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Effect of bupivacaine combined with morphine intrathecal injection on postoperative quality of recovery in patients undergoing pulmonary surgery: a multicenter, randomized, double-blind, controlled clinical study

Effect of bupivacaine combined with morphine intrathecal injection on postoperative quality of recovery in patients undergoing pulmonary surgery: a multicenter, randomized, double-blind, controlled clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092935
Enrollment
Unknown
Registered
2024-11-26
Start date
2024-12-11
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Lung disease

Interventions

IT group:Intrathecal injection of 0.25mg morphine and 3mg bupivacaine

Sponsors

The Affiliated Hospital of Yangzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients undergoing elective lung surgery; 2.18-65 years old, regardless of sex; 3.ASA I-III; 4.BMI18.5~30kg/m^2; 5.plan to stay in hospital for more than 48 hours after operation; 6.clearly understand and voluntarily participate in the study, and the informed consent form shall be signed by the person or his family member;

Exclusion criteria

Exclusion criteria: 1.patients with severe cardiac, liver and renal dysfunction before operation; 2.long-term use of analgesics, sedatives and alcoholism; 3.Intraspinal puncture is contraindicated; 4.suffered from severe neuropsychiatric diseases such as cerebrovascular disease, Alzheimer's disease, epilepsy and Parkinson's disease; 5.previous history of intracranial surgery or craniocerebral injury; 6.those with severe vision, hearing, language impairment or other reasons unable to communicate; 7.Patients with severe cognitive impairment with a score of 17 or lower on the Chinese version of the Mini-Mental State Examination (MMSE); 8.patients with allergy to morphine, local anesthetics, non-steroidal anti-inflammatory drugs (NSAID) or contraindications;

Design outcomes

Primary

MeasureTime frame
Recovery quality 1 day after surgery;

Secondary

MeasureTime frame
Recovery quality 2 day and 3 day after surgery;Pain intensity at rest and during movement within 72 hours after surgery;The lowest and highest systolic blood pressure and highest heart rate during the operation;The time of the first remedy and the number of remedies;Total amount of opioids;Occurrence of adverse reactions;Postoperative recovery index;Postoperative complications;Chronic pain score;Sleep quality;Postoperative delirium;Homeostatic Model Assessment of Insulin Resistance;

Countries

China

Contacts

Public ContactJangyou Zhang

The Affiliated Hospital of Yangzhou University

zhangjianyou@yzu.edu.cn+86 13835813811

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 28, 2026