Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery

San Gerardo Hospital

Status and phase: Completed; Phase 3

Conditions: Ovarian Cysts

Treatments: Drug: Ropivacaine instillation; Drug: Ropivacaine nebulization

Study type: Interventional

Funder types: Other

Identifiers

NCT01142622

AR HSG 02 2010 Ovarian Cyst

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

Ropivacaine nebulization

Experimental group

Description:

Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity

Treatment:

Drug: Ropivacaine nebulization

Ropivacaine instillation

Active Comparator group

Description:

Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity before surgery

Treatment:

Drug: Ropivacaine instillation