Intraperitoneal Atomization of Ropivacaine During Gynecologic Laparoscopic Surgery

NCT01623635 | Unknown Phase 3

• 1 other identifier: 2011-004203-20
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Post-operative pain intensity

  NRS score. (NRS; 0 = no pain and 10 = worse pain possible)at 6 hours post-operatively

  at 6h post-operatively

Secondary Outcomes (1)

• Total post-operative opioid analgesic requirements

  in the first 48 hours post-operatively or until discharge

Study Arms (4)

Case - adnexal

EXPERIMENTAL

Drug: Ropivacaine

placebo - adnexal

PLACEBO COMPARATOR

Drug: placebo (normal saline)

case - uterine

EXPERIMENTAL

Drug: Ropivacaine

placebo - uterine

PLACEBO COMPARATOR

Drug: placebo (normal saline)

Interventions

Ropivacaine DRUG

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).

Case - adnexal; case - uterine

placebo (normal saline) DRUG

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).

placebo - adnexal; placebo - uterine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Azienda Ospedaliera-Università Padova

Padua, Padova, 35128, Italy

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Carlo Saccardi, M.D., Ph.D.

  University of Padova

  PRINCIPAL INVESTIGATOR

• Massimo Micaglio, M.D.

  Azienda Ospedaliera Padova

  PRINCIPAL INVESTIGATOR

• Matteo Parotto, M.D., Ph.D.

  University of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Saccardi, M.D., Ph.D.

CONTACT

+39.049.8218524; carlo.saccardi@unipd.it

Massimo MIcaglio, M.D.

CONTACT

+39.049.8213454; m.micaglio@libero.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: June 20, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2012
• Last Updated: June 20, 2012

Record last verified: 2012-02

Locations

IT (1)