Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

Part of paid clinical trials in Flushing, New York.

Sponsor
MediSys Health Network
Study ID
NCT06719180
Phase
PHASE4
Status
Recruiting
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Conditions

  • Hysterectomy
  • Post Operative Analgesia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bupivacain — DRUG
    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
  • Saline (NaCl 0,9 %) (placebo) — OTHER
    A saline placebo

Study Details

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.

Key Dates

Start date
Dec 1, 2024
Status verified
Jan 2025
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vaginal Cuff Anesthesia
  • Placebo Comparator: Vaginal Cuff Saline

Primary Outcome Measure

Milligrams of Morphine Equivalent Used [ Time Frame: From enrollment to end of treatment at 4 hours. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Flushing Hospital Medical CenterFlushingNew York11355
Hosam Hanna, MD
[email protected]
(718) 670-5571

Find similar trials in Flushing, NY

By research site
Flushing Hospital Medical Center· Flushing, NY

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