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Local Anaesthetic Infusion For Laparoscopic Hysterectomy

A

Ashford and St. Peter's Hospitals NHS Trust

Status and phase

Completed
Phase 4

Conditions

Postoperative Pain

Treatments

Drug: Levobupivicaine
Drug: 0.9% Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT01291147
2010JTW01

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

Levobupivicaine
Active Comparator group
Treatment:
Drug: Levobupivicaine
0.9% Saline
Placebo Comparator group
Treatment:
Drug: 0.9% Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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