Pain in lumbosacral surgery
Conditions
Interventions
Trade Name: Ropivacaína Inibsa 2 mg/ml solución inyectable EFG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ROPIVACAINE
CAS Number: 84057-95-4
Concentration unit: mg/ml milligram(s
Sponsors
Fundación Pública Andaluza Progreso y Salud
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Ages between 18 and 75 years. - ASA I, II, III patients. - Patients with a body mass index (BMI) of less than 35 kg/m2. - Patients programmed by both the traumatology and neurosurgery departments of the Hospital Juan Ramón Jiménez for lumbosacral surgery. - Informed consent signed by the patient or legal representative to participate in the study. 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 91 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: - Patients with psychiatric illness, substance abuse, drug or alcohol dependence, history of chronic pain. - Patients with cardiac arrhythmias or pacemakers. - Patients with altered coagulation parameters, - History of allergy or intolerance to local anaesthetics, morphine or derivatives. - Infection in the region of intervention. - Surgery for vertebral fractures at lumbar level, surgery for oncological causes and/or previous surgery at lumbar level. - Surgeries involving more than 2 lumbar spaces.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the analgesic efficacy of ultrasound-guided erector spinae plane blockade (ESPB) at lumbar level with ropivacaine 0.2 % (2 mg/ml) in the control of postoperative pain during 24 hours in patients undergoing lumbosacral surgery compared to ESPB performed with ropivacaine 0.3 % (3 mg/ml) and ESPB performed with Physiological Serum 0.9 %.;Secondary Objective: - To evaluate: • The intraoperative analgesic efficacy of ESPB • The use of ESPB to reduce the total intraoperative remifentanil dose. • The use of ESPB in the reduction of perioperative complications derived from the use of opioids. • The safety of the technique in the form of perioperative adverse events. • The usefulness of ESPB in early mobilisation without postoperative pain in patients who underwent lumbosacral spine • The sensory level achieved by performing the block at the L3 level. • A possible association between ESPB with the appearance of motor or sensory alterations at the lower limb level. - To determine: • The concentration of ropivacaine (0.2 % vs. 0.3 %) at which analgesic efficacy is achieved during the first 24h. • The level of patient satisfaction with the anaesthetic technique.;Primary end point(s): 1.- Determination of the patient's pain at rest using the Visual Analogue Scale (VAS). 2.- Recording of supplementary analgesia administered by the patient himself through the controlled analgesia pumps, obtaining the total number of boluses of morphine administered.;Timepoint(s) of evaluation of this end point: 1.- Before undergoing surgery, 2 hours after arrival at the Postanaesthesia Recovery Unit and 24 hours post-operatively. (+/- 3 h). 2.- During the 24-hour follow-up period after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.- Intraoperative nociception monitoring through the NOL (nociception level) monitor. 2.- Total remifentanil dose measured through the data recorded in the remifentanil continuous perfusion pump. 3.- Concentration of ropivacaine that achieves best analgesic efficacy. 4.- Complications associated with the use of perioperative opioids. Presence of perioperative complications, to evaluate the safety of the technique. 6.- Determination of the patient's pain in movement using the Visual Analogue Scale (VAS). 7.- Association of ESPB with motor and/or sensory alterations and as a complementary measure of the safety of the technique. 8.- Test of hot-cold sensitivity by contact with the patient's skin with a cotton swab soaked in alcohol. 9.- Patient Global Impression of Change Scale (PGIC).;Timepoint(s) of evaluation of this end point: 1.- Its value will be obtained during the intraoperative period in a non-invasive and continuous manner. 2.- In the intraoperative period. 3.- From the time the patient undergoes the erector spinae block until the first dose of analgesic rescue is required. 4.- Perioperative period. 5.- Perioperative period. 6.- Before undergoing surgery, 2 hours after arrival at the Post-anaesthesia Recovery Unit and 24 hours post-operatively. (+/- 3 h). 7.- Before undergoing surgery, 2 hours after arrival at the PACU and 24 hours after surgery (+/- 3 hours). 8.- 2 hours after arrival at the PACU and 24 hours after surgery (+/- 3 hours). 9.- Last follow-up visit. | — |
Countries
Spain
Contacts
Public ContactPaula Callejo García
Fundación Pública Andaluza Progreso y Salud
Outcome results
None listed