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Comparing Pain Scores in Wide-Awake Local Anesthesia without Tourniquet Technique vs. Regional Anesthesia for Distal Radius Fracture Fixation: A Randomized Controlled Trial.

Comparing Pain Scores in Wide-Awake Local Anesthesia without Tourniquet Technique vs. Regional Anesthesia for Distal Radius Fracture Fixation: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240905005
Enrollment
38
Registered
2024-09-05
Start date
2024-07-10
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

distal end radius patient with surgery indication Walant , der , distal end radius with walant

Interventions

2% Lidocaine 50 ml [Dronil-A, M&amp
H Manufacturing, Bangkok] mixed with Adrenaline (1:1000) 1 ml, 0.9% NaCl 50 ml, and 8.4% NaHCO3 10 ml, resulting in a solution of 111 ml. This solution is then used at a dosage of 40 ml. Inject 10 ml
Experimental Procedure/Surgery,Experimental Procedure/Surgery
WALANT,Conventional regional anesthesia

Sponsors

Research facilitation division Vajira hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients with a distal end radius fracture (distal end radius fracture) from an accident who require surgery to replace the distal bone plate using a Volar locking plate, as indicated by the AAOS 2009 guidelines. Age 18 to 85 years, patients who are generally healthy without chronic diseases or have well-controlled chronic diseases (ASA 1-2). Hypertension: SBP less than 180 mmHg and DBP less than 110 mmHg. Diabetes: HbA1C less than 8% or POCT glucose 80-180 mg/dL with no end-organ damage. Obesity: BMI between 30 and 40. Patients with other mild and well-controlled chronic diseases.

Exclusion criteria

Exclusion criteria: Patients with a history of allergy to lidocaine or drugs in the same class, a history of allergy to Acetaminophen (paracetamol), psychiatric patients with severe symptoms despite treatment with medication or other procedures, patients with peripheral artery disease, patients with polytrauma (injuries involving two or more parts of the body), patients with brain injuries requiring surgery, patients for whom the anesthesiologist recommends general anesthesia, patients with distal radius fractures classified as AO 23A1 or 23C3, patients with severe inflammation or skin infections at the wrist, patients with coagulation disorders, patients with liver diseases such as hepatitis or cirrhosis, patients who are unwilling to participate in the study, patients unable to communicate, patients with impaired cognitive function, patients with end-stage renal disease (due to the need for pain medication according to protocol), patients with a history of gastrointestinal bleeding (due to the need for pain medication according to protocol), patients with a history of allergy to NSAIDs and opioids, or pregnant women.

Design outcomes

Primary

MeasureTime frame
Pain score 0,2,6,12,24,48,72 hour post op VNRS

Secondary

MeasureTime frame
Intraoperative pain Pain before incision,First incision, manipulate , first screw drill , closed wound Verbal numerical pain score,Film parameter post op Add follow up 2,4 week and 3,6 month Measure from film,Grip and pinch strenght At follow up Using jamar plus tools,ROM At follow up Patient RoM,Thai PRWE (Patient-Rated Wrist Evaluation) score At follow up Record data from Thai PRWE (Patient-Rated Wrist Evaluation)

Countries

Thailand

Contacts

Public ContactKorrawit Phumphrao

Vajira hospital

Korrawit.phu@nmu.ac.th0849991918

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026