscopic surgery, Quality of Recovery-15 (QoR-15)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
Patients in the oliceridine group were administered 0.02 mg/kg oliceridine intravenously before skin closure
sufentanilDrug
Patients in the sufentanil group were administered 0.02 mg/kg sufentanil intravenously before skin closure,
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine Group | Experimental | Anesthesia was induced with remimazolam, sufentanil, etomidate, and vecuronium bromide. Anesthesia was maintained with continuous infusion of propofol and remifentanil, combined with inhaled sevoflurane.Patients in the oliceridine group were administered 0.02 mg/kg oliceridine intravenously before skin closure Receives: Drug: Oliceridine |
| Sufentanil Group | Active comparator | Anesthesia was induced with remimazolam, sufentanil, etomidate, and vecuronium bromide. Anesthesia was maintained with continuous infusion of propofol and remifentanil, combined with inhaled sevoflurane.Patients in the sufentanil group were administered 0.1 μg/kg sufentanil intravenously before skin cl Receives: Drug: sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical pain threshold around the incision at 6 hours post-surgery
Mechanical pain thresholds around the surgical incision were measured using a von Frey tactile esthesiometer kit.
Measured: 6 hours post-surgery
Secondary outcomes (16)
Mechanical pain threshold around the incision
Measurements around the incision were taken at the midpoint of the incision and at 5 cm from each end of the incision, and the mean value of all measurement points was calculated.
Measured: Preoperatively,at 30 minutes post-surgery, at 24 hours post-surgery, at 48 hours post-surgery
Mechanical pain threshold on the non-dominant forearm
Measurements on the non-dominant forearm were taken at 3, 6, and 9 cm from the antecubital crease, and the mean of the three values was calculated.
Measured: Preoperatively, at 30 minutes post-surgery, at 6 hours post-surgery, at 24 hours post-surgery, at 48 hours post-surgery
Operative time
Measured: Intraoperatively
Extubation time
Extubation time, defined as the time from the end of surgery to tracheal extubation
Measured: From the end of surgery until tracheal extubation, assessed for up to 2 hours postoperatively
PACU stay duration
PACU stay duration, defined as the time from PACU admission to PACU discharge
Measured: From PACU admission until PACU discharge, assessed for up to 4 hours after PACU admission
Intraoperative propofol consumption
Measured: Intraoperatively
Intraoperative remifentanil consumption
Measured: Intraoperatively
Number of patients receiving atropine
Measured: Intraoperatively
Number of patients receiving vasopressors
Measured: Intraoperatively
MAP
Mean arterial pressure (MAP)
Measured: Preoperatively (baseline), 1 minute after skin closure , at tracheal extubation, immediately before leaving the operating room
HR
heart rate (HR)
Measured: Preoperatively (baseline), 1 minute after skin closure , at tracheal extubation, immediately before leaving the operating room
Numeric Rating Scale (NRS) score
Numeric Rating Scale (NRS) for pain score ranging from 0 to 10; higher scores indicate worse pain.
Measured: at 30 minutes post-surgery, at 6 hours post-surgery, at 24 hours post-surgery, at 48 hours post-surgery
Number of effective PCA compressions
Measured: From end of surgery to 48 hours post-surgery
Number of patients requiring rescue analgesia
Measured: From end of surgery to 48 hours post-surgery
Quality of Recovery-15 (QoR-15)
Quality of Recovery-15 (QoR-15) questionnaire score ranging from 0 to 150 (15 items, each scored 0-10); higher scores indicate better quality of postoperative recovery.
Measured: at 24 hours post-surgery
Incidence of adverse reactions
ncidence of adverse reactions: The occurrence of adverse events including hypotension, bradycardia, shivering, postoperative nausea and vomiting (PONV), dizziness, drowsiness, respiratory depression, and pruritus within 48 h postoperatively was recorded.
Measured: From end of surgery to 48 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 May 2026
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HyperalgesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xingguo Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xingguo Xu, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913555
- Sponsor's protocol ID
- 2026-K009
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision on sharing individual participant data has not yet been made. The study team will review participant consent and institutional requirements before determining whether and how de-identified data can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oliceridine for Remifentanil-Induced Postoperative Hyperalgesia
- ClinicalTrials.gov ID
- NCT07913555
- Acronym / sponsor ID
- 2026-K009
- Conditions
- Postoperative Hyperalgesia
- Keywords
- oliceridine, remifentanil, postoperative hyperalgesia, gynecological laparoscopic surgery, Quality of Recovery-15 (QoR-15)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Xingguo XuUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 3 Nov 2026 (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.
Objective: To investigate the effect of oliceridine on remifentanil-induced postoperative hyperalgesia and to observe its effects on postoperative pain scores, quality of recovery, and adverse reactions.Methods: A total of 130 patients undergoing gynecological laparoscopic surgery under general anesthesia were enrolled and randomly assigned to either the oliceridine group (Group O) or the sufentanil group (Group S), with 65 patients in each group. Remifentanil was used for anesthesia maintenance in both groups. Before skin closure, patients received either 0.02 mg/kg oliceridine (Group O) or 0.1 μg/kg sufentanil (Group S) via intravenous injection. The primary outcome measure was the mechanical pain threshold around the incision at 6 h postoperatively. Secondary outcome measures included mechanical pain thresholds around the incision and on the non-dominant forearm at 30 min, 6 h, 24 h, and 48 h postoperatively; Numeric Rating Scale (NRS) pain scores; number of effective patient-controlled analgesia (PCA) compressions; incidence of rescue analgesia; 24 h postoperative Quality of Recovery-15 (QoR-15) score; extubation time; post-anesthesia care unit (PACU) stay duration; and incidence of adverse reactions within 48 h postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oliceridine Group | Experimental | Drug: OliceridineAnesthesia was induced with remimazolam, sufentanil, etomidate, and vecuronium bromide. Anesthesia was maintained with continuous infusion of propofol and remifentanil, combined with inhaled sevoflurane.Patients in the oliceridine group were administered 0.02 mg/kg oliceridine intravenously before skin closure |
| Sufentanil Group | Active comparator | Drug: sufentanilAnesthesia was induced with remimazolam, sufentanil, etomidate, and vecuronium bromide. Anesthesia was maintained with continuous infusion of propofol and remifentanil, combined with inhaled sevoflurane.Patients in the sufentanil group were administered 0.1 μg/kg sufentanil intravenously before skin cl |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-75 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective gynecological laparoscopic surgery
- Normal cognitive function and able to complete postoperative pain assessments and use the postoperative analgesia device.
Key exclusion criteria (7 listed)
- Severe cardiovascular, cerebrovascular, hepatic, or renal diseases, or other systemic diseases
- Psychiatric disorders or long-term use of psychotropic drugs
- History of chronic analgesic use or alcohol abuse
- Use of analgesics within 48 h before surgery
- Allergy to opioids or contraindications to opioid use
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 |
|---|---|---|
| OliceridinePatients in the oliceridine group were administered 0.02 mg/kg oliceridine intravenously before skin closure | Drug | Oliceridine Group |
| sufentanilPatients in the sufentanil group were administered 0.02 mg/kg sufentanil intravenously before skin closure, | Drug | Sufentanil Group |
Primary outcome
Mechanical pain threshold around the incision at 6 hours post-surgery
Time frame: 6 hours post-surgery
Mechanical pain thresholds around the surgical incision were measured using a von Frey tactile esthesiometer kit.
16 secondary outcomes
Mechanical pain threshold around the incision
Time frame: Preoperatively,at 30 minutes post-surgery, at 24 hours post-surgery, at 48 hours post-surgery
Mechanical pain threshold on the non-dominant forearm
Time frame: Preoperatively, at 30 minutes post-surgery, at 6 hours post-surgery, at 24 hours post-surgery, at 48 hours post-surgery
Operative time
Time frame: Intraoperatively
Extubation time
Time frame: From the end of surgery until tracheal extubation, assessed for up to 2 hours postoperatively
PACU stay duration
Time frame: From PACU admission until PACU discharge, assessed for up to 4 hours after PACU admission
Intraoperative propofol consumption
Time frame: Intraoperatively
Intraoperative remifentanil consumption
Time frame: Intraoperatively
Number of patients receiving atropine
Time frame: Intraoperatively
Number of patients receiving vasopressors
Time frame: Intraoperatively
MAP
Time frame: Preoperatively (baseline), 1 minute after skin closure , at tracheal extubation, immediately before leaving the operating room
HR
Time frame: Preoperatively (baseline), 1 minute after skin closure , at tracheal extubation, immediately before leaving the operating room
Numeric Rating Scale (NRS) score
Time frame: at 30 minutes post-surgery, at 6 hours post-surgery, at 24 hours post-surgery, at 48 hours post-surgery
Number of effective PCA compressions
Time frame: From end of surgery to 48 hours post-surgery
Number of patients requiring rescue analgesia
Time frame: From end of surgery to 48 hours post-surgery
Quality of Recovery-15 (QoR-15)
Time frame: at 24 hours post-surgery
Incidence of adverse reactions
Time frame: From end of surgery to 48 hours post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided. A decision on sharing individual participant data has not yet been made. The study team will review participant consent and institutional requirements before determining whether and how de-identified data can be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oliceridine and sufentanil in people with Postoperative Hyperalgesia, run by Xingguo Xu 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 3 Nov 2026. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical pain threshold around the incision at 6 hours post-surgery (time frame: 6 hours post-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 Nov 2026.