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Reducing tumescent anesthetic injection pain by topical anesthesia pretreatment among patients undergoing endovenous radiofrequency ablation of varicose veins: a double-blind randomized controlled trial

Reducing tumescent anesthetic injection pain by topical anesthesia pretreatment among patients undergoing endovenous radiofrequency ablation of varicose veins: a double-blind randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041767
Enrollment
Unknown
Registered
2021-01-05
Start date
2018-01-01
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

varicose veins

Interventions

A:ELMA

Sponsors

Enze Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
36 Years to 82 Years

Inclusion criteria

Inclusion criteria: 1. Patients with symptomatic primary varicose veins due to GSV incompetence attending vascular outpatient clinic of Enze hospital were invited participating in the study in the period from January 1, 2018 to October 1, 2019. 2. The Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classification and the Venous Clinical Severity Score (VCSS) were recorded before procedure. 3. Patients meeting the criteria of grades C2-C4 (CEAP) suitable to undergo ERA were eligible to include in the study.

Exclusion criteria

Exclusion criteria: 1.Patients with a history of hypersensitivity reactions to anesthesia agents 2.Patients taking medications which suppress the CNS such as diazepam, chlordiazepoxide HCl, alprazolam, etc. 3.Patients with recurrence of varicose veins, alternative axis, venous tortuosity or duplicate veins were not deemed technically feasible. 4.For patients unable to consent or participate in the study or follow up, 5.Extremely nervous (require general anesthesia), 6.Patients unwilling, 7.Previous ipsilateral deep venous thrombosis (DVT), thrombophlebitis (within the last 1 month), arteriosclerosis disease with impalpable foot pluses and ankle brachial pressure index less than 0.8. 8.Patients with pregnancy or postpartum within 6 months.

Design outcomes

Primary

MeasureTime frame
visual analogue scale;

Secondary

MeasureTime frame
venous clinical severity score;Completion of procedure;complication;The satisfaction of patients;

Countries

China

Contacts

Public ContactLu Yongming

Enze Hospital

luym@enzemed.com+86 13819639608

Outcome results

None listed

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