Topical Formulations of Liposomal Local Anesthetics

NCT01054547 | Completed Phase 1 DMC

• 1 other identifier: 093/2006
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.

Conditions

Administration, Topical Drug; Administration, Topical; Anesthetic Drugs

Keywords

topical anesthetic; liposomal ropivacaine; dentistry

Outcome Measures

Primary Outcomes (1)

• After topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester.

  10 minutes

Secondary Outcomes (1)

• The efficacy of the topical anesthetics was measured after a simulation of a local anesthesia in the application site (insertion of a 30 gauge needle until periosteum contact).

  10 seconds after removal of topical formulation

Study Arms (2)

Liposomal ropivacaine, topical

PLACEBO COMPARATOR

The topical anesthetics were applied at the region of right and left maxillary lateral incisors at the buccal mucosa.

Drug: Ropivacaine

Liposomal ropivacaine, palatal mucosa

PLACEBO COMPARATOR

Topical formulations were applied at the palatal mucosa at the right canine region and efficacy of topical formulations was accessed through insertion of a 30 gauge needle and injection of anesthetic solution.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.

Also known as: Topical anesthesia in the palatal mucosa

Liposomal ropivacaine, palatal mucosa

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy

You may not qualify if:

• Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Piracicaba Dental School

Piracicaba, São Paulo, 13414903, Brazil

Location

Related Publications (2)

• Franz-Montan M, de Paula E, Groppo FC, Silva AL, Ranali J, Volpato MC. Liposome-encapsulated ropivacaine for intraoral topical anesthesia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Dec;110(6):800-4. doi: 10.1016/j.tripleo.2010.07.005.

  PMID: 21112538 DERIVED

• Franz-Montan M, de Paula E, Groppo FC, Silva AL, Ranali J, Volpato MC. Liposomal delivery system for topical anaesthesia of the palatal mucosa. Br J Oral Maxillofac Surg. 2012 Jan;50(1):60-4. doi: 10.1016/j.bjoms.2010.10.018. Epub 2010 Nov 23.

  PMID: 21106282 DERIVED

MeSH Terms

Interventions

Ropivacaine; Anesthesia

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 22, 2010
• Study Start: September 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: April 1, 2007
• Last Updated: January 22, 2010

Record last verified: 2006-05

Locations

BR (1)