Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMediSys Health Network
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18 years and older requiring total laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy for benign conditions
Presence of malignancy
Disqualifiers
Conversion to laparotomy
Previous multiple abdominal and/or pelvic surgeries
Significant medical comorbidities or cardiac history
Poor initial Aldrete score4 (<10)
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacain
DrugInjection 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
Saline (NaCl 0,9 %) (placebo)
Other interventionA saline placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Vaginal Cuff AnesthesiaExperimental treatment 1 intervention
Group B: Vaginal Cuff SalinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Milligrams of Morphine Equivalent Used
Time frame
From enrollment to end of treatment at 4 hours.Secondary outcomes
1
Counts of Non-Opioid Analgesics Used
Time frame
From enrollment to end of treatment at 4 hours.2
Patient Change in Pain Score (0-10)
Change in value of pain score, measured on a 0-10 scale.
Time frame
From Baseline to end of treatment at 4 hoursSponsors and contacts
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Source ClinicalTrials.gov