Clinical trial NCT01512914: Impact of Intraperitonael Nebulization of Local Anesthetic on Postoperative Pain Associated With Laparoscopic Surgery
Official title: Impact of Intraperitonael Nebulization of Local Anesthetic on Postoperative Pain Associated With Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gynecologic Laparoscopic Surgery
Keywords: Gynecologic laparoscopic surgery
Postoperative pain
Nebulization
Ropivacaine
Lead sponsor: San Gerardo Hospital
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: morphine consumption
timeFrame: 24 hours
measure: Unassisted walking time
timeFrame: 24 hours
measure: Hospital stay
timeFrame: between surgery and discharge
measure: hospital morbidity
timeFrame: up to discharge
Other outcomes:
Locations:
city: Monza
country: Italy
facility: San Gerardo Hospital
state: MB
Study officials:
affiliation: San Gerardo Hospital
name: Pablo M Ingelmo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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;91(2):403-7. doi: 10.1097/00000539-200008000-00032.
citation: 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.
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.0b013e318176fa1c.