Local Anaesthetic Infusion For Laparoscopic Hysterectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ashford and St. Peter's Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01291147
First received: February 4, 2011
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Drug: Levobupivicaine
Drug: 0.9% Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Local Anaesthetic Infusion For Laparoscopic Hysterectomy: A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ashford and St. Peter's Hospitals NHS Trust:

Primary Outcome Measures:
  • • Need for 'rescue' analgesia [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Pain intensity [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Side effects from rescue analgesia [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Amount of patient controlled analgesia needed [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Patient satisfaction with pain relief [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2011
Study Completion Date: February 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01291147

Locations
United Kingdom
Ashford and St Peter's Hospitals NHS Foundation Trust
Chertsey, Surrey, United Kingdom, KT16 0PZ
Sponsors and Collaborators
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
  More Information

No publications provided by Ashford and St. Peter's Hospitals NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ashford and St. Peter's Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01291147     History of Changes
Other Study ID Numbers: 2010JTW01
Study First Received: February 4, 2011
Last Updated: November 12, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Ashford and St. Peter's Hospitals NHS Trust:
pain
anaesthetic

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Levobupivacaine
Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014