Lidocaine Versus ESP - After Bariatric Surgery

Anesthetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700214
• Other study ID #: 1072.6120.249.2022
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In bariatric surgery, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain), visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after labdomen surgery may predict development of chronic pain. Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthetics
• Local Anesthetics

Intervention

Drug:
• Ropivacaine injection
30ml of 0.375% ropivacaine
• 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.

Locations

Country	Name	City	State
Poland	Jagiellonian University	Cracow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total long acting opioid consumption in oxycodone equivalents	the total dosage of given drug	2 days
Primary	Pain scores will be recorded at intervals.	The Numerical Rating Scale (NRS) is an 11-point scale where 0 is no pain and 10 is the worst pain imaginable.	2 days