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Effect and safety of topical gel containing a combination of Lidocaine and Prilocaine in the management of hemodialysis needling pain in patients on long term dialysis

Efficacy & safety of topical Lidocaine and Prilocaine gel for arteriovenous fistula cannulation pain in hemodialysis patients A Crossover Randomized Control Trial - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073516
Enrollment
50
Registered
2024-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: N186- End stage renal disease

Interventions

Intervention1: Lidocaine 2.5% and Prilocaine 2.5% gel: A thick layer of gel will be applied to the skin, under occlusive dressing on the arteriovenous fistula hand where the needles will be inserted,

Sponsors

Manipal College of Health Professions
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients on hemodialysis through an arteriovenous fistula. Greater than three months of maintenance hemodialysis. Those who rate their pain as mild, moderate or severe on AVF cannulation pain (as measured by VAS) during screening.

Exclusion criteria

Exclusion criteria: Hemodialysis patients with AVG as their permanent vascular access and patients with temporary access like catheters. Hemodynamically unstable patients. Skin infections or skin lesions or open wounds or ulcers. Diminished mental capacity or not able to communicate. Any known history of allergic reactions to lignocaine or prilocaine or any other topical anesthetics or other drugs.

Design outcomes

Primary

MeasureTime frame
Change in AVF cannulation pain (as measured by the Visual Analogue Scale) score from baseline.Timepoint: Day 1, Day 3

Secondary

MeasureTime frame
Safety of topical Lidocaine and Prilocaine gel in AVF cannulation painTimepoint: Day 1, Day 3

Countries

India

Contacts

Public ContactDr Indu R Rao

Kasturba Medical College, MAHE, Manipal

indu.rao@manipal.edu9592896393

Outcome results

None listed

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