Recruiting NCT06719180
Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacain, Saline (NaCl 0,9 %) (placebo).
- Who it may be relevant to
- Registry conditions: Hysterectomy, Post Operative Analgesia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Randomized Controlled Trial of Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use
Overview
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.
Interventions
- Drug 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 - Other Saline (NaCl 0,9 %) (placebo)
A saline placebo
Primary outcome measures
- Milligrams of Morphine Equivalent Used [Time frame: From enrollment to end of treatment at 4 hours.]
Secondary outcome measures (2)
- Counts of Non-Opioid Analgesics Used [Time frame: From enrollment to end of treatment at 4 hours.]
- Patient Change in Pain Score (0-10) [Time frame: From Baseline to end of treatment at 4 hours]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Flushing Hospital Medical Center — Flushing
Identifiers
NCT: NCT06719180 · 2172359