Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery

S

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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