Postoperative Pain Control Using ON-Q Painbuster Pump
This study has been completed.
Sponsor:
Ashford and St. Peter's Hospitals NHS Trust
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
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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 (Child, Adult, Senior) |
| 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
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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
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 |
| 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 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 September 28, 2016