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Local Anaesthetic Infusion For Laparoscopic Hysterectomy

NCT ID: NCT01291147

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-02-28

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.

Detailed Description

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Conditions

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Postoperative Pain

Keywords

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pain anaesthetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Levobupivicaine

Group Type ACTIVE_COMPARATOR

Levobupivicaine

Intervention Type DRUG

levobupivicaine 0.5% continous infusion for 48 hours

0.9% Saline

Group Type PLACEBO_COMPARATOR

0.9% Saline

Intervention Type DRUG

0.9% saline continous infusion for 48 hours

Interventions

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Levobupivicaine

levobupivicaine 0.5% continous infusion for 48 hours

Intervention Type DRUG

0.9% Saline

0.9% saline continous infusion for 48 hours

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ashford and St. Peter's Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremy T Wright, MD FRCOG

Role: PRINCIPAL_INVESTIGATOR

Ashford and St Peter's Hospitals NHS Foundation Trust

Locations

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Ashford and St Peter's Hospitals NHS Foundation Trust

Chertsey, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 24548730 (View on PubMed)

Other Identifiers

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2010JTW01

Identifier Type: -

Identifier Source: org_study_id