Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

MediSys Health Network

Status and phase: Enrolling; Phase 4

Conditions: Post Operative Analgesia; Hysterectomy

Treatments: Other: Saline (NaCl 0,9 %) (placebo); Drug: Bupivacain

Study type: Interventional

Funder types: Other

Identifiers

NCT06719180

2172359

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

100 participants in 2 patient groups, including a placebo group

Vaginal Cuff Anesthesia

Experimental group

Treatment:

Drug: Bupivacain

Vaginal Cuff Saline

Placebo Comparator group

Treatment:

Other: Saline (NaCl 0,9 %) (placebo)