Local Anaesthetic Infusion For Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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More hysterectomies are performed laparoscopically either as a total laparoscopic hysterectomy or as a laparoscopically assisted vaginal hysterectomy. The advantages of laparoscopic surgery include quicker hospital discharge, a shorter convalescence and cost effectiveness when compared to open procedures. Laparoscopic hysterectomies (both total and vaginally assisted) can lead to discomfort which may lead to a delay in discharge from hospital. Continuous infusions of local anaesthetic agents given post operatively to the site of operation have the been subject of trials for several operative procedures. To date however there have not been any properly controlled studies evaluating whether there are benefits of giving a local anaesthetic infusion for 48 hours into the pelvis following a total or vaginally assisted laparoscopic hysterectomy. The investigators therefore propose to investigate whether giving a local anaesthetic infusion in this fashion decreases the amount of rescue and patient controlled analgesia needed, and length of hospital stay. In order to do this the investigators wish to conduct a randomised placebo controlled double blind trial.

Official Title
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Local Anaesthetic Infusion For Laparoscopic Hysterectomy: A Randomised Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Levobupivicaine
* Drug: 0.9% Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women undergoing a total laparoscopic or laparoscopically assisted vaginal hysterectomy Exclusion Criteria: Women undergoing surgery for cancer, or are known to be allergic to local anaesthetic agents.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levobupivicaine<br> | Drug: Levobupivicaine<br>* levobupivicaine 0.5% continous infusion for 48 hours<br>|
| Placebo Comparator: 0.9% Saline<br> | Drug: 0.9% Saline<br>* 0.9% saline continous infusion for 48 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Need for 'rescue' analgesia |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Pain intensity |  | 48 hours | 
| Side effects from rescue analgesia |  | 48 hours | 
| Amount of patient controlled analgesia needed |  | 48 hours | 
| Hospital length of stay |  | 48 hours | 
| Patient satisfaction with pain relief |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, anaesthetic