Evaluate pain after surgery with spinal anesthesia with morphine chloride. incisional catheters

Phase 1

• Conditions: Postoperative pain; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-001502-23-ES
• Lead Sponsor: Rafael Uña

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-04
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 60

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

? 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified