Skip to content

Effect and Safety of Dexmedetomidine and Dexamethasone as Adjuvant for Ropivacaine in Local Wound Infiltration for Post-Operative Analgesia in Lumbar Spine Fusion: a Prospective, Randomized, Double-blind, Controlled Clinical Trial

Effect and Safety of Dexmedetomidine and Dexamethasone as Adjuvant for Ropivacaine in Local Wound Infiltration for Post-Operative Analgesia in Lumbar Spine Fusion: a Prospective, Randomized, Double-blind, Controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042880
Enrollment
Unknown
Registered
2021-01-30
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

lumbar spinal fusion

Interventions

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

Sponsors

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

Eligibility

Sex/Gender
All
Age
30 Years to 75 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 30-75 years; 3. Clinical manifestations of low back pain and / or lower extremity nerve root pain, and MRI and / or CT confirmed central canal stenosis, lateral recess stenosis or intervertebral foramen stenosis of L1-S1 vertebrae: (1) Lower extremity radiculopathy: pain and / or weakness or paralysis and / or at least one specific sensory abnormality in L1-S1 vertebral nerve root distribution area; (2) Neurogenic intermittent claudication - long time Leg pain and / or weakness and / or abnormal sensation when walking or standing; (3) Lumbar spinal fusion of 1-3 segments is required; 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 lumbar instrumentation implantation; 2.Known allergy to test drugs (dexamethasone, dexmedetomidine, ropivacaine, parecoxib, ibuprofen); 3.Lumbar spinal fusion with more than 3 segments is required; 4.Meyerding grade III or higher lumbar spondylolisthesis; 5.Ischemic heart disease, bradycardia (heart rate 35), liver and kidney dysfunction); 8.Long-term use of hormones or sedative analgesics; 9.Systemic or local active or chronic infection, such as AIDS, syphilis, hepatitis; 10.Severe mental illness (psychosis, severe affective disorder or schizophrenia); 11.Recent or previous history of alcohol, opioid or narcotic drug dependence; 12.0Autoimmune diseases affecting musculoskeletal system (such as systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis); 13.Pregnant or ready to be pregnant; 14.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
The total dosage of fentanyl in PCA within 48 hours after operation;VAS pain score of lumbar at rest at 6 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hoursafter operation;VAS pain score of patients with lumbar active lifting off the bed at 6 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after operation;

Countries

China

Contacts

Public ContactFang Zhong

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

568864410@qq.com027-63639607

Outcome results

None listed

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