Back to resultsPost-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair
Primary Purpose
Post-Operative Pain, Pelvic Organ Prolapse
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Continuous bupivacaine analgesia infusion (ON-Q PainBuster Post-Op Pain Relief System)
Sponsored by
About this trial
This is an interventional treatment trial for Post-Operative Pain focused on measuring Continuous bupivacaine infusion, Analgesia
Eligibility Criteria
Inclusion Criteria:
- Female patients greater than 18 years of age
- Undergoing posterior colporrhaphy at Saint Lukes Hospital, Kansas City, MO.
Exclusion Criteria:
- Patients with chronic pain conditions requiring daily narcotics were excluded
Sites / Locations
- St. Luke's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bupiv analgesia
Arm Description
Patients assigned to the study group had an ON-Q PainBuster Post-Op Pain Relief System (270 ml x 4 ml/hr, dual catheter, 2 ml per site, 72 hours continuous) with dual five inch fenestrated catheters placed at the sacrospinous ligament. The catheter was placed in the operating room with a peel-away trocar and attached to the pump. The trocar was inserted through a 5 mm stab incision made near the superior part of the pubic bone between the genitoinguinal fold and the midline of the symphysis. Once through the incision, the trocar is advanced subcutaneously and made to exit the posterior fourchette just beneath the posterior vaginal mucosa where it is advanced by tenting up the skin.
Outcomes
Primary Outcome Measures
The primary outcome was a difference in the Wisconsin Brief Pain Inventory and Visual Acuity Score after treatment with the direct continuous analgesia device compared to PCA alone.
Secondary Outcome Measures
Secondary outcome was differences in the amount of narcotics, NSAIDS, antiemetics, time to return of bladder function, and complications between the study groups.
Full Information
NCT ID
NCT00695240
First Posted
June 9, 2008
Last Updated
June 10, 2008
Sponsor
St. Luke's Hospital, Kansas City, Missouri
1. Study Identification
Unique Protocol Identification Number
NCT00695240
Brief Title
Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair
Official Title
Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
St. Luke's Hospital, Kansas City, Missouri
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This prospective randomized controlled study will determine the efficacy of continuous local anesthesia at decreasing pain scores compared to patient controlled analgesia for pelvic organ prolapse procedures including posterior colporrhaphy and sacrospinous ligament fixation.
Detailed Description
Direct post-operative analgesia can be administered via a direct continuous analgesia pumps providing local anesthetic into a dissected area. To date, no studies have been conducted to evaluate pain control or infection with vaginal placement of catheters for pelvic organ prolapse surgery. To help pelvic surgeons assess the relative benefit of continuous local infusion of topical anesthetic following sacrospinous ligament fixation versus PCA pump, we compared pain scores, narcotic, anti-pruritic and anti-emetic drug usage, and wound complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Pain, Pelvic Organ Prolapse
Keywords
Continuous bupivacaine infusion, Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bupiv analgesia
Arm Type
Experimental
Arm Description
Patients assigned to the study group had an ON-Q PainBuster Post-Op Pain Relief System (270 ml x 4 ml/hr, dual catheter, 2 ml per site, 72 hours continuous) with dual five inch fenestrated catheters placed at the sacrospinous ligament. The catheter was placed in the operating room with a peel-away trocar and attached to the pump. The trocar was inserted through a 5 mm stab incision made near the superior part of the pubic bone between the genitoinguinal fold and the midline of the symphysis. Once through the incision, the trocar is advanced subcutaneously and made to exit the posterior fourchette just beneath the posterior vaginal mucosa where it is advanced by tenting up the skin.
Intervention Type
Device
Intervention Name(s)
Continuous bupivacaine analgesia infusion (ON-Q PainBuster Post-Op Pain Relief System)
Other Intervention Name(s)
ON-Q PainBuster Post-Op Pain Relief System
Intervention Description
Patients assigned to the study group had an ON-Q PainBuster Post-Op Pain Relief System (270 ml x 4 ml/hr, dual catheter, 2 ml per site, 72 hours continuous) with dual five inch fenestrated catheters placed at the sacrospinous ligament. One half percent bupivacaine was utilized.
Primary Outcome Measure Information:
Title
The primary outcome was a difference in the Wisconsin Brief Pain Inventory and Visual Acuity Score after treatment with the direct continuous analgesia device compared to PCA alone.
Time Frame
Each day post-operatively
Secondary Outcome Measure Information:
Title
Secondary outcome was differences in the amount of narcotics, NSAIDS, antiemetics, time to return of bladder function, and complications between the study groups.
Time Frame
Each day post-operatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female patients greater than 18 years of age
Undergoing posterior colporrhaphy at Saint Lukes Hospital, Kansas City, MO.
Exclusion Criteria:
Patients with chronic pain conditions requiring daily narcotics were excluded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tyler M Muffly, MD
Phone
816-404-1000
Email
tylermuffly@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Hill, MD
Phone
816-932-1758
Email
rihill@saint-lukes.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyler M Muffly, MD
Organizational Affiliation
St. Luke's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tyler Muffly, MD
Phone
816-404-1000
Email
tylermuffly@hotmail.com
First Name & Middle Initial & Last Name & Degree
Tyler Muffly, MD
12. IPD Sharing Statement
Learn more about this trial
Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair
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