Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting

May 11, 2024 updated by: Dong-Xin Wang, Peking University First Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnancy.
  2. 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.
  3. Unable to complete preoperative assessment due to severe dementia or language barrier.
  4. Other conditions that are considered unsuitable for study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oliceridine group
Patient-controlled analgesia pump is provided immediately after surgery. The pump is established with oliceridine 15 mg, diluted with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a 10-min lockout interval and a background infusion rate at 1 ml/h. The pump will be used during the first 3 days after surgery.
Drug: Oliceridine
Patient-controlled intravenous analgesia with oliceridine for up to 3 days after surgery.
Other Names:
  • Oliceridine for injection
Active Comparator: Morphine group
Patient-controlled analgesia pump is provided immediately after surgery. The pump is established with morphine 50 mg, diluted with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a 10-min lockout interval and a background infusion rate at 1 ml/h. The pump will be used during the first 3 days after surgery.
Drug: Morphine
Patient-controlled intravenous analgesia with morphine for up to 3 days after surgery.
Other Names:
  • Morphine for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 72 hours after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 72 hours after surgery
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.
Up to 72 hours after surgery
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.
Up to 72 hours after surgery
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).
Up to 72 hours after surgery
Time to first flatus after surgery.
Time Frame: Up to 5 days after surgery.
Time to first flatus after surgery.
Up to 5 days after surgery.
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.
Up to 72 hours after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay after surgery.
Time Frame: Up to 30 days after surgery.
Length of hospital stay after surgery.
Up to 30 days after surgery.
Time to first ambulation after surgery.
Time Frame: Up to 5 days after surgery.
Time to first ambulation after surgery.
Up to 5 days after surgery.
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.
At 72 hours after surgery.
Total opioid consumption within 72 hours after surgery.
Time Frame: Up to 72 hours after surgery.
Total opioid consumption within 72 hours after surgery.
Up to 72 hours after surgery.
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.
Up to 72 hours after surgery.
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.
Up to 30 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Study Director: Dong-Xin Wang, PHD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Nausea and Vomiting

Clinical Trials on Oliceridine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe