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Phase 1/2 clinical trial of a sustained- release lidocaine sheet for postoperative pain

Phase 1/2 clinical trial of a sustained- release lidocaine sheet for postoperative pain - Phase 1/2 clinical trial of a sustained- release lidocaine sheet for postoperative pain

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011945
Enrollment
100
Registered
2014-01-01
Start date
2014-03-27
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

the mandibular horizontal impacted wisdom tooth

Interventions

Non-administration Pracebo-Control Poly (Lactic-co-Glycolic Acid) 100mg a sustained- release lidocaine sheet (SRLS) 100mg the SRLS 200mg (100mg*2) the SRLS 400mg (100mg*4)

Sponsors

Department Of Anesthesiology Gunma University graduate School of Medicine
Lead Sponsor
Department of Anesthesiology and Intensive Care, Padjadjaran University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Elective operation 2)ASA-PS 1, 2 3)Extraction of the mandibular horizontal impacted wisdom tooth 4)Obtaining an agreement of document about this study

Exclusion criteria

Exclusion criteria: 1)A person taking a drug (e.g. antipsychotic, NSAIDs, and opioid) considered to participate in pain relief or judged that the influence is left even if canceled 2)A patient whose surgical site infects remarkably 3)A patient who has an allergy to Lidocaine, an amide type local anaesthetic agent, Celecoxib, a sulfonamide, Acetaminophen 4)A patient with a serious disturbance of conduction system (e.g. complete atrioventricular block) 5)A patient with peptic ulcer or asthma 6)A patient who has disturbance of consciousness or not able to communicate enough to evaluate correctly 7)A patient who is judged unsuitable for this trial by attending doctor

Design outcomes

Primary

MeasureTime frame
VAS, pain-killer rescue postoperatively and patient satisfaction are compared with those of controled group.

Secondary

MeasureTime frame
VAS, pain-killer rescue postoperatively and patient satisfaction are compared with those of non-administration group.

Countries

Japan,Asia(except Japan)

Contacts

Public ContactToshiyuki SUZUKI

Gunma University Hospital Department Of Anesthesiology

toshis_free-hospital@yahoo.co.jp027-220-8454

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026