Intraperitoneal Atomization of Ropivacaine During Gynecologic Laparoscopic Surgery

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Pain following laparoscopic surgery continues to be a clinically important problem with 80% or more patients requiring opioid analgesia post-operatively to control their pain. By reducing this surgical complication patients can experience less discomfort and be discharged from the recovery room more rapidly leading to reduced resource utilization and expense.

HYPOTHESIS: Post-operative pain after laparoscopic procedures could be treated by topical anesthetics sprayed directly into the abdomen (inside the abdominal cavity, on the nerve endings of the visceral peritoneal lining and diaphragm surface) via the surgical incision METHODS: Randomized controlled trial on use of topical anesthetic (namely 0.25% ropivacaine) delivered directly onto the target sites both at the beginning and the end of surgery in patients undergoing laparoscopic gynecologic procedure for uterine or adnexal benign pathology. The drug will be delivered using a CE approved delivery system that will direct a fine mist of drug directly to the areas of the peritoneal cavity that are theoretically the cause of post-op pain (diaphragms, peritoneal abdominal surface, surgical dissection site).

GOAL: to assess the efficacy of intraperitoneal topical anesthesia in reducing postoperative pain, opioid requirements in patients undergoing laparoscopic gynecologic procedure for uterine or adnexal benign pathology

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Padova
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

• Patients undergoing elective laparoscopic surgical intervention for benign uterine or adnexal conditions

Exclusion Criteria:

• Less than 18 year old

• Pregnancy

• Prisoners

• Allergic/contraindications to topical anesthetics (Amides specifically)

• Allergic/contraindications to Opioids as a class

• Allergic/contraindications to acetaminophen

• Allergic/contraindications to Propofol

• Allergic/contraindications to NSAIDS

• Currently or within the last 30 days been prescribed an opiate medication

• History of drugs or alcohol abuse

• Chronic pain syndrome

• Suspected gynecologic malignancy

• Poor comprehension of written and spoken Italian for informed consent purpose