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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
preoperative instillation of saline 20 ml, nebulization of ropivacaine 1% 3 ml (30 mg) before surgery and nebulization of saline 3 ml after surgery
preoperative instillation of saline 20 ml, preoperative nebulization of saline 3 ml and nebulization of ropivacaine 1% 3 ml (30 mg) after surgery
preoperative instillation of ropivacaine 0,5% 20 ml (100 mg) and nebulization of saline 3 ml before and after surgery
San Gerardo Hospital
Monza, MB, Italy
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.
Time frame: 24 hours
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
Time frame: 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.
Time frame: 24 hours
Hospital stay
We define hospital stay as the elapsed time between surgery and hospital discharge
Time frame: 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.
Time frame: up to discharge
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preoperative instillation of saline 20 ml and nebulization of saline before and after surgery