Sodium bicarbonate buffering and needle gauge in percutaneous needle aponeurotomy: A blinded controlled trial evaluating injection pain reduction

A single-centre, single-blind controlled trial evaluating the effect of sodium bicarbonate-buffered versus plain lignocaine and needle gauge on injection pain during percutaneous needle aponeurotomy for Dupuytren’s disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87104670

Enrollment

200

Registered

2025-12-07

Start date

2025-10-21

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

Dupuytren’s disease requiring percutaneous needle aponeurotomy in adult patients. Musculoskeletal Diseases

Interventions

Participants will be randomly allocated to receive either 1% plain lignocaine or 1% lignocaine buffered with 8.4% sodium bicarbonate (10:1 ratio) for local anaesthetic infiltration during percutaneous

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older 2. Clinical diagnosis of Dupuytren’s disease requiring percutaneous needle aponeurotomy 3. Disease affecting a single hand 4. Able to provide informed consent 5. Able to understand study procedures and complete pain scoring assessments

Exclusion criteria

Exclusion criteria: 1. Known allergy or hypersensitivity to lignocaine or sodium bicarbonate 2. Previous sensory deficit or paraesthesia in the affected hand 3. Local infection at or near the planned injection site 4. Cognitive impairment that may affect the ability to provide informed consent or reliably report pain scores 5. Inability to understand study procedures or complete Visual Analogue Scale (VAS) assessments

Design outcomes

Primary

Measure	Time frame
Patient-reported pain during local anaesthetic infiltration measured using a 0–10 Visual Analogue Scale (VAS) at the time of injection	—

Secondary

Measure	Time frame
1. Pain at needle puncture measured using a 0–10 Visual Analogue Scale (VAS) at the moment of needle insertion 2. Incidence of immediate adverse events (e.g., allergic reaction, vasovagal response) recorded during and up to 30 minutes after the procedure 3. Difference in pain scores during needle insertion between 25G and 27G needles measured using a 0–10 Visual Analogue Scale (VAS) at the time of injection 4. Association between patient demographic factors (age and sex) and pain scores during local anaesthetic infiltration measured using a 0–10 Visual Analogue Scale (VAS) at the time of injection	—

Measure

Time frame

1. Pain at needle puncture measured using a 0–10 Visual Analogue Scale (VAS) at the moment of needle insertion 2. Incidence of immediate adverse events (e.g., allergic reaction, vasovagal response) recorded during and up to 30 minutes after the procedure 3. Difference in pain scores during needle insertion between 25G and 27G needles measured using a 0–10 Visual Analogue Scale (VAS) at the time of injection 4. Association between patient demographic factors (age and sex) and pain scores during local anaesthetic infiltration measured using a 0–10 Visual Analogue Scale (VAS) at the time of injection

—

Countries

Australia

Contacts

Public ContactIshith Seth

iseth@phcn.vic.gov.au+61 397847777

Outcome results

None listed

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