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

History of Changes

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 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

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

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Eligibility


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

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


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

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

ClinicalTrials.gov processed this record on August 23, 2017

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