Back to resultsLocal Anaesthetic Infusion For Laparoscopic Hysterectomy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Levobupivicaine
0.9% Saline
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring pain, anaesthetic
Eligibility Criteria
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.
Sites / Locations
- Ashford and St Peter's Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Levobupivicaine
0.9% Saline
Arm Description
Outcomes
Primary Outcome Measures
• Need for 'rescue' analgesia
Secondary Outcome Measures
• Pain intensity
Side effects from rescue analgesia
Amount of patient controlled analgesia needed
Hospital length of stay
Patient satisfaction with pain relief
Full Information
NCT ID
NCT01291147
First Posted
February 4, 2011
Last Updated
November 12, 2013
Sponsor
Ashford and St. Peter's Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01291147
Brief Title
Local Anaesthetic Infusion For Laparoscopic Hysterectomy
Official Title
Local Anaesthetic Infusion For Laparoscopic Hysterectomy: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ashford and St. Peter's Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
pain, anaesthetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levobupivicaine
Arm Type
Active Comparator
Arm Title
0.9% Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Levobupivicaine
Intervention Description
levobupivicaine 0.5% continous infusion for 48 hours
Intervention Type
Drug
Intervention Name(s)
0.9% Saline
Intervention Description
0.9% saline continous infusion for 48 hours
Primary Outcome Measure Information:
Title
• Need for 'rescue' analgesia
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
• Pain intensity
Time Frame
48 hours
Title
Side effects from rescue analgesia
Time Frame
48 hours
Title
Amount of patient controlled analgesia needed
Time Frame
48 hours
Title
Hospital length of stay
Time Frame
48 hours
Title
Patient satisfaction with pain relief
Time Frame
48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy T Wright, MD FRCOG
Organizational Affiliation
Ashford and St Peter's Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ashford and St Peter's Hospitals NHS Foundation Trust
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24548730
Citation
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.
Results Reference
derived
Learn more about this trial
Local Anaesthetic Infusion For Laparoscopic Hysterectomy
We'll reach out to this number within 24 hrs