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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

Study 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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with improvement in pain, scored on a 10 point numerical pain scale.
Secondary outcome measures
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.

Find a Location

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
1 Previous Clinical Trials
557 Total Patients Enrolled
Carson T Kaeser, MDPrincipal InvestigatorThe Christ Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.
Carson T. Kaeser, MD 2017. "A Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03067168.
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~16 spots leftby Apr 2025
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