Local Anaesthetic Infusion For Laparoscopic Hysterectomy

Local Anaesthetic Infusion For Laparoscopic Hysterectomy: A Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Levobupivicaine; Drug: 0.9% Saline

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Chertsey, Surrey, United Kingdom, KT16 0PZ
      • Ashford and St Peter's Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Levobupivicaine	Drug: Levobupivicaine; levobupivicaine 0.5% continous infusion for 48 hours
Placebo Comparator: 0.9% Saline	Drug: 0.9% Saline; 0.9% saline continous infusion for 48 hours

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ashford and St. Peter's Hospitals NHS Trust
• Investigators: Principal Investigator: Jeremy T Wright, MD FRCOG, Ashford and St Peter's Hospitals NHS Foundation Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 7, 2011
• First Posted (Estimate): February 8, 2011

Study Record Updates

• Last Update Posted (Estimate): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 12, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: pain; anaesthetic
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2010JTW01