Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

Phase 4

Recruiting

• Conditions: Hysterectomy; Post Operative Analgesia
• Interventions: Drug: Bupivacain; Other: Saline (NaCl 0,9 %) (placebo)

• Registration Number: NCT06719180
• Lead Sponsor: MediSys Health Network

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-22
• Study Start: 2024-12-01
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal Cuff Anesthesia	Bupivacain	-
Vaginal Cuff Saline	Saline (NaCl 0,9 %) (placebo)	-

Primary Outcome Measures

Name	Time	Method
Milligrams of Morphine Equivalent Used	From enrollment to end of treatment at 4 hours.

Secondary Outcome Measures

Name	Time	Method
Counts of Non-Opioid Analgesics Used	From enrollment to end of treatment at 4 hours.
Patient Change in Pain Score (0-10)	From Baseline to end of treatment at 4 hours	Change in value of pain score, measured on a 0-10 scale.

Trial Locations

Locations (1)

Flushing Hospital Medical Center; 🇺🇸 Flushing, New York, United States