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Comparison of Local Analgesic Efficacy Between Combined Tramadol-Lidocaine and Lidocaine Alone in Core Needle Biopsy for Musculoskeletal Tumors : A Randomized Controlled Trial

Comparison of Local Analgesic Efficacy Between Combined Tramadol-Lidocaine and Lidocaine Alone in Core Needle Biopsy for Musculoskeletal Tumors : A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260405001
Enrollment
28
Registered
2026-04-05
Start date
2025-05-16
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Pain associated with core needle biopsy in patients with suspected bone and soft tissue tumors (musculoskeletal tumors) Core needle biopsy

Interventions

Local anesthesia will be administered using 2% lidocaine with adrenaline (9 mL) combined with tramadol 50 mg (1 mL). A waiting period of 5 minutes will be observed before performing the core needle bi
Experimental Drug,Active Comparator Drug
Tramadol + Lidocaine,Lidocaine alone

Sponsors

Maha Vajiralongkorn Foundation, Phramongkutklao Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria 1. Patients attending the outpatient department of the Orthopedic Division, Phramongkutklao Hospital 2.Patients diagnosed with a bone or soft tissue tumor of the extremities (upper or lower limbs) with an indication for core needle biopsy 3.Patients undergoing core needle biopsy for the first time 4.Age 20 years or older 5.Patients with tumors without pre-existing pain at the biopsy site

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1.Patients with comorbidities that may affect pain perception (e.g., diabetes mellitus, menstrual-related conditions) 2.Patients with systemic inflammatory diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus) 3.Known allergy to paracetamol, tramadol, or lidocaine 4.Patients with needle phobia 5.Patients with contraindications to core needle biopsy 6.Patients with impaired consciousness or inability to fully cooperate 7.Patients who decline participation or refuse to provide informed consent 8.Tumors located in highly sensitive areas with dense nerve distribution (e.g., hand, foot) 9.Patients who are unable to complete follow-up or are lost to follow-up

Design outcomes

Primary

MeasureTime frame
Pain intensity (Numeric Rating Scale, NRS) at 0, 1, 6, 12, 24, and 48 hours after core needle biopsy 0, 1, 6, 12, 24, and 48 hours Numeric Rating Scale

Secondary

MeasureTime frame
Time to first use of oral analgesics after biopsy within 48 hours after end of the intervention hours,Total consumption of oral analgesics after biopsy within 48 hours after end of the intervention tab,Diagnostic concordance rate between biopsy results and final diagnosis (%) within one year after end of the intervention Diagnostic Concordance Rate (%)

Countries

Thailand

Contacts

Public ContactSila Weeramatpakorn

Department of Orthopaedic Surgery, Phramongkutklao Hospital

sunsilsilasky@gmail.com0830377555

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026