women having a total laparoscopic or vaginally assisted laparoscopic hysterectomy
Conditions
Interventions
Trade Name: Chirocaine
Product Name: Chirocaine
Product Code: PL 00037/0301
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration
Sponsors
Ashford and St Peters Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: women undergoing total laparoscopic or laparoscopic assissted vaginal hysterectomy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Women with a history of hypersensitivity to local anaesthetics. Women undergoing hysterectomy for cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Need for 'rescue' analgesia in women who have an infusion of chirocaine compared to normal saline.;Secondary Objective: • Pain intensity (on movement and rest) • Side effects from rescue analgesia • Amount of patient controlled analgesia needed • Hospital length of stay • Patient satisfaction with pain relief in women who have an infusion of chirocaine compared to normal saline.;Primary end point(s): Need for 'rescue' analgesia in women who have an infusion of chircocaine 0.5% compares to normal saline 0.9% | — |
Countries
United Kingdom
Outcome results
None listed