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Comparison of the Erector Spinae plane block in pulmonary surgeries in relation to Paravertebral block

Comparison of analgesia of Erector Spinae plane block in pulmonary surgeries in relation to Paravertebral block: a randomized multicenter study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9qrsf8
Enrollment
Unknown
Registered
2020-08-12
Start date
2020-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic pain, unspecified

Interventions

A total of 240 patients will be allocated into two intervention groups: Group A and Group B. Group A will receive an Erector spinae plane block at the level of the transverse process of T5 guided by
Procedure/surgery

Sponsors

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo - HCFMRP
Lead Sponsor
IAMSPE - Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age undergoing unilateral pulmonary surgery under thoracotomy or thoracoscopy approach.

Exclusion criteria

Exclusion criteria: Patients who refuse participation. Severe puncture site infection or deformity. Coagulation disorder (INR greater than 1.4 or use of anticoagulant medications and platelet count less than 100,000 / mm3). Body mass index greater than 35kg / m2. Renal impairment (creatinine clearance less than 30 ml/min). Failure to operate the PCA system or to sign the informed consent form. Patients undergoing bilateral surgery.

Design outcomes

Primary

MeasureTime frame
Evaluate the pharmacokinetics of the local anesthetic in the first 24 postoperative hours, using standardized tests. The serum concentration of local anesthetic will be assessed by collecting blood tests in two stages: the first stage, immediately after infusion of 0.4 mL?Kg of 0.5% ropivacaine in BPES or BPVT with the objective of determining Cmax parameters (maximum plasma concentration) and Tmax (time required to reach Cmax), at collection times: 1; 2.5; 5; 7.5; 10; 12.5; 15; 17.5; 20; 25; 30 minutes after the infusion of ropivacaine and in the second step to assess the continuous infiltration of 0.1 mL?Kg?h of 0.2% ropivacaine through a catheter in order to determine the CSS parameter (steady state plasma concentration) through blood test collected 24 h after the beginning of continuous ropivacaine infiltration.;To evaluate the efficacy of the pain control therapies under study in the first 24 hours postoperatively, through standardized scales that will be applied to patients in 3 moments: on admission to the anesthetic recovery room, at the time of discharge from the anesthetic recovery room and on the first postoperative day, 24 hours after the end of the surgical procedure. In order to guarantee efficacy of the measurement of pain, 3 different scales will be used simultaneously: the numerical scale, that quantifies the pain in a score of 0 to 10 of intensity, the qualitative scale, that quantifies the pain according to verbal descriptors like "no pain" , "Mild pain", "moderate pain", "intense / strong pain" or "unbearable pain", and the pain faces scale, a tool that represents the dimension of pain with images of pain face expressions.

Secondary

MeasureTime frame
To evaluate the degree of satisfaction of the patient with analgesia, quantified through a score of 0 to 10, in the first 24 hours postoperatively.;Evaluate the demand for supplementary opioid, quantified through the patient's controlled analgesia system of venous morphine, in the first 24 hours postoperatively.;Evaluate the incidence of complications associated with the technique of regional anesthesia, by recording all the procedures performed. ;Evaluate the degree of difficulty in performing the regional anesthesia technique, quantified by a score of 0 to 10 determined by the physician who performed the block.;Evaluate the length of hospital stay through the hospital records of the patients included in the study.;Evaluate demand for ventilatory support through the consultation of medical records.

Countries

Brazil

Contacts

Public ContactPedro Hilton Andrade Filho

Faculdade de Medicina da Universidade de São Paulo

pedrohafilho@usp.br+55-011-30617000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)