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OpenTrials
Completed

NCT Number: NCT01291147

Local Anaesthetic Infusion For Laparoscopic Hysterectomy

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ashford and St Peter's Hospitals NHS Foundation Trust

Chertsey, Surrey, KT16 0PZ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivicaine

Drug

levobupivicaine 0.5% continous infusion for 48 hours

0.9% saline

Drug

0.9% saline continous infusion for 48 hours

Primary outcomes

  1. • Need for 'rescue' analgesia

    Time frame: 48 hours

Secondary outcomes

  1. • Pain intensity

    Time frame: 48 hours

  2. Side effects from rescue analgesia

    Time frame: 48 hours

  3. Amount of patient controlled analgesia needed

    Time frame: 48 hours

  4. Hospital length of stay

    Time frame: 48 hours

  5. Patient satisfaction with pain relief

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Ashford and St. Peter's Hospitals NHS Trust

Other

Registry information

Official study title

Local Anaesthetic Infusion For Laparoscopic Hysterectomy: A Randomised Controlled Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Feb 8, 2011
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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