Cholecystolithiasis, Postoperative Pain
Conditions
Keywords
gallstone, gallbladder, cholecystectomy, laparoscopic, pain
Brief summary
To determine the effect of combined intracutaneous infiltration and intraperitoneal instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic cholecystectomy on abdominal pain up to 24 hours after surgery.
Detailed description
The primary endpoint of this study was postoperative abdominal pain as measured by a visual analogue scale (VAS), using a VAS lineal with a slide. The patient was asked to indicate a score from 0 to 100 corresponding to his or her pain. At 0.5, 2, 4, 8 and 24 hours after the surgical procedure the primary investigator visited the patient to obtain the VAS scores.
Interventions
DRUGLevobupivacaine
0.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally
Sponsors
Meander Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* between 18 and 80 * ASA I or II * with symptomatic gallstone disease which requires elective laparoscopic cholecystectomy
Exclusion criteria
* acute cholecystitis, cholangitis, severe acute pancreatitis, advanced liver cirrhosis or suspected gallbladder cancer, * a medical history of epilepsy, cardiac arrhythmias or chronic pain of any kind, - allergy to amid type drugs * pregnancy * patients suffering from hypotension or hypovolemia * infectious liver disease * conditions obstructing adequate pain scoring * patients using drugs that deduce function of the CYP3A4 or CYP1A2 system * patients having an American Society of Anaesthesiologists (ASA) classification of three or higher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal Pain in Visual Analogue Scale (VAS 0-100mm) | 24 h postoperatively | Postoperative abdominal pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue Analgesics | 24 h postoperatively | The need of rescue analgesics within the 24h postoperatively |
| adverse events caused by the investigational procedure or by levobupivacaine itself | Intra- and postoperative up to 24 hours | Adverse events were defined as neurological or cardial effects attributable to use of levobupivacaine. Adverse events by the procedure such as bleeding were also registered. |
| Shoulder pain | 24 h | Postoperative shoulder pain |
| intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures | intraoperative, 1 hour | — |
| postoperative complications during hospitalisation | during hospitalisation (up to two weeks) | Infection, bleeding, embolisation etc. |
| Length of hospital stay | Maximum two weeks | — |
Countries
Netherlands
Outcome results
None listed