A study to define the pharmacokinetic properties of lignocaine gel applied topically on a surgical field

Phase 1

Completed

• Conditions: The effects of lignocaine on surgical wounds in laparoscopy or hysteroscopy; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12611001201965
• Lead Sponsor: Medortus Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

female aged 18 to 80
Scheduled to undergo gynaecological surgery, involving either laparoscopy or hysteroscopy
Anaesthesia risk category level I and II

Exclusion Criteria

Renal or hepatic impairment on history, general clinical examination or in medical record
Medical or other condition(s) (including heart failure) placing candidate in anaesthesia risk category level III or higher
Known allergy to lignocaine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if lignocaine, applied as a gel onto a surgical field, does absorb into the blood stream and, if so, to what extent by blood samples collected at time of induction of anaesthesia (time 0) and at the following times (+ 10%) after application of Pluscaine?: 0.25h, 0.5h, 0.75h, 1.0h, 1.5h, 2.0h, 3.0h, 4.0h, 6.0h, and 24.0h.[The Pluscaine(study medication) will be applied at the end of the surgical intervention]

Secondary Outcome Measures

Name	Time	Method
To define the Cmax (maximum concentration in serum), Tmax (time at which the maximum concentration occurs) and area under the concentration curve (AUC) of 6mLs of Pluscaine[Blood samples will be collected at time of induction of anaesthesia (time 0) and at the following times (+ 10%) after application of Pluscaine: 0.25h, 0.5h, 0.75h, 1.0h, 1.5h, 2.0h, 3.0h, 4.0h, 6.0h, and 24.0h.]