Pre-emptive Local Anaesthesia in Gynecological Laparoscopy
Recruitment status was Not yet recruiting
Pre-emptive local anaesthetics are widely used in laparoscopic surgery, but there is no really consistent evidence that it is useful. Studies in the literature have shown contradicting results. At our hospital we are currently using pre-emptive local anaesthetics in the trocar areas, but as the literature does not give a clear and clinically relevant answer, we need to find out more. This study aims to see if pre-emptive local anaesthetics are useful in the setting of our day-case, laparoscopic surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||Pre-emptive Local Anaesthesia in Gynecological Laparoscopy|
- Postoperative movement-evoked pain [ Time Frame: 5 hours postoperative ] [ Designated as safety issue: No ]The primary outcome of the study will be movement-evoked pain (MEP) 5 hours after surgery, as half-life of bupivacaine is 4-6 hours. Movement-evoked pain is the most important outcome measure, because the goal is to get the patient back to normal, daily activities as soon as possible.
- Pain at rest [ Time Frame: 2 and 5 hours postoperative ] [ Designated as safety issue: No ]Secondary outcome measures will be pain at rest at 2 and 5 hours postoperative.
- Rescue analgetics [ Time Frame: 5 hours postoperative ] [ Designated as safety issue: No ]Use of rescue analgesics postoperative.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: bupivacaine
Injection of 5 ml bupivacaine, 5mg/ml in each port site.
Drug: Bupivacaine 5mg/ml
50 mg injection as local anestesia
Other Name: Marcain
Placebo Comparator: Saline
Injection of 5 ml saline in each port site.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01677143
|Contact: Ravndal Caroline, MDfirstname.lastname@example.org|
|Stavanger University Hospital||Not yet recruiting|
|Stavanger, Norway, 4068|
|Contact: Caroline Ravndal, MD email@example.com|
|Principal Investigator: Caroline Ravndal, MD|
|Principal Investigator:||Caroline Ravndal, MD||Helse Stavanger HF|