Post Operative Pain
Conditions
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.
Interventions
DRUGBupivacaine
5 mL of 0.5% bupivacaine will be injected into 2 locations bilaterally.
DRUGnormal saline 0.9%
5 mL of 0.9% normal saline will be injected into 2 locations bilaterally.
Sponsors
University of Kansas Medical Center
The Christ Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with improvement in pain, scored on a 10 point numerical pain scale. | 1 year | Improvement is defined as a 25% or lower total pain score on a ten point numerical pain scale compared to placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative care satisfaction scores, graded with a post-operative survey. | 1 year | 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. | 1 year | 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. | 1 year | Length, in hours, of hospital stay between study cohorts. |
Countries
United States
Outcome results
None listed