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Recruiting Phase 4 NCT06719180

NCT06719180 Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

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Clinical Trial Summary
NCT ID NCT06719180
Status Recruiting
Phase Phase 4
Sponsor MediSys Health Network
Condition Hysterectomy
Study Type INTERVENTIONAL
Enrollment 100 participants
Start Date 2024-12-01
Primary Completion 2025-10-31

Trial Parameters

Condition Hysterectomy
Sponsor MediSys Health Network
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 100
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-12-01
Completion 2025-10-31
Interventions
BupivacainSaline (NaCl 0,9 %) (placebo)

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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.

Eligibility Criteria

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)

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