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Effectiveness of topical anesthesia as an adjuvant to local anesthetic injection during open surgical release of trigger digit: a randomized controlled trial

Effectiveness of topical anesthesia as an adjuvant to local anesthetic injection during open surgical release of trigger digit: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190106001
Enrollment
100
Registered
2019-01-06
Start date
2019-05-01
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

Trigger digit Trigger digit&#44

Interventions

The patients in EMLA group will receive 3 grams of EMLA drug which contain in the unlabeled container and apply to the intact skin at intended surgical area by research assistant. Then&#44
EMLA is sealed with waterproof occlusive dressing (TegadermTM Film&#44
3M Healthcare&#44
Germany) to contain the drug to the skin for 90 minutes.,The patients in placebo group will receive 3 grams of placebo which is cream base without anesthetic property. The placebo has same appearance&
odor&#44
color and consistency with EMLA and contain in the similar appearance of unlabeled container. Placebo is applied to the intact skin at intended surgical area by research assistant. Then&#44
placebo is sealed with waterproof occlusive dressing (TegadermTM Film&#44
Germany) to contain the placebo to the skin for 90 minutes.
Experimental Procedure/Surgery,Placebo Comparator Procedure/Surgery
EMLA group,Placebo group

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Trigger digit patients Quinnell grade II-IV or Quinnell grade I with failure of conservative treatment for 3 months - Scheduled for open release surgery at Siriraj Hospital - Age > 18 years

Exclusion criteria

Exclusion criteria: - Known history of sensitivity to local anesthetics of amide type (lidocaine, mepivacaine, prilocaine, bupivacaine, ropivacaine) or cream base - Contraindication to EMLA: • Patients treated with class III anti-arrhythmic drugs (amiodarone, bretylium, sotalol, dofetilide) • Patients with congenital or idiopathic methemoglobinemia - Concomitant ipsilateral carpal tunnel syndrome or de Quervain’s disease - Recurrent disease at the same digit - Multiple digits operate at the same time (> 2 digits) - Communication problems - History of depression or anxiety disorders

Design outcomes

Primary

MeasureTime frame
VAS for overall pain throughout the operation day of operation Visual analog scale

Secondary

MeasureTime frame
VAS for pain during needle insertion day of operation Visual analog scale,VAS for pain during local anesthetic infiltration day of operation Visual analog scale,Thai short-form McGill pain questionnaire day of operation 15 items questionnaire about pain in 4-likert scale for each item,Patient's overall satisfaction day of operation 5-likert scale,Complications day of operation, 2 weeks follow-up Presence of complications

Countries

Thailand

Contacts

Public ContactPanai Laohaprasitiporn

Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University

panai.lao@mahidol.ac.th66865678565

Outcome results

None listed

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