Clinical trial

Continuous Infusion of Lidocaine Versus Blockade of the Erector Spinae Plane Block - Comparison of Analgesic Efficacy in Patients After Bariatric Surgery

Name
1072.6120.249.2022
Description
The Erector Spinal Block (ESP) is based on the deposition of the local anesthetic in the inter-fascial space between the dorsal extensor muscle and the intercostal muscles at the height of the transverse processes. The scope of the blockade covers the dorsal and ventral branches of the thoracic spinal nerves, but also in most cases the investigetors are able to obtain a wide distribution of the drug into the paravertebral space by "permeating" the local anesthetic through the fascial compartments. The clinical effect of the blockade is due to blocking the nerve structures of the paravertebral space (spinal nerve branches and the sympathetic trunk). The scope of the blockade, after its execution at the level of Th5, most often includes the segments from Th1 to L1. Lidocaine used in intravenous infusion is one of the recommended components of multidirectional analgesia. Its adjuvant properties make it possible to reduce the amount of opioid drugs used, and thus - to reduce the frequency of their side effects. The aim of the study is to test the effectiveness and safety of the use of lidocaine infusion or Erector Spinal Block in multimodal analgesic management.
Trial arms
Trial start
2023-01-16
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Treatment
Ropivacaine injection
30ml of 0.375% ropivacaine
Arms:
ESP block
Other names:
ESP block
Lidocaine IV
Before induction bolus of 1% lidocaine 1,5mg/kg IBW i.v., continuous infusion of 1% lidocaine intraoperatively rate 1 mg/kg IBW i.v.
Arms:
lidocaine
Size
100
Primary endpoint
Total long acting opioid consumption in oxycodone equivalents
2 days
Pain scores will be recorded at intervals.
2 days
Eligibility criteria
Inclusion Criteria: Patients requiring bariatric surgery Obesity (BMI\>35) Exclusion Criteria: Patient refusal Contraindications to paravertebral blocks: Infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation Known allergy to local anesthetics Inability to provide informed consent Any patient on opioids for greater than or equal to 3 months duration prior to surgery Patients with chronic pain syndromes
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-06-07

1 organization

2 products

2 indications

Indication
Anesthetics
Product
Lidocaine