Recruiting

Vaginal Cuff Anesthesia

Sponsor:

MediSys Health Network

Code:

NCT06719180

Conditions

Hysterectomy

Post Operative Analgesia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacain

Saline (NaCl 0,9 %) (placebo)

Study Details

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.

Conditions

Hysterectomy

Post Operative Analgesia

Study ID

NCT06719180

Start date

Dec 1, 2024

Status verified date

Jan, 2025

Completion date

Oct 31, 2025

Anticipated

Primary completion date

Oct 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vaginal Cuff Anesthesia

placebo comparator: Vaginal Cuff Saline

Interventions

Bupivacain

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)

A saline placebo

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Hosam Hanna, MD

(718) 670-5571hhanna@jhmc.org

Locations

Flushing Hospital Medical Center

Recruiting

Flushing, New York, United States, 11355

Contacts

Hosam Hanna, MD

(718) 670-5571hhanna@jhmc.org

More Information

Sponsor

MediSys Health Network

Last update posted

Jan 7, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MediSys Health Network on 2025-01-07.