Laparoscopic Cholecystectomy, Levobupivacaine, Local Infiltration, Postoperative Pain
Conditions
Keywords
Laparoscopic cholecystectomy, Postoperative Pain, Local Infiltration, Levobupivacaine, Randomized controlled trial
Brief summary
Randomized controlled trial on laparoscopic cholecystectomy. Interventional group: preincisional infiltration with levobupivacaine. Control group: no local infiltration. Postoperative pain with numeric rating scale is registered, besides other parameters like heart rate, blood pressure, rescue analgesia requirements, nausea and vomiting, etc.
Interventions
DRUGPreincisional infiltration with levobupivacaine
Local, preincisional infiltration of port sites with levobupivacaine 5 mg/ml 20 ml
Sponsors
Hospital Universitario de Móstoles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective laparoscopic cholecystectomy
Exclusion criteria
* Patient refusal * Open surgery * Reintervention surgery * Drain tube placement * Cognitive impairment * Allergic reactions to local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain assessed by visual numeric scale. | 24 hours | Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain. Best outcome would be 0 or close to 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative administration of analgesics | 24 hours | Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements |
| Postoperative nausea and vomiting episodes | 24 hours | Record of episodes of nausea or vomiting during first 24 postoperative hours |
Countries
Spain
Outcome results
None listed