Postoperative pain
Conditions
Interventions
Trade Name: Bupivacaina hidrocloruro 5 mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE
Other descriptiv
Sponsors
Rafael Uña
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age between 18 and 75 years - Hepatic or pancreatic pathology that is going to be operated through open scheduled surgery at the La Paz university hospital (hepatic resection or pancreatic resection with Whipple type reconstruction). - Sign 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Patients allergic to local anesthetics. ? Patients classified as ASA IV. ? Patients diagnosed with mental retardation (communicative disability with the researcher). ? Technical impossibility to carry out spinal anesthesia (scoliosis, postsurgical manipulation of the lumbar spine and / or lipoma). ? Patients previously operated on for open surgery by midline laparotomy. ? Personal history of chronic use (more than 1 month) of opioids. ? Patients with chronic renal failure (estimated glomerular filtration rate less than 60 ml / min / 1.73 m2 and / or creatinine greater than 1.5 mg / dl. ? Patients diagnosed with epilepsy (treated with antiepileptic drugs for more than 1 year). ? Patients with hepatic impairment (Child B Classification and / or C in the last month). ? Patients with morbid obesity (BMI greater than 39). ? Patients diagnosed with obstructive sleep apnea syndrome who are being treated with nocturnal CPAP. ? Patients who according to the investigator's criteria will not be able to perform the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish which of the two strategies for treatment of postoperative pain (regional neuraxial anesthesia with morphic chloride and incisional catheters type On-Q) is more effective and safe in patients electively submitted to open surgery of hepatic or pancreatic pathology. To compare the analgesic efficacy defined as EVA at 24 hours after surgery less than or equal to 3 points out of 10 ; Secondary Objective: - Establish intravenous morphic chloride consumption during the first three postoperative days in both groups. - Collect the EVA score with cough and at rest at the exit of the operating room, at 12 hours after the end of surgery, at 24 hours, at 48 hours and at 72 hours. - Incidence of side effects and complications (isolated nausea, respiratory depression, pruritus, isolated vomiting, dizziness, paralytic ileus) in both groups. - Duration of hospital stay in days. ;Primary end point(s): The primary objective of the study will be the EVA 24 hours after the end of surgery. It will be considered effective when the patient has an EVA score less than or equal to 3/10 at 24 hours.;Timepoint(s) of evaluation of this end point: 24 hours post operation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The milligrams of intravenous morphine chloride administered during the first three postoperative days will be evaluated. - Pain at rest and with cough up to five times using the EVA scale: at the exit of the operating room (at 0 o'clock), at 12 o'clock, at 24 o'clock, at 48 o'clock and at 72 o'clock at the end of the intervention. - The safety of analgesic strategies monitoring the appearance of adverse effects such as hypotension, respiratory depression, nausea, vomiting and paralytic ileus (hours from the onset of tolerance to the emission of gases and / or feces). - Duration of hospital stay in days. ;Timepoint(s) of evaluation of this end point: At zero hours, at 12 hours and 72 hours after the operation. | — |
Countries
Spain
Contacts
Public ContactLaura Fernández Benítez
Laura Fernández Benítez
Outcome results
None listed