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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levobupivicaine | Active Comparator |
| |
| 0.9% Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivicaine | Drug | levobupivicaine 0.5% continous infusion for 48 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| • Need for 'rescue' analgesia | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| • Pain intensity | 48 hours | |
| Side effects from rescue analgesia | 48 hours | |
| Amount of patient controlled analgesia needed |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy T Wright, MD FRCOG | Ashford and St Peter's Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ashford and St Peter's Hospitals NHS Foundation Trust | Chertsey | Surrey | KT16 0PZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24548730 | Derived | Andrews V, Wright JT, Zakaria F, Banerjee S, Ballard K. Continuous infusion of local anaesthetic following laparoscopic hysterectomy--a randomised controlled trial. BJOG. 2014 May;121(6):754-60; discussion 761. doi: 10.1111/1471-0528.12610. Epub 2014 Feb 19. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| 0.9% Saline |
| Drug |
0.9% saline continous infusion for 48 hours |
|
| 48 hours |
| Hospital length of stay | 48 hours |
| Patient satisfaction with pain relief | 48 hours |
| D012816 | Signs and Symptoms |