Vaginal Cuff Anesthesia for Post-Hysterectomy Pain

This study is looking at whether injecting a local anesthetic called Bupivacaine (with epinephrine) into the vaginal cuff during a hysterectomy (surgery to remove the uterus) can reduce the amount of pain medication you need right after surgery and make you more comfortable. Researchers will compare Bupivacaine to a saline (saltwater) placebo. You might be able to join if you are 18 or older, need a total laparoscopic hysterectomy for benign (non-cancerous) conditions or have malignancy (cancer). The study aims to see if Bupivacaine leads to less pain medication use within the first four hours after surgery. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 100 women. It compares Bupivacaine to a saline placebo, meaning some participants will receive the active drug and others will receive an inactive substance.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Pain medication use will be measured from enrollment to the end of treatment at 4 hours.

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NCT06719180

Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

Recruiting
PHASE4Ages 18+InterventionalTreatment
MediSys Health Network
~100 participants
Updated 2025-01-07 on ClinicalTrials.gov
What's tested:BupivacainSaline (NaCl 0,9 %) (placebo)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Milligrams of Morphine Equivalent Used
Measured over From enrollment to end of treatment at 4 hours.
Hysterectomy
Post Operative Analgesia
1 sites across 1 states
New York1

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Eligibility criteria

Inclusion

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

Exclusion

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)
  • Milligrams of Morphine Equivalent UsedFrom enrollment to end of treatment at 4 hours.