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

Gynecologic Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512914
• Other study ID #: AR HSG 01-2008
• Status: Completed
• Phase: Phase 3
• First received: January 15, 2012
• Last updated: January 18, 2012
• Start date: May 2008
• Est. completion date: September 2009

Study information

• Verified date: January 2012
• Source: San Gerardo Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gynecologic Laparoscopic Surgery
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine 30 mg
preoperative instillation of saline 20 ml, nebulization of ropivacaine 1% 3 ml (30 mg) before surgery and nebulization of saline 3 ml after surgery
• Ropivacaine 30 mg
preoperative instillation of saline 20 ml, preoperative nebulization of saline 3 ml and nebulization of ropivacaine 1% 3 ml (30 mg) after surgery
• Ropivacaine 100 mg
preoperative instillation of ropivacaine 0,5% 20 ml (100 mg) and nebulization of saline 3 ml before and after surgery
• saline
preoperative instillation of saline 20 ml and nebulization of saline before and after surgery

Locations

Country	Name	City	State
Italy	San Gerardo Hospital	Monza	MB

Sponsors (1)

Lead Sponsor	Collaborator
San Gerardo Hospital

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 — View Citation

Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug; — 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.0b013 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	Postoperative pain was assessed by NRS (0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS). The proportion of patients with adequate pain control after surgery (dynamic NRS < 3) will also be assessed.	24 hours	No
Secondary	morphine consumption	The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display	24 hours	No
Secondary	Unassisted walking time	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.	24 hours	No
Secondary	Hospital stay	We define hospital stay as the elapsed time between surgery and hospital discharge	between surgery and discharge	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, surgical database.	up to discharge	No