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
Medortus Inc
12 participants
Dec 12, 2009
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
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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. This intervention was applied at the end of the surgical intervention taking about 5 minutes.
Locations(1)
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ACTRN12611001201965