Elective cholecystectomy
Conditions
Interventions
Trade Name: Levobupivacaína Altan 5 mg/ml solución inyectable y para perfusión EFG
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: LEVOBUPIVACAINE
CAS Number: 27262-47-1
Conc
Sponsors
Pablo Rama Maceiras
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 85 years. (2) Laparoscopic elective cholecystectomy intervention with planned hospital admission. (3) ?ASA Physical Status Classification System =65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: (1) Patient refusal (2) known hypersensitivity to any of the medications used in this study (3) opiates chronic use (4) epilepsy (5) psychomotor delay (6) morbid obesity (defined as BMI> 40) (7) obstructive sleep apnea syndrome (8) presence of a heart rhythm block that requires a pacemaker implant (9) liver failure (defined as total preoperative serum bilirubin > 2 mg / dl) (10) renal insufficiency (defined as estimated renal glomerular filtration rate = 50 ml / min / 1.73 m2) (11) pregnancy (12) local skin infection at the puncture site level
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare two commonly used analgesic techniques in anesthesia for laparoscopic cholecystectomy and to assess if there are some differences between them as to the need of use additional analgesic (morphic chloride) in the immediate postoperative period (first 4 postoperative hours);Secondary Objective: (1) To assess postoperative pain intensity, according to Visual Analog Scale (VAS) at rest and with mobilization or cough. Where 0= no pain and 10= the worst imaginable pain, depending on the block method made in the operating room. (2) To evaluate the time from patient's recovery admission to the first analgesia request. (3) To determine incidence and intensity of postoperative nausea or vomit, as well as antiemetic intake and if there are some differences depending on the block method made. (4) To record complications during surgery and postoperatively such as conversion to open surgery (it will imply patient withdrawal), bleeding, infection, or need of reintervention.;Primary end point(s): - Total morphine dose (mg), required by patients in the period studied. - Number of patients who required morphic chloride administration in the period studied.;Timepoint(s) of evaluation of this end point: The evaluation of the study endpoints will be carried out in the first four hours of the postoperative period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Postoperative pain intensity, according to Visual Analog Scale (VAS) at rest and with mobilization or cough. Where 0= no pain and 10= the worst imaginable pain. - Time from patient's recovery admission to the first analgesia request. - Incidence and intensity of postoperative nausea or vomit, as well as antiemetic intake (Ondansetron). - Total dose of remifentanil used intraoperatively. - The duration of operation in minutes. - The duration of the stay in the postoperative Recovery room (in hours) and in the hospital (in days). - Complications during surgery and postoperatively such as conversion to open surgery (it will imply patient withdrawal), bleeding, infection, or need of reintervention (it will imply patient withdrawal, as well).;Timepoint(s) of evaluation of this end point: - The VAS will be evaluated at admission; every 30 minutes during the first two postoperative hours and every hour during the staying in the recovery unit. - The other variables of the study will be carried out in the first four hours of the postoperative period. | — |
Countries
Spain
Contacts
Public ContactServicio de Anestesiología y Rea.
Pablo Rama Maceiras
Outcome results
None listed