A Phase 4 interventional study of Oliceridine and sufentanil in Postoperative Hyperalgesia, sponsored by Xingguo Xu. Completed at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Xingguo Xu · Phase 4, Interventional, and Prevention
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.
166 studies on the registry are indexed under Hyperalgesia; 14 are open to participants now.
This study's enrollment of 130 is above the median of 50 across 142 interventional studies indexed under Hyperalgesia.
Browse Hyperalgesia studies →Xingguo Xu is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Oliceridine
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
Drug: sufentanil
Patients in the oliceridine group were administered 0.02 mg/kg oliceridine intravenously before skin closure
Patients in the sufentanil group were administered 0.02 mg/kg sufentanil intravenously before skin closure,
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.
Time frame: 6 hours post-surgery
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.
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
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.
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
Extubation time, defined as the time from the end of surgery to tracheal extubation
Time frame: 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
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
Mean arterial pressure (MAP)
Time frame: Preoperatively (baseline), 1 minute after skin closure , at tracheal extubation, immediately before leaving the operating room
HR
heart rate (HR)
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: From end of surgery to 48 hours post-surgery
Plan to share: 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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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oliceridine