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Bupivacaine Arm for Postoperative Pain
N/A
Waitlist Available
Led By Carson T Kaeser, MD
Research Sponsored by The Christ Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Any woman over the age of 18 years with a capacity to give informed consent who are undergoing vaginal prolapse surgery including a posterior colporrhaphy may be included in the study.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
To determine if levator muscle block with bupivacaine improves postoperative pain control relative to placebo controls among women undergoing prolapse surgery involving a posterior colporrhaphy. Improvement is defined as no less than a 25% lower total pain score on a ten point numerical pain scale.
Eligible Conditions
- Postoperative Pain
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of patients with improvement in pain, scored on a 10 point numerical pain scale.
Secondary study objectives
Length of hospital stay measured in hours.
Measure of morphine equivalents used in patients postoperatively.
Postoperative care satisfaction scores, graded with a post-operative survey.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Bupivacaine ArmActive Control1 Intervention
The subjects of this arm will receive an injection of 5mL of 0.5% bupivacaine, 1-2 cm deep to the surface of the vaginal epithelium into the levator ani muscle, puborectalis. A second injection of 5mL of 0.5% bupivacaine, 1-2 cm deep to the surface of the vaginal epithelium will be repeated on the same side, approximately 2-3 cm cephalad of the first injection at the iliococcygeus muscle. These 2 injections will then be repeated on the contralateral side.
Group II: Placebo ArmPlacebo Group1 Intervention
The subjects of this arm will receive an injection of 5mL of 0.9% normal saline, 1-2 cm deep to the surface of the vaginal epithelium into the levator ani muscle, puborectalis. A second injection of 0.9% normal saline, 1-2 cm deep to the surface of the vaginal epithelium will be repeated on the same side, approximately 2-3 cm cephalic from first injection at the iliococcygeus muscle. These 2 injections will then be repeated on the contralateral side.
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Who is running the clinical trial?
The Christ HospitalLead Sponsor
19 Previous Clinical Trials
1,265 Total Patients Enrolled
The University of Kansas Medical CenterUNKNOWN
2 Previous Clinical Trials
742 Total Patients Enrolled
Carson T Kaeser, MDPrincipal InvestigatorThe Christ Hospital
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