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Analgesic effectiveness of single ropivacaine epidural injection versus intravenous patient-controlled analgesia after single level lumbar decompression or arthrodesis surgery

Analgesic effectiveness of single ropivacaine epidural injection versus intravenous patient-controlled analgesia after single level lumbar decompression or arthrodesis surgery: A randomized, multi-center, observer blinded, active-controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003779
Enrollment
98
Registered
2019-04-15
Start date
2017-11-21
Completion date
Unknown
Last updated
2021-05-24

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

Conditions

None listed

Interventions

Procedure/Surgery : In the IV-PCA group, a mechanical intravenous PCA (Automed 3300
AceMedical, Seoul, South Korea) was used immediately before the end of the operation. The mode of the PCA was 1 mL per hour, 1 mL per injection, locking time 15 min FTN fentanyl 25 ? x kg, ketorolac 2

Sponsors

Chung-Ang Univerisity Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 20 to 80 years 2. The patients with degenerative lumbar disease (spinal stenosis, degenerative spondylolisthesis) 3. If the applicant (signable only) or a legal representative has signed the agreement after fully understanding the contents of the trial,

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications (blood coagulation disorder, infection) or epidural injection, or experienced partial anesthetic adverse events 2. Patients with clinically significant impairment of cardiovascular, digestive, respiratory, endocrine, or central nervous system, and those who are at risk for administration of the remedy Ketorolac or fentanyl 3. Patients with past history of drug analgesics (except tramadol) within 2 weeks before scheduled surgery 4. Those who have collagen-vascular or autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus) or who have been treated for malignant tumors within 5 years 5. Patients with impaired immunity or clinically significant abnormalities in clinical laboratory tests at screening 6. Pregnant or lactating women 7. Weight less than 45 kg or less than 100 kg 8. Any other person who is considered inappropriate by the medical examiner 9. Those who refused to participate in the study

Design outcomes

Primary

MeasureTime frame
Numeric rating scale (NRS) for low back pain measured from the time of exit from recovery room

Secondary

MeasureTime frame
The number of times the pain-control button was pressed from the time of exit from recovery room;Quantity of ketorolac and rescue fentanyl used up to 48 hours after entering the recovery room;The number of nausea and vomiting that require oral antiemetics;Constipation that lasts more than 3 days after surgery;Urinary retension symptom;Likert satisfaction scale scoring;Numeric rating scale (NRS), oswestry disability index(ODI)

Countries

Korea, Republic of

Contacts

Public ContactKWANG SUP SONG

Chung-Ang Univerisity Hospital

ksong70@hanmail.net+82-2-6299-1589

Outcome results

None listed

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