CompletedPhase 1ACTRN12611001201965

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

A study to define the pharmacokinetic properties of lignocaine gel applied topically on a surgical field for females sheduled to undergo gynaecological surgery involving either laparoscopy or hysteroscopy


Sponsor

Medortus Inc

Enrollment

12 participants

Start Date

Dec 12, 2009

Study Type

Interventional

Conditions

Summary

The aim of this study is to determine if an anaesthetic product applied as a gel onto a surgical field does absorb into the blood stream and, if so, to what extent. It is important to have this information because anaesthetic products can become toxic at a certain concentration. Twelve women who will undergo surgery at the Royal Hospital for Women (RHW) will be recruited for this study. Six among them will have laparoscopic surgery involving the abdominal wall and the pelvic organs; the other six will have surgery involving the uterus. Women will be approached at the public clinics of the RHW. Women will be given written and verbal information regarding the study at least a week prior to undergoing the surgery. The consented subjects will have the anaesthetic gel applied to the surgical wounds at the end of their procedure. Blood samples will be taken once before and ten times after the application of gel. The timing of the sampling will be spread over a period of 24 hours. All samples will be kept in a freezer until the end of the study and sent to a specialised laboratory for measurement of the concentration of anaesthetic product in the blood. The subjects will be monitored with regard to blood pressure, pulse and other vital signs as per normal hospital protocol and discharged from the study 24hours after their surgery.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study measures how lignocaine (a local anaesthetic) gel is absorbed into the bloodstream when applied directly to the surgical site during gynaecological surgery. Women aged 18 to 80 undergoing laparoscopy or hysteroscopy with low anaesthesia risk (category I or II) are eligible. Those with liver or kidney problems or allergy to lignocaine are excluded.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

To determine if reconstituted lignocaine at 4.8% with buffer , applied as a 6 ml gel (named Pluscaine) onto a surgical field once only, does absorb into the blood stream and, if so, to what extent. T

To determine if reconstituted lignocaine at 4.8% with buffer , applied as a 6 ml gel (named Pluscaine) onto a surgical field once only, does absorb into the blood stream and, if so, to what extent. This intervention was applied at the end of the surgical intervention taking about 5 minutes.


Locations(1)

Australia

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ACTRN12611001201965