Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting

NCT06411665 | Recruiting Phase 4

• 1 other identifier: 2024-073
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative nausea and vomiting; Laparoscopic colorectal surgery; Postoperative analgesia; Oliceridine

Outcome Measures

Primary Outcomes (1)

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

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

  Up to 72 hours after surgery.

Secondary Outcomes (6)

• The incidence of postoperative vomiting within 72 hours.

  Up to 72 hours after surgery

• Area under curve of nausea intensity at predefined timepoints.

  Up to 72 hours after surgery

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

  Up to 72 hours after surgery

• Area under curve of pain intensity with movement at predefined timepoints

  Up to 72 hours after surgery

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

  Up to 72 hours after surgery

Other Outcomes (6)

• Time to first ambulation after surgery.

  Up to 5 days after surgery.

• Patients' satisfaction score with postoperative analgesia.

  At 72 hours after surgery.

• Total opioid consumption within 72 hours after surgery.

  Up to 72 hours after surgery.

Study Arms (2)

Oliceridine group

EXPERIMENTAL

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

Morphine group

ACTIVE COMPARATOR

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

Interventions

Oliceridine DRUG

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

Also known as: Oliceridine for injection

Oliceridine group

Morphine DRUG

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

Also known as: Morphine for injection

Morphine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Dong-Xin Wang

Beijing, 100034, China

RECRUITING

Related Publications (19)

• Kim JH, Cheon BR, Kim MG, Hwang SM, Lim SY, Lee JJ, Kwon YS. Postoperative Nausea and Vomiting Prediction: Machine Learning Insights from a Comprehensive Analysis of Perioperative Data. Bioengineering (Basel). 2023 Oct 1;10(10):1152. doi: 10.3390/bioengineering10101152.

  PMID: 37892882 RESULT

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  PMID: 37629444 RESULT

• DREAMS Trial Collaborators and West Midlands Research Collaborative. Dexamethasone versus standard treatment for postoperative nausea and vomiting in gastrointestinal surgery: randomised controlled trial (DREAMS Trial). BMJ. 2017 Apr 18;357:j1455. doi: 10.1136/bmj.j1455.

  PMID: 28420629 RESULT

• Song Y, Zhu J, Dong Z, Wang C, Xiao J, Yang W. Incidence and risk factors of postoperative nausea and vomiting following laparoscopic sleeve gastrectomy and its relationship with Helicobacter pylori: A propensity score matching analysis. Front Endocrinol (Lausanne). 2023 Feb 22;14:1102017. doi: 10.3389/fendo.2023.1102017. eCollection 2023.

  PMID: 36909334 RESULT

• Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10. doi: 10.1093/oxfordjournals.bja.a013383.

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  PMID: 30426190 RESULT

• Suh S, Helm M, Kindel TL, Goldblatt MI, Gould JC, Higgins RM. The impact of nausea on post-operative outcomes in bariatric surgery patients. Surg Endosc. 2020 Jul;34(7):3085-3091. doi: 10.1007/s00464-019-07058-5. Epub 2019 Aug 6.

  PMID: 31388805 RESULT

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  PMID: 16846542 RESULT

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  PMID: 32467512 RESULT

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  PMID: 31567573 RESULT

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  PMID: 37556070 RESULT

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  PMID: 24157979 RESULT

• DeWire SM, Yamashita DS, Rominger DH, Liu G, Cowan CL, Graczyk TM, Chen XT, Pitis PM, Gotchev D, Yuan C, Koblish M, Lark MW, Violin JD. A G protein-biased ligand at the mu-opioid receptor is potently analgesic with reduced gastrointestinal and respiratory dysfunction compared with morphine. J Pharmacol Exp Ther. 2013 Mar;344(3):708-17. doi: 10.1124/jpet.112.201616. Epub 2013 Jan 8.

  PMID: 23300227 RESULT

• Markham A. Oliceridine: First Approval. Drugs. 2020 Nov;80(16):1739-1744. doi: 10.1007/s40265-020-01414-9.

  PMID: 33025536 RESULT

• Singla NK, Skobieranda F, Soergel DG, Salamea M, Burt DA, Demitrack MA, Viscusi ER. APOLLO-2: A Randomized, Placebo and Active-Controlled Phase III Study Investigating Oliceridine (TRV130), a G Protein-Biased Ligand at the mu-Opioid Receptor, for Management of Moderate to Severe Acute Pain Following Abdominoplasty. Pain Pract. 2019 Sep;19(7):715-731. doi: 10.1111/papr.12801. Epub 2019 Jun 24.

  PMID: 31162798 RESULT

• Viscusi ER, Skobieranda F, Soergel DG, Cook E, Burt DA, Singla N. APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the micro-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy. J Pain Res. 2019 Mar 11;12:927-943. doi: 10.2147/JPR.S171013. eCollection 2019.

  PMID: 30881102 RESULT

• Hammer GB, Khanna AK, Michalsky C, Wase L, Demitrack MA, Little R, Fossler MJ, Ayad S. Oliceridine Exhibits Improved Tolerability Compared to Morphine at Equianalgesic Conditions: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials. Pain Ther. 2021 Dec;10(2):1343-1353. doi: 10.1007/s40122-021-00299-0. Epub 2021 Aug 5.

  PMID: 34351590 RESULT

• Beard TL, Michalsky C, Candiotti KA, Rider P, Wase L, Habib AS, Demitrack MA, Fossler MJ, Viscusi ER. Oliceridine is Associated with Reduced Risk of Vomiting and Need for Rescue Antiemetics Compared to Morphine: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials. Pain Ther. 2021 Jun;10(1):401-413. doi: 10.1007/s40122-020-00216-x. Epub 2020 Nov 18.

  PMID: 33210266 RESULT

• Liu Y, Xiao S, Yang H, Lv X, Hou A, Ma Y, Jiang Y, Duan C, Mi W; CAPOPS Group. Postoperative pain-related outcomes and perioperative pain management in China: a population-based study. Lancet Reg Health West Pac. 2023 Jun 10;39:100822. doi: 10.1016/j.lanwpc.2023.100822. eCollection 2023 Oct.

  PMID: 37927993 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Injections; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Dong-Xin Wang, PHD

  Peking University First Hospital

  STUDY DIRECTOR

Central Study Contacts

Xue Li, M.D.

CONTACT

+8618810527114; 3999165@163.com

Dong-Xin Wang, M.D.

CONTACT

+86 010-83572784; wangdongxin@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Department of Anesthesiology

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)