Post-surgical pain after gastric bypass surgery in obese patients
Conditions
Interventions
Trade Name: Ropivacaína Inibsa
Pharmaceutical Form: Injection
INN or Proposed INN: ROPIVACAINE
CAS Number: 84057-95-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concen
Sponsors
Servicio de Anestesiología y Reanimación del Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients programmed for laparoscopic Roux-Y gastric bypass surgery - Age between 18 and 80 years old - Informed consent - BMI = 35 kg / m2 - That he agrees to participate in the study by signing the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Reconversion to open surgery - Allergy known to local anesthetics - Psychiatric alterations that prevent the clinical evaluation of pain - Previous history of chronic pain of any type with habitual opioid use - Severe cardiovascular disease (NYHA = III): CHF, arrhythmias, decompensated cardiomyopathies. - Treatment with class III antiarrhythmics (amiodarone, sotalol). - IRC stadium 3 or more. - Child-Pugh hepatic dysfunction class B or C. - Previous gastrointestinal surgery. - Acute porphyria - If the surgery is reconverted to open, the patient will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the postoperative pain score (using visual analogue scale, VAS) in the two groups once the patient arrives at the post-anesthetic recovery unit (immediate postoperative VAS).;Secondary Objective: - Determine if there is a difference in the VAS at 3, 6 and 24 hours. - Determine if there is a difference in morphine consumption during the first 24 hours. - Determine if there is a difference in the incidence of nausea and vomiting during the first 24 hours. - Determine if there is a difference in the presence of pain referred to the shoulder during the first 24 hours. - Determine if there are differences in the beginning of oral tolerance, ambulation and length of hospital stay. - Determine if there are cardiovascular complications in any of the groups during the first 48 hours. - Determine if there are differences in inflammatory markers at 24 hours.;Primary end point(s): To compare the postoperative pain score (using visual analogue scale, VAS) in the two groups once the patient arrives at the post-anesthetic recovery unit (immediate postoperative VAS).;Timepoint(s) of evaluation of this end point: Immediate post-operative | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Determine if there is a difference in the VAS at 3, 6 and 24 hours. - Determine if there is a difference in morphine consumption during the first 24 hours. - Determine if there is a difference in the incidence of nausea and vomiting during the first 24 hours. - Determine if there is a difference in the presence of pain referred to the shoulder during the first 24 hours. - Determine if there are differences in the beginning of oral tolerance, ambulation and length of hospital stay. - Determine if there are cardiovascular complications in any of the groups during the first 48 hours. - Determine if there are differences in inflammatory markers at 24 hours.;Timepoint(s) of evaluation of this end point: At 3,6, 24 and 48 hours post-surgical. | — |
Countries
Spain
Contacts
Public ContactHOI TONG
UCICEC
Outcome results
None listed