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Study on the effectiveness and safety of hydrocodone hydrochloride injection for postoperative analgesia in patients undergoing minimally invasive heart valve replacement surgery

Study on the effectiveness and safety of hydrocodone hydrochloride injection for postoperative analgesia in patients undergoing minimally invasive heart valve replacement surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094930
Enrollment
Unknown
Registered
2024-12-30
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative acute pain in patients undergoing minimally invasive heart valve replacement surgery

Interventions

Sulfentanil group:Intravenous infusion of sufentanil for PCA after surgery
Oxycodone group:intravenous injection of oxycodone for PCA after surgery

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Patients scheduled to undergo minimally invasive heart valve replacement surgery at the hospital. 2.Patients aged 18 to 85. 3.Patients rated as grade III-IV by the American Society of Anesthesiologists. 4.18 kg/m^2<BMI<30 kg/m^2. 5.Patients demonstrate understanding and willingness to utilize patient-controlled intravenous analgesia (PCA). 6.Patients who voluntarily join and sign informed consent after being fully informed of the relevant content of the clinical trial.

Exclusion criteria

Exclusion criteria: 1.Patients with chronic pain syndrome. 2.Patients with a history of opioid allergies, or prolonged opioid use; 3.Patients with severe hepatic and renal dysfunction (including Child–Turcotte–Pugh score >9 and those requiring preoperative dialysis). 4.Patients with cognitive impairment affecting PCA use. 5.Patients with a history of severe postoperative nausea and vomiting, drug abuse or psychiatric disorders. 6.Patients who withdraw from the study during follow-up will also be excluded. 7.Patients undergoing unplanned reoperation after minimally invasive heart valve replacement will be excluded from the study (Exit criteria). 8.Patients with endotracheal intubation for more than 24 hours postoperatively will be withdrawn from the study (Exit criteria).

Design outcomes

Primary

MeasureTime frame
The NRS pain score during coughing at 24 hours postoperatively;

Secondary

MeasureTime frame
the area under the curve (AUC) of Numerical Rating Scale (NRS) scores at rest and during activity between 24 and 48 hours postoperatively(The key secondary outcome);The maximum pain intensity of severe pain within 48 hours after surgery;Anesthesia duration;Postoperative extubation time;Total length of hospital stay;The maximum pain intensity of severe pain within 48 hours after surgery;Time to first postoperative flatus and bowel movement; Time to removal of urinary catheter and drainage tube after surgery;The incidence of respiratory depression, hypoxemia, hypotension, and allergic reactions within 48 hours postoperatively;Quality of Recovery-15 (QoR-15) scores at 24 and 48 hours postoperatively;Time to extubation;Total consumption of the study drug and rescue analgesics within 48 hours after surgery;The total number of patient-controlled analgesia (PCA) button presses and the number of effective presses;NRS scores at 36 and 48 hours postoperatively, assessed at rest and during activity;The incidence of PONV and the dosage of antiemetic drugs;Total length of hospital stay;The incidence of moderate-to-severe pain and the maximum pain intensity within 48 hours postoperatively;The dosage of vasoactive drugs administered within 48 hours after surgery;

Countries

China

Contacts

Public ContactYaomin Zhu

The First Affiliated Hospital of Xi'an Jiaotong University

zhuyaomin_mzk@163.com+86 18629382846

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 20, 2026