Postoperative Pain Control Using ON-Q Painbuster Pump

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ashford and St. Peter's Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01184794
First received: June 18, 2010
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Post Operative Analgesia
Drug: levobupivacaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

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

Primary Outcome Measures:
  • Rescue analgesia use [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    participants will record number of doses of oral analgesic tablets they required.


Secondary Outcome Measures:
  • Pain intensity on movement and rest [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    participants are asked to complete a 10 point ranked ordinal pain score


Enrollment: 60
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ashford and St. Peter's Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01184794     History of Changes
Other Study ID Numbers: 2008JTW01
Study First Received: June 18, 2010
Last Updated: November 12, 2013
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Levobupivacaine
Bupivacaine
Anesthetics, Local
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 22, 2014