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Completed

NCT Number: NCT06411665

Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting

Postoperative nausea and vomiting (PONV) is common after surgery and impede rapid recovery after surgery. Patients who undergo laparoscopic colorectal surgery are more likely to develop PONV due to the pneumoperitoneum, interruption of gastrointestinal system, delay of oral feeding, and nasogastric catheterization, as well as postoperative opioid analgesic requirement to control acute pain. Oliceridine is a novel selective μ-opioid agonist. It stimulates G protein signalling but is markedly less potent than morphine for β-arrestin recruitment; the latter contributes to opioid-related adverse events including PONV. It is postulated that G protein-biased agonists may deliver effective analgesia with fewer opioid-related adverse events. This randomized trial aimed to investigate whether oliceridine for patient-controlled analgesia can decrease the incidence of PONV in patients recovering from laparoscopic colorectal surgery.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dong-Xin Wang

Beijing, 100034, China

About this study

Postoperative nausea and vomiting (PONV) is a common adverse event after surgery. A retrospective study found that PONV occurred in 14.4% of enrolled 106860 patients. The reported incidences in prospective studies varied between 25.5% to 33.3%. Certain types of laparoscopic surgery are associated with an increased risk of PONV, including bariatric surgery, gynecological surgery, and cholecystectomy. PONV can lead to dehydration and electrolyte imbalances, delay early ambulation, impede rapid recovery after surgery, decrease patients' satisfactory, and potentially prolong hospital stay and increase cost.

Opioids are commonly used during the perioperative period and are associated with increased PONV. Conventional opioids such as morphine and sufentanil activate both the G protein and β-arrestin pathways; the latter approach contributes to opioid-related PONV through multiple mechanisms, such as enhanced vestibular sensitivity, direct effects on the chemoreceptor trigger zone, and delayed gastric emptying. Oliceridine is a novel selective μ-opioid agonist. It stimulates G protein signalling but is markedly less potent than morphine for β-arrestin recruitment. It is therefore postulated that G protein-biased agonists may deliver effective analgesia with fewer opioid-related PONV.

Previous studies in patients with moderate-to-severe pain following orthopaedic surgery-bunionectomy or plastic surgery-abdominoplasty showed that oliceridine provided an excellent analgesic efficacy compared with morphine and placebo. The analgesic efficiency of 0.35 mg or 0.5 mg oliceridine was equal to 1 mg morphine. However, the rate of PONV was significantly lower in patients given oliceridine than in those given morphine. Patients who undergo laparoscopic colorectal surgery are more likely to develop PONV due to the pneumoperitoneum, interruption of gastrointestinal system, delay of oral feeding, and nasogastric catheterization, as well as postoperative opioid analgesia to control pain. Thus, selective μ-opioid agonist might be more suitable for postoperative analgesia for these patients.

This randomized trial aimed to investigate whether oliceridine compared with morphine for postoperative analgesia can decrease the incidence of PONV in patients after laparoscopic colorectal surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 80 years;
  • Scheduled to undergo elective laparoscopic colorectal surgery;
  • Required patient-controlled intravenous analgesia.

Exclusion criteria

  • Pregnancy.
  • Severe heart dysfunction (New York Heart Association functional classification 4), hepatic insufficiency (Child-Pugh grade C), renal insufficiency (serum creatinine of 442 μmol/L or above, or requirement of renal replacement therapy), or Amercian Society of Anesthesiologists classification IV or above.
  • Unable to complete preoperative assessment due to severe dementia or language barrier.
  • Other conditions that are considered unsuitable for study participation.

Treatment and study plan

Oliceridine

Drug

Patient-controlled intravenous analgesia with oliceridine for up to 3 days after surgery.

Other names: Oliceridine for injection

Morphine

Drug

Patient-controlled intravenous analgesia with morphine for up to 3 days after surgery.

Other names: Morphine for injection

Primary outcomes

  1. The incidence of postoperative nause and vomiting (PONV) with 72 hours.

    Time frame: Up to 72 hours after surgery.

    Defined as the development of any nausea, retching, or vomiting within 72 h after surgery.

Secondary outcomes

  1. The incidence of postoperative vomiting within 72 hours.

    Time frame: Up to 72 hours after surgery

    Defined as the development of any retching or vomiting within 72 h after surgery.

  2. Area under curve of nausea intensity at predefined timepoints.

    Time frame: Up to 72 hours after surgery

    Nausea intensity is assessed with the numeric rating scale, an 11-point scale where 0=no nausea and 10=the most severe nausea.

  3. Area under curve of pain intensity at rest at predefined timepoints.

    Time frame: Up to 72 hours after surgery

    Pain intensity is assessed with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain.

  4. Area under curve of pain intensity with movement at predefined timepoints

    Time frame: Up to 72 hours after surgery

    Pain intensity is assessed with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain.

  5. Quality of recovery at 24 hours and 72 hours after surgery.

    Time frame: Up to 72 hours after surgery

    Quality of recovery (QoR) is assessed with the QOR-15 scale, a 15-item scale that provides a global measure of postoperative recovery, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR).

  6. Time to first flatus after surgery.

    Time frame: Up to 5 days after surgery.

    Time to first flatus after surgery.

Other outcomes

  1. Time to first ambulation after surgery.

    Time frame: Up to 5 days after surgery.

    Time to first ambulation after surgery.

  2. Patients' satisfaction score with postoperative analgesia.

    Time frame: At 72 hours after surgery.

    Patients' satisfaction is assessed with a visual analogue scale, a 0-100 scale where 0=very dissatisfied and 100=very satisfied.

  3. Total opioid consumption within 72 hours after surgery.

    Time frame: Up to 72 hours after surgery.

    Total opioid consumption within 72 hours after surgery.

  4. Subjective sleep quality during the first 3 nights after surgery.

    Time frame: Up to 72 hours after surgery.

    Subjective sleep quality is assessed with the numeric rating scale, an 11-point scale where 0=the best sleep and 10=the worst sleep.

  5. Length of hospital stay after surgery.

    Time frame: Up to 30 days after surgery.

    Length of hospital stay after surgery.

  6. Major complications within 30 days after surgery.

    Time frame: Up to 30 days after surgery.

    Major complications are defined as new-onset medical events that are deemed harmful and required therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting in Laparoscopic Colorectal Surgery: A Randomized Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 13, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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