Hysterectomy, Post Operative Analgesia
Conditions
Brief summary
The purpose of this study is to determine whether an injection of a local anesthetic (Bupivacaine with epinephrine) in the vaginal cuff prior to closure would result in less immediate postoperative pain medication and increase patient comfort/satisfaction.
Interventions
DRUGBupivacain
Injection into the vaginal cuff will occur before vaginal cuff closure with stratafix suture. There will be four points of injection 1cm from the edges of the vaginal cuff with a sterilized needle to a depth of 3-4cm. 5cc of bupivacaine with epinephrine or 5cc of normal saline will be injected into each area
OTHERSaline (NaCl 0,9 %) (placebo)
A saline placebo
Sponsors
MediSys Health Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years and older requiring total laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy for benign conditions * Presence of malignancy
Exclusion criteria
* Conversion to laparotomy * Previous multiple abdominal and/or pelvic surgeries * Significant medical comorbidities or cardiac history * Poor initial Aldrete score4 (\<10) * Significant pre-op pain medication use * Contraindication to any medication that would be used in the study (Bupivacaine, epinephrine, tramadol or oxycodone)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Milligrams of Morphine Equivalent Used | From enrollment to end of treatment at 4 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Counts of Non-Opioid Analgesics Used | From enrollment to end of treatment at 4 hours. | — |
| Patient Change in Pain Score (0-10) | From Baseline to end of treatment at 4 hours | Change in value of pain score, measured on a 0-10 scale. |
Countries
United States
Contacts
Primary ContactHosam Hanna, MD
Outcome results
None listed