RecruitingPhase 4NCT06719180

Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

A Prospective Randomized Controlled Trial of Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use


Sponsor

MediSys Health Network

Enrollment

100 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • Patients 18 years and older requiring total laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy for benign conditions
  • Presence of malignancy

Exclusion Criteria6

  • 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)

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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


Locations(1)

Flushing Hospital Medical Center

Flushing, New York, United States

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NCT06719180


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