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

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 |
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
|
- Rescue analgesia use [ Time Frame: 48 hours ]participants will record number of doses of oral analgesic tablets they required.
- Pain intensity on movement and rest [ Time Frame: 48 hours ]participants are asked to complete a 10 point ranked ordinal pain score

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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 |
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.

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
United Kingdom | |
Ashford & St Peter's Hospitals NHS Trust | |
Chertsey, Surrey, United Kingdom, KT16 0PZ |
Principal Investigator: | Jeremy T Wright, MD | Ashford and St. Peter's Hospitals NHS Trust |
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 |