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Postoperative Pain Control Using ON-Q Painbuster Pump

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ClinicalTrials.gov Identifier: NCT01184794
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
Ashford and St. Peter's Hospitals NHS Trust

Study Description
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Brief Summary:
This study is a blinded randomised study of slow release levobupivacaine vs saline for women undergoing day case operative pelvic laparoscopy. Participants will be randomly given either saline or levobupivacaine and efficacy will be measured using ranked ordinal pain scales and rescue oral analgesia use.

Condition or disease Intervention/treatment Phase
Post Operative Analgesia Drug: levobupivacaine Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Pain Control Using Continuous Infusion of Levobupivacaine in Women Undergoing Pelvic Operative Laparoscopy: A Randomised Controlled Trial
Study Start Date : August 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Saline
Placebo solution
 Drug: levobupivacaine
40 ml over 48 hours
Other Name: Chirocaine
Experimental: levobupivacaine, analgesia
Active drug
 Drug: levobupivacaine
40 ml over 48 hours
Other Name: Chirocaine


Outcome Measures
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Primary Outcome Measures :
  1. Rescue analgesia use [ Time Frame: 48 hours ]
    participants will record number of doses of oral analgesic tablets they required.


Secondary Outcome Measures :
  1. Pain intensity on movement and rest [ Time Frame: 48 hours ]
    participants are asked to complete a 10 point ranked ordinal pain score


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women undergoing 'Day case' operative laparoscopic procedures.
  • These women are deemed suitable to return home on the day of surgery, both in terms of physical fitness and their home circumstances.

Exclusion Criteria:

  • Women having laparoscopic procedures for diagnostic purposes or minor operations such as sterilisation, will be excluded from the study.
  • These procedures are less likely to cause significant pain due to operation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184794


Locations
United Kingdom
Ashford & St Peter's Hospitals NHS 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 Ashford and St. Peter's Hospitals NHS Trust
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Ashford and St. Peter's Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01184794     History of Changes
Other Study ID Numbers: 2008JTW01
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Ashford and St. Peter's Hospitals NHS Trust:
Analgesia laparoscopy

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