Intraperitoneal Atomization of Ropivacaine During Gynecologic Laparoscopic Surgery

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

Conditions

• Postoperative Pain

Interventions

DRUG

Ropivacaine

ADMINISTRATION OF STUDY DRUG All surgical port sites will be injected with 2 ml/each study drug prior to trocar insertion Immediately following insufflation the Optispray surgical spray device will be inserted into the abdomen and directed towards the diaphragms, dome of inflated abdomen, bowel peritoneum and surgical dissection site and the study drug will be delivered as an atomized spray in the following volumes: * each subdiaphragmatic area 3.5 ml + 3.5ml * surgical dissection site 3 ml * diffusely across the peritoneal surface (dome of the abdomen and surface of the visible bowel) 7 ml. At the end of the case the remaining medication with be atomized again onto the same areas, using the same volumes. At the end of the case - this process will be repeated with the remaining drug (no repeat port site injections).

DRUG

placebo (normal saline)

ADMINSTRATION OF PLACEBO All surgical port sites will be injected with 2 ml/each placebo prior to trocar insertion Immediately following insufflation the Optispray surgical spray device will be inserted into the abdomen and directed towards the diaphragms, dome of inflated abdomen, bowel peritoneum and surgical dissection site and the placebo will be delivered as an atomized spray in the following volumes: * each subdiaphragmatic area 3.5 ml + 3.5ml * surgical dissection site 3 ml * diffusely across the peritoneal surface (dome of the abdomen and surface of the visible bowel) 7 ml. At the end of the case the remaining placebo with be atomized again onto the same areas, using the same volumes. At the end of the case - this process will be repeated with the remaining placebo (no repeat port site injections).

Sponsors & Collaborators

• University of Padova

  lead OTHER

Principal Investigators

• Carlo Saccardi, M.D., Ph.D. · University of Padova

• Massimo Micaglio, M.D. · Azienda Ospedaliera Padova

• Matteo Parotto, M.D., Ph.D. · University of Padova

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2012-09-30

Countries

• Italy

Study Locations