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Completed

NCT Number: NCT01142622

Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery

The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg may prevent the use of morphine during the first day after laparoscopic ovarian cyst surgery.

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Key information

Conditions

Ovarian Cysts Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Diseases Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

San Gerardo Hospital

Monza, MB, 20052, Italy

About this study

In a recent study the investigators found that nebulization of Ropivacaine 30 mg before or after gynaecologic laparoscopic surgery significantly reduces postoperative pain and postoperative morphine consumption.

Ropivacaine was effectively administered with non-heating nebulizers (AeronebPro®).

However, almost all patients still use morphine after surgery.

The investigators hypothesize that intraperitoneal nebulization of Ropivacaine 150 mg may prevent the use of morphine after the laparoscopic ovarian cyst surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females 18-65 years old
  • ASA Score I-III
  • Scheduled for ovarian cyst laparoscopic surgery
  • Free from pain in preoperative period
  • Not using analgesic drugs before surgery
  • Without cognitive impairment or mental retardation
  • Written informed consent

Exclusion criteria

  • Emergency/urgency surgery
  • Postoperative admission in an intensive care unit
  • Cognitive impairment or mental retardation
  • Progressive degenerative diseases of the CNS
  • Seizures or chronic therapy with antiepileptic drugs
  • Severe hepatic or renal impairment
  • Pregnancy or lactation
  • Allergy to one of the specific drugs under study
  • Acute infection or inflammatory chronic disease
  • Alcohol or drug addiction

Treatment and study plan

Ropivacaine nebulization

Drug

Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity.

Other names: Ropivacaine, Nebulization

Ropivacaine instillation

Drug

Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity.

Other names: Ropivacaine, Instillation

Primary outcomes

  1. Morphine consumption (mg)

    Time frame: Up to 24 hours

    The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display.

Secondary outcomes

  1. Postoperative Pain

    Time frame: Up to 24 hours

    Postoperative pain will be assessed by numeric ranking scale (NRS 0 to 10 points) at rest (static NRS) and after deep inspiration or cough (dynamic NRS). Pain after surgery will be differentiated as abdominal, wall pain, port wound pain, back pain and shoulder pain. The proportion of patients with adequate pain control after surgery (dynamic NRS < 3) will also be assessed.

  2. Time of unassisted walking

    Time frame: Up to 24 hours

    Unassisted walking time is defined as the time in hours between PACU discharge and when the patient is able to walk out of his room and back to bed without any assistance.

  3. Hospital morbidity

    Time frame: Up to 24 hours

    All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia, will be quantified using the anesthesia charts, surgical charts and surgical database.

  4. Hospital stay

    Time frame: Up to 24 hours

    We define hospital stay as the time in hours elapsed between surgery and hospital discharge. We evaluate the hospital stay with the post-anesthetic discharge scoring system (Modified-PADSS).

  5. Quality of life after surgery

    Time frame: Four weeks after surgery

    Quality of life will be assessed using the SF-36 questionnaire

Sponsors and collaborators

Lead sponsor

San Gerardo Hospital

Other

Collaborators

  • A.O. Ospedale Papa Giovanni XXIII

Registry information

Official study title

Do Peritoneal Nebulization of Ropivacaine Reduce the Use of Morphine After Short Gynecologic Laparoscopic Surgery?

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 11, 2010
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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