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

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

Sponsors

Lead Sponsor: San Gerardo Hospital

Source San Gerardo Hospital
Brief Summary

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.

Detailed 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.

Overall Status Completed
Start Date May 2008
Completion Date September 2009
Primary Completion Date September 2009
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
postoperative pain 24 hours
Secondary Outcome
Measure Time Frame
morphine consumption 24 hours
Unassisted walking time 24 hours
Hospital stay between surgery and discharge
hospital morbidity up to discharge
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ropivacaine 30 mg

Description: preoperative instillation of saline 20 ml, nebulization of ropivacaine 1% 3 ml (30 mg) before surgery and nebulization of saline 3 ml after surgery

Arm Group Label: PREOPERATIVE nebulization

Intervention Type: Drug

Intervention Name: Ropivacaine 30 mg

Description: preoperative instillation of saline 20 ml, preoperative nebulization of saline 3 ml and nebulization of ropivacaine 1% 3 ml (30 mg) after surgery

Arm Group Label: POSTOPERATIVE nebulization

Intervention Type: Drug

Intervention Name: Ropivacaine 100 mg

Description: preoperative instillation of ropivacaine 0,5% 20 ml (100 mg) and nebulization of saline 3 ml before and after surgery

Arm Group Label: INSTILLATION group

Intervention Type: Drug

Intervention Name: saline

Description: preoperative instillation of saline 20 ml and nebulization of saline before and after surgery

Arm Group Label: CONTROL group

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pablo M Ingelmo, MD Principal Investigator San Gerardo Hospital
Location
Facility: San Gerardo Hospital
Location Countries

Italy

Verification Date

January 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: San Gerardo Hospital

Investigator Full Name: Pablo Mauricio Ingelmo M.D.

Investigator Title: MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: CONTROL group

Type: Placebo Comparator

Label: PREOPERATIVE nebulization

Type: Experimental

Label: POSTOPERATIVE nebulization

Type: Experimental

Label: INSTILLATION group

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov