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The analgesic effect of artificial dura mater hydromorphone epidural sustained-release analgesia on postoperative lumbar spine patients: a randomized controlled trial

The analgesic effect of artificial dura mater hydromorphone epidural sustained-release analgesia on postoperative lumbar spine patients: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096777
Enrollment
Unknown
Registered
2025-02-06
Start date
2025-02-20
Completion date
Unknown
Last updated
2025-02-10

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 G: Gelatin Sponge Group:2ml (0.4mg) of hydromorphone hydrochloride was evenly dripped onto a gelatin sponge (6cm × 2cm × 0.5cm) using a syringe, allowing the gelatin sponge to fully and uniforml
Group A: Artificial dura mater group:Inject 2ml (0.4mg) of hydromorphone hydrochloride evenly onto the dura mater patch (3cm x 4cm) using a syringe to ensure thorough and uniform infiltration of the p

Sponsors

Ganzhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years

Inclusion criteria

Inclusion criteria: Patients aged 18-74 undergoing elective surgery using artificial dura mater for the prevention or treatment of spinal cord injury; Surgical area 1-2 segments, ASA grade I-III; No history of alcohol abuse, no visual or hearing impairments, and able to communicate normally; No mental illness or use of psychiatric drugs; Normal liver and kidney function.

Exclusion criteria

Exclusion criteria: Previous spinal surgery history and spinal tumor surgery history; History of allergy to nonsteroidal and opioid drugs; Long term history of taking analgesic drugs.

Design outcomes

Primary

MeasureTime frame
VAS scores;

Secondary

MeasureTime frame
Post operative Ramsay score;Mean arterial pressure, MAP;heart rate;IL-6;S100ß;Adverse reactions of patients (such as PONV, drowsiness, POCD, itching, dizziness, etc.);Pittsburgh Sleep Quality Index (PSQI);The amount of flurbiprofen ester used for remedial analgesia;Total number of PCA;Postoperative patient recovery index;patient satisfaction;

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