Double Blind Randomized Phase III Controlled Trial Comparing the Effect of Preoperative and Postoperative Nebulization of Ropivacaine on Pain Control After Laparoscopic Cholecystectomy
Overview
- Phase
- Phase 3
- Intervention
- Ropivacaine 30 mg
- Conditions
- Laparoscopic Cholecystectomy
- Sponsor
- San Gerardo Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Postoperative Pain
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Preoperative Nebulization
Nebulization of 30 mg of Ropivacaine in the peritoneal cavity before surgery
Intervention: Ropivacaine 30 mg
Postoperative Nebulization
Nebulization of 30 mg of Ropivacaine in the peritoneal cavity after surgery
Intervention: Ropivacaine 30 mg
Control
Nebulization of normal saline 3 ml before and after surgery
Intervention: Saline
Outcomes
Primary Outcomes
Postoperative Pain
Time Frame: 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 Outcomes
- Time of unassisted walking(Up to 48 hours)
- Morphine consumption (mg)(Up to 48 hours)
- Hospital morbidity(Up to 48 hours)
- Time to hospital discharge(48 hours)