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NCT Number: NCT06719180

Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

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.

Recruiting

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Key information

Conditions

Hysterectomy Post Operative Analgesia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Flushing Hospital Medical Center

Flushing, New York, 11355, United States

Location status: Recruiting

Location contact

Hosam Hanna, MD

CONTACT

[email protected]

(718) 670-5571

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Milligrams of Morphine Equivalent Used

    Time frame: From enrollment to end of treatment at 4 hours.

Secondary outcomes

  1. Counts of Non-Opioid Analgesics Used

    Time frame: From enrollment to end of treatment at 4 hours.

  2. Patient Change in Pain Score (0-10)

    Time frame: From Baseline to end of treatment at 4 hours

    Change in value of pain score, measured on a 0-10 scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Hosam Hanna, MD

CONTACT

[email protected]

(718) 670-5571

Sponsors and collaborators

Lead sponsor

MediSys Health Network

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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