Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Postoperative Pain Control Using ON-Q Painbuster Pump

This study has been completed.
Information provided by (Responsible Party):
Ashford and St. Peter's Hospitals NHS Trust Identifier:
First received: June 18, 2010
Last updated: November 12, 2013
Last verified: November 2013
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
Intervention Model: Single Group Assignment
Masking: Double Blind (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

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

Primary Outcome Measures:
  • Rescue analgesia use [ Time Frame: 48 hours ]
    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 ]
    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


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

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 identifier: NCT01184794

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
Principal Investigator: Jeremy T Wright, MD Ashford and St. Peter's Hospitals NHS Trust
  More Information

Responsible Party: Ashford and St. Peter's Hospitals NHS Trust Identifier: NCT01184794     History of Changes
Other Study ID Numbers: 2008JTW01
Study First Received: June 18, 2010
Last Updated: November 12, 2013

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

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 24, 2017