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Effect of sustained-release analgesic system based on artificial dura mater infiltrated hydromorphone on early postoperative rehabilitation of lumbar spine surgery

Effect of sustained-release analgesic system based on artificial dura mater infiltrated hydromorphone on early postoperative rehabilitation of lumbar spine surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105722
Enrollment
Unknown
Registered
2025-07-09
Start date
2025-07-13
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Lumbar disc herniation, spinal canal stenosis

Interventions

Group A:Inject 0.3mg of hydromorphone hydrochloride evenly onto the dura mater patch (3cm x 4cm) using a syringe
Group B:Inject 0.45mg of hydromorphone hydrochloride evenly onto the dura mater patch (3cm x 4cm) using a syringe
Group C:Inject 0.6mg of hydromorphone hydrochloride evenly onto the dura mater patch (3cm x 4cm) using a syringe

Sponsors

Ganzhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Age 18-74 years old; 3. ASA grade I~III; 4. 1-2 segment lumbar fusion patients; 5. No history of alcoholism, no visual or hearing impairment, and able to communicate normally; 6. No mental related diseases and use of psychotropic drugs; 7. Liver and kidney functions were normal.

Exclusion criteria

Exclusion criteria: 1. Patients with poor compliance, unable to complete the study or transfer halfway; 2. Patients who are judged by the investigator as unsuitable to participate in the trial; 3. Previous spinal surgery and spinal tumor surgery; 4. History of allergy to non steroidal drugs and opioids; 5. The patients were complicated with severe organ dysfunction, blood diseases or immune system diseases; 6. Long term history of taking analgesic drugs.

Design outcomes

Primary

MeasureTime frame
VAS scores;

Secondary

MeasureTime frame
Mean arterial pressure, MAP;heart rate;Postoperative recovery time;Patient ambulation time;Total length of postoperative hospitalization;First exhaust time;Patient satisfaction;Intraoperative related indicators (operation time, anesthesia time, blood loss, infusion volume, urine volume);QoR-15;Adverse reactions of patients (such as PONV, drowsiness, POCD, itching, dizziness, etc.);Total number of PCA;The amount of flurbiprofen ester used for remedial analgesia;Pittsburgh sleep quality index (PSQI);Age, gender, height, weight spo2 Preoperative heart rate, preoperative blood pressure, platelet, hemoglobin, white blood cell count, CRP;Post operative Ramsay score;IL-6;TNF-a;Cortisol; S100ß;

Countries

China

Contacts

Public ContactWeibo Zhong

Ganzhou People's Hospital

zhongweibo@mail.gzsrmyy.com+86 187 7905 6260

Outcome results

None listed

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