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Comparison of the Efficacy and Safety of Hydromorphone versus Morphine in Thoracic Epidural for Perioperative Analgesia: A Prospective, Randomized Controlled,Double-Blind,Non-Inferiority Trial

Comparison of the Efficacy and Safety of Hydromorphone versus Morphine in Thoracic Epidural for Perioperative Analgesia: A Prospective, Randomized Controlled,Double-Blind,Non-Inferiority Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116565
Enrollment
Unknown
Registered
2026-01-12
Start date
2026-01-14
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Perioperative analgesia

Interventions

Morphine group:Epidural morphine:After induction, 3 mg of morphine is diluted with 0.9% saline to 10 ml for epidural administration
postoperative epidural analgesia is administered as follows: Morphine group (Group M): 0.12% ropivacaine + morphine (20 µg/mL) + saline to a total volume of 250 mL
Hydromorphone group:Epidural hydromorphone:After induction, 0.6 mg of hydromorphone was diluted with 0.9% saline to 10 ml for epidural use. Postoperative epidural analgesia was administered as follows

Sponsors

Zhongshan Hospital,Fudan University(Xiamen Branch)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients undergoing elective thoracic or upper abdominal surgery; 2.Planned postoperative thoracic epidural analgesia; 3.American Society of Anesthesiologists (ASA) physical status I-III; 4.Age: 18-80 years, gender not specified; 5.Patients provide informed consent and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Abnormal liver and kidney function: total bilirubin>3 times the upper limit or alanine aminotransferase and aspartate aminotransferase>5 times the upper limit, elevated blood creatinine = 3 times the baseline value; 2.Contraindications for epidural puncture (such as coagulation dysfunction, puncture site infection, severe spinal deformities); 3.Long term use of opioid drugs or chronic pain syndrome; 4.Preoperative cognitive impairment; 5.Mental and psychological disorders; 6.Alcohol and drug abuse; 7.The drug allergies involved in this experiment; 8.The patient refused to participate in the study.

Design outcomes

Primary

MeasureTime frame
QoR-15 score;

Secondary

MeasureTime frame
Adverse reaction incidence rate;NRS score;Usage of analgesia pump;Epidural removal time and reason for removal;Intraoperative drug usage;Rehabilitation quality-related indicators (postoperative hospitalization duration, time to first bowel movement and gas exhaust, and time to first ambulation);Patient satisfaction with analgesia;Time to first PCEA;

Countries

China

Contacts

Public ContactLiang Chao

Zhongshan Hospital,Fudan University(Xiamen Branch)

Superwm226@126.com+86 159 2167 9955

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026