Back to resultsA Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.
Primary Purpose
Post Operative Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
normal saline 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Any woman who is a non-English speaker, does not have ability to provide consent, has a cardiac arrhythmia, liver disease, myasthenia gravis, bleeding diathesis or adverse reaction / allergy to anesthetic will be excluded. Women that are also having vaginal mesh excisions at the time of prolapse repair or those that will undergo subsequent surgery in the follow up period will be excluded.
Sites / Locations
- The University of Kansas Medical Center
- The Christ Hospital
- The University of Toledo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Bupivacaine Arm
Placebo Arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of patients with improvement in pain, scored on a 10 point numerical pain scale.
Improvement is defined as a 25% or lower total pain score on a ten point numerical pain scale compared to placebo.
Secondary Outcome Measures
Postoperative care satisfaction scores, graded with a post-operative survey.
Improvement in satisfaction is defined as an overall satisfaction score of 20% or more on the post-operative survey compared to placebo.
Measure of morphine equivalents used in patients postoperatively.
A reduction in opiate use is defined as a 20% reduction in total number of morphine equivalents used between study cohorts.
Length of hospital stay measured in hours.
Length, in hours, of hospital stay between study cohorts.
Full Information
NCT ID
NCT03067168
First Posted
February 17, 2017
Last Updated
January 3, 2019
Sponsor
The Christ Hospital
Collaborators
The University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03067168
Brief Title
A Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.
Official Title
A Multicenter, Double Blinded, Randomized Controlled Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Christ Hospital
Collaborators
The University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Subjects will not know if they received an injection of bupivacaine or placebo, i.e., normal saline after completion of surgery. The surgeon, as well as any investigator or study personnel, will be blinded to injection type.
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
5 mL of 0.5% bupivacaine will be injected into 2 locations bilaterally.
Intervention Type
Drug
Intervention Name(s)
normal saline 0.9%
Other Intervention Name(s)
Saline
Intervention Description
5 mL of 0.9% normal saline will be injected into 2 locations bilaterally.
Primary Outcome Measure Information:
Title
Number of patients with improvement in pain, scored on a 10 point numerical pain scale.
Description
Improvement is defined as a 25% or lower total pain score on a ten point numerical pain scale compared to placebo.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Postoperative care satisfaction scores, graded with a post-operative survey.
Description
Improvement in satisfaction is defined as an overall satisfaction score of 20% or more on the post-operative survey compared to placebo.
Time Frame
1 year
Title
Measure of morphine equivalents used in patients postoperatively.
Description
A reduction in opiate use is defined as a 20% reduction in total number of morphine equivalents used between study cohorts.
Time Frame
1 year
Title
Length of hospital stay measured in hours.
Description
Length, in hours, of hospital stay between study cohorts.
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients that are eligible would be undergoing vaginal prolapse surgery including posterior colporrhaphy, therefore would need to have a vagina to be enrolled in this study
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Any woman who is a non-English speaker, does not have ability to provide consent, has a cardiac arrhythmia, liver disease, myasthenia gravis, bleeding diathesis or adverse reaction / allergy to anesthetic will be excluded. Women that are also having vaginal mesh excisions at the time of prolapse repair or those that will undergo subsequent surgery in the follow up period will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carson T Kaeser, MD
Organizational Affiliation
The Christ Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34171880
Citation
Kaeser CT, Rothenberger R, Zoorob D, Whiteside JL. Bupivacaine Use After Posterior Colporrhaphy to Reduce Postoperative Pain: A Multicenter, Double-Blinded, Placebo-Controlled, Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2022 Feb 1;28(2):72-76. doi: 10.1097/SPV.0000000000001082.
Results Reference
derived
Learn more about this trial
A Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.
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