Local anesthetic injection to reduce pain after hysterectomy
A Prospective Randomized Controlled Trial of Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use
This study tests if injecting a local anesthetic into the vaginal cuff during a hysterectomy can help reduce pain after surgery and lower the need for pain medication for patients having the procedure for non-cancerous reasons.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | MediSys Health Network Academic / other |
| Locations | 1 site (Flushing, New York) |
| Trial ID | NCT06719180 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of injecting a local anesthetic, Bupivacaine with epinephrine, into the vaginal cuff before closing after a total laparoscopic hysterectomy. The aim is to assess whether this intervention can lead to reduced immediate postoperative pain and lower the need for pain medication, thereby enhancing patient comfort and satisfaction. The study will compare outcomes between patients receiving the anesthetic and those receiving a saline placebo. It targets patients undergoing hysterectomy for benign conditions.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 and older who require a total laparoscopic hysterectomy for benign conditions.
Not a fit: Patients who have undergone multiple previous abdominal or pelvic surgeries or have significant medical comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and improve recovery experiences for patients undergoing hysterectomy.
How similar studies have performed: Other studies have shown promising results with local anesthetic use in postoperative pain management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Flushing, New York
- Flushing Hospital Medical Center — Flushing, New York, United States (Recruiting)
Study contacts
- Study coordinator: Hosam Hanna, MD
- Email: hhanna@jhmc.org
- Phone: (718) 670-5571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.