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Effect of preoperative sleep disturbance on chronic pain after open transforaminal lumbar fusion and instrumentation: a prospective, observational, cohort study

Effect of preoperative sleep disturbance on chronic pain after open transforaminal lumbar fusion and instrumentation: a prospective, observational, cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094519
Enrollment
Unknown
Registered
2024-12-24
Start date
2024-12-25
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

chronic postsurgical pain

Interventions

Sponsors

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Due to degenerative lumbar spondylolisthesis, degenerative lumbar spinal stenosis, lumbar disc herniation and other degenerative diseases of the lumbar spine, general anesthesia or two-level open transforaminal decompression of lumbar fusion and internal fixation were performed for the first time in Nanjing Gulou Hospital; (2) Age 45-65 years old, gender is not limited; (3) ASA grade I-III; (4) Subjects agree to participate in this study and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Emergency surgery; (2) Acute fracture or infection; (3) Spinal tumors, spinal tuberculosis, lumbar scoliosis > 15°; (4) spinal surgery history; (5) the presence of central and peripheral nervous system, neuromuscular system diseases (polio, peripheral neuropathy, etc.) and equipped with a pacemaker; (6) serious organ dysfunction of heart, brain, liver, kidney, etc.; (7) persons addicted to alcohol or drugs; (8) preoperative history of chronic pain and long-term use of analgesic and/or sedative drugs; (9) Preoperative resting pain score (NRS score) > 3; Body mass index (BMI) > 35; (11) Communication or cognitive dysfunction.

Design outcomes

Primary

MeasureTime frame
Chronic pain incidence and pain score 90 days after operation;

Secondary

MeasureTime frame
Incidence and severity of acute postoperative pain;Anxiety, depression and sleep at 90 days after surgery;Types and dosage of analgesics used during and after operation;Postoperative complications during hospitalization;Time of first landing after surgery;Preoperative sleep score;Score of preoperative anxiety and depression;Anxiety and depression score at 24h and 48h after operation;Pain situation, nature of pain, type and dose of remedial analgesics used 90 days after operation;Pain situation, nature of pain, type and dose of remedial analgesics used 30 days after operation;Blood gas indexes during and after operation; Postoperative hospital stay;

Countries

China

Contacts

Public ContactMa Zhengliang

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

mazhengliang1964@nju.edu.cn+86 136 1158 6781

Outcome results

None listed

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