Impact of Intraperitonael Nebulization of Local Anesthetic on Postoperative Pain Associated With Laparoscopic Surgery

San Gerardo Hospital

Status and phase: Completed; Phase 3

Conditions: Gynecologic Laparoscopic Surgery

Treatments: Drug: Ropivacaine 100 mg; Drug: Ropivacaine 30 mg; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01512914

AR HSG 01-2008

Details and patient eligibility

About

Studies evaluating intraperitoneal local anesthetic instillation for pain relief after laparoscopic procedures have provided conflicting results. This randomized, double-blind study was designed to assess the effects of a novel intraperitoneal local anesthetic administration technique using nebulization on pain relief after gynecologic laparoscopic surgery.

Full description

Studies evaluating intraperitoneal local anesthetic (LA) instillation for pain relief after laparoscopic surgery have provided conflicting results. One of the factors that might contribute to failure of the instillation technique may be related to inadequate distribution of local anesthetic throughout the peritoneal surface. In contrast, nebulization should provide a uniform spread of drugs throughout the peritoneal cavity and thus may be beneficial to improve pain relief after laparoscopic procedures. The investigators reported that a microvibration-based nebulization device (Aeroneb Pro® system, Aerogen, Galway, Ireland) could be used for ropivacaine delivery into the insufflation gas required to create pneumorpeitoneum. The investigators hypothesized that intraperitoneal ropivacaine nebulization would provide superior pain relief than ropivacaine instillation after gynecologic laparoscopic surgery. This randomized, double blind, controlled clinical trial was designed to assess the analgesic efficacy of ropivacaine nebulization before or after surgery compared with intraperitoneal ropivacaine instillation and placebo after gynecologic laparoscopic procedures.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females 18-70 years old, ASA score 1 - 3;
• scheduled for laparoscopic operative surgery in the Obstetrics and Gynecology unit;
• free from pain in preoperative period, without habitual analgesic use;
• without cognitive impairment or mental retardation, who gave a written informed consent

Exclusion criteria

• Females under 18 or over 70;
• ASA 4 or 5;
• emergency/urgency criteria, postoperative admission in a intensive care unit with sedation or ventilatory assistance; cognitive impairment or mental retardation;
• habitual analgesic use; progressive degenerative diseases of the CNS;
• convulsions or chronic therapy with antiepileptic drugs;
• severe hepatic or renal impairment;
• pregnancy or lactation;
• allergy to one of the specific substances used in the study;
• acute infectious disease or inflammatory chronic disease, alcohol or drug addiction;
• any kind of communication problem;
• neurologic or psychiatric disease;
• no written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

CONTROL group

Placebo Comparator group

Treatment:

Drug: saline

PREOPERATIVE nebulization

Experimental group

Treatment:

Drug: Ropivacaine 30 mg

Drug: Ropivacaine 30 mg

POSTOPERATIVE nebulization

Experimental group

Treatment:

Drug: Ropivacaine 30 mg

Drug: Ropivacaine 30 mg

INSTILLATION group

Active Comparator group

Treatment:

Drug: Ropivacaine 100 mg