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Effect and Safety of Dexmedetomidine or Dexamethasone as Adjuvant for Ropivacaine in Local Wound Infiltration for Posterior Cervical Single Open-door Laminoplasty: a Prospective, Randomized, Double-blind, Controlled Clinical Trial

Effect and Safety of Dexmedetomidine or Dexamethasone as Adjuvant for Ropivacaine in Local Wound Infiltration for Posterior Cervical Single Open-door Laminoplasty: a Prospective, Randomized, Double-blind, Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048828
Enrollment
Unknown
Registered
2021-07-18
Start date
2021-08-08
Completion date
Unknown
Last updated
2022-03-28

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

Conditions

Incision pain after posterior cervical single open-door laminoplasty

Interventions

Ropivacaine group:local wound infiltration with ropivacaine and normal saline
Ropivacaine + dexamethasone group:local wound infiltration with ropivacaine and dexamethasone
Ropivacaine + dexmedetomidine group:local wound infiltration with ropivacaine and dexmedetomidine

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. After fully informed of the benefits and risks of the trial, patient agreed to participate in the trial and voluntarily signed the informed consent; 2. Aged from 20 to 70 years; 3. Patients had the clinical manifestations of upper and / or lower extremity nerve compression,and confirmed by MRI and or CT as cervical spondylotic myelopathy, congenital cervical spinal canal stenosis or ossification of the posterior longitudinal ligament , and required for posterior cervical single open-door laminoplasty; 4. Conservative treatment included physical therapy, pain medication and local block therapy were ineffective for at least 3 months; 5. The grade of American Society of anesthesiologists is classified as I-II; 6. Patient controlled analgesia device (PCA) can be used independently.

Exclusion criteria

Exclusion criteria: 1. Previous history of cervical instrumentation implantation; 2. Known allergy to test drugs (dexamethasone, dexmedetomidine, ropivacaine, parecoxib, ibuprofen); 3. Nerve compression symptoms caused by cervical or other tumors; 4. Ischemic heart disease, bradycardia (heart rate 35), Weight <=50 kg, liver and kidney dysfunction); 6. Long-term use of hormones or sedative analgesics; 7. Systemic or local active or chronic infection, such as AIDS, syphilis, hepatitis; 8. Severe mental illness (psychosis, severe affective disorder or schizophrenia); 9. Recent or previous history of alcohol, opioid or narcotic drug dependence; 10. Autoimmune diseases affecting musculoskeletal system (such as systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis); 11. Pregnant or ready to be pregnant; 12. For mental or physical reasons, they can't master the PCA device, or they can't answer the pain questionnaire.

Design outcomes

Primary

MeasureTime frame
The time of first use of analgesics;

Secondary

MeasureTime frame
Total usage of hydromorphone in PCA;NRS pain scores of incision at rest;NRS pain scores of incision during neck movement;

Countries

China

Contacts

Public ContactFang Zhong

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

568864410@qq.com+86 27 63639607

Outcome results

None listed

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