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

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Laparoscopic Surgery
• Intervention / Treatment: Drug: saline; Drug: Ropivacaine 30 mg; Drug: Ropivacaine 30 mg; Drug: Ropivacaine 100 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • MB
    • Monza, MB, Italy, 20052
      • San Gerardo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: CONTROL group	Drug: saline; preoperative instillation of saline 20 ml and nebulization of saline before and after surgery
EXPERIMENTAL: PREOPERATIVE nebulization	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; Drug: 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
EXPERIMENTAL: POSTOPERATIVE nebulization	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; Drug: 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
ACTIVE_COMPARATOR: INSTILLATION group	Drug: Ropivacaine 100 mg; preoperative instillation of ropivacaine 0,5% 20 ml (100 mg) and nebulization of saline 3 ml before and after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Hospital stay	We define hospital stay as the elapsed time between surgery and hospital discharge	between surgery and discharge
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

Collaborators and Investigators

• Sponsor: San Gerardo Hospital
• Investigators: Principal Investigator: Pablo M Ingelmo, MD, San Gerardo Hospital

Publications and helpful links

General Publications

• 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. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.
• 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.0b013e318176fa1c.
• 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;91(2):403-7. doi: 10.1097/00000539-200008000-00032.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: January 15, 2012
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (ESTIMATE): January 19, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 19, 2012
• Last Update Submitted That Met QC Criteria: January 18, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Nebulization; Postoperative pain; Ropivacaine; Gynecologic laparoscopic surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: AR HSG 01-2008