Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery

Ovarian Cysts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142622
• Other study ID #: AR HSG 02 2010 Ovarian Cyst
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2010
• Last updated: February 22, 2013
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: San Gerardo Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cysts

Intervention

Drug:
• Ropivacaine nebulization
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity.
• Ropivacaine instillation
Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity.

Locations

Country	Name	City	State
Italy	San Gerardo Hospital	Monza	MB

Sponsors (2)

Lead Sponsor	Collaborator
San Gerardo Hospital	A.O. Ospedale Papa Giovanni XXIII

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. Epub 2006 Dec 16. — View Citation

Greib N, Schlotterbeck H, Dow WA, Joshi GP, Geny B, Diemunsch PA. An evaluation of gas humidifying devices as a means of intraperitoneal local anesthetic administration for laparoscopic surgery. Anesth Analg. 2008 Aug;107(2):549-51. doi: 10.1213/ane.0b013e318176fa1c. — View Citation

Schlotterbeck H, Schaeffer R, Dow WA, Diemunsch P. Cold nebulization used to prevent heat loss during laparoscopic surgery: an experimental study in pigs. Surg Endosc. 2008 Dec;22(12):2616-20. doi: 10.1007/s00464-008-9841-z. Epub 2008 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption (mg)	The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display.	Up to 24 hours	No
Secondary	Postoperative Pain	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.	Up to 24 hours	No
Secondary	Time of unassisted walking	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.	Up to 24 hours	No
Secondary	Hospital morbidity	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.	Up to 24 hours	Yes
Secondary	Hospital stay	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).	Up to 24 hours	No
Secondary	Quality of life after surgery	Quality of life will be assessed using the SF-36 questionnaire	Four weeks after surgery	No