Local Anesthetic Nebulization for Pain Control After Laparoscopic Cholecystectomy
- Conditions
- Laparoscopic Cholecystectomy
- Interventions
- Drug: Saline
- Registration Number
- NCT01247857
- Lead Sponsor
- San Gerardo Hospital
- Brief Summary
Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopy. Preoperative compared with postoperative administration of analgesia remains controversial. This randomized, double blind, placebo-controlled trial compared the analgesic efficacy of preoperative with postoperative peritoneal ropivacaine nebulization in patients undergoing elective laparoscopic cholecystectomy.
- Detailed Description
Previous studies evaluating intraperitoneal local anesthetic administration for pain relief after laparoscopic surgery have suggested that the timing of local anesthetic administration may be critical in the success of the technique. A meta-analysis of randomized trials of intraperitoneal local anesthetic instillation in patients undergoing laparoscopic surgery found that local anesthetic instilled before surgical dissection provided superior pain relief compared to instillation at the end of surgery. Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopic surgery. Recently, Alkhamesi et al reported that bupivacaine nebulization performed at the end of laparoscopic cholecystectomy significantly reduced postoperative pain. However, clinical benefits of preoperative administration of analgesia, compared with postoperative administration, remains controversial.
The investigators hypothesized that pain relief after preoperative and postoperative ropivacaine nebulization would be similar but better than placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- ASA Score I-III
- Scheduled for laparoscopic cholecystectomy
- Free from pain in preoperative period
- Not using analgesic drugs before surgery
- Without cognitive impairment or mental retardation
- Written informed consent
- Emergency/urgency surgery
- Postoperative admission in an intensive care unit
- Cognitive impairment or mental retardation
- Progressive degenerative diseases of the CNS
- Seizures or chronic therapy with antiepileptic drugs
- Severe hepatic or renal impairment
- Pregnancy or lactation
- Allergy to one of the specific drugs under study
- Acute infection or inflammatory chronic disease
- Alcohol or drug addiction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preoperative Nebulization Ropivacaine 30 mg Nebulization of 30 mg of Ropivacaine in the peritoneal cavity before surgery Postoperative Nebulization Ropivacaine 30 mg Nebulization of 30 mg of Ropivacaine in the peritoneal cavity after surgery Control Saline Nebulization of normal saline 3 ml before and after surgery
- Primary Outcome Measures
Name Time Method Postoperative Pain 48 hours Postoperative pain will be assessed by numeric ranking scale (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.
- Secondary Outcome Measures
Name Time Method Time of unassisted walking Up to 48 hours 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.
Morphine consumption (mg) Up to 48 hours The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display
Hospital morbidity Up to 48 hours 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 to hospital discharge 48 hours We define hospital stay as the elapsed time between surgery and hospital discharge
Trial Locations
- Locations (1)
San Gerardo Hospital
🇮🇹Monza, MB, Italy