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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001201965

Enrollment

Registered

2011-11-22

Start date

2009-12-12

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Outcome results