Clinical trial

Quadratus Lumborum Block Versus Erector Spinal Block - Comparison of the Effectiveness of the Analgesic Effect in Patients After Abdominal Surgery

Name
1072.6120.32.2022
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. Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic prostatectomy has not been investigated before and it is the variant that will be discussed in our study.
Trial arms
Trial start
2022-05-01
Estimated PCD
2022-05-06
Trial end
2023-12-31
Status
Recruiting
Treatment
Ropivacaine injection
30ml of 0.375% ropivacaine
Arms:
ESP, QLB
Size
1000
Primary endpoint
Total long acting opioid consumption in oxycodone equivalents
2 days
Eligibility criteria
Inclusion Criteria: * Patients requiring abdomen surgery * Patients of age 18 and over * BMI \< 40 * Patients who are expected to stay in-hospital overnight after surgery 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 * Inability to use a PCA due to languate or comprehension barriers * BMI \>= 40 * 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': 1000, 'type': 'ESTIMATED'}}
Updated at
2023-06-06

1 organization

1 product

5 indications

Indication
Pain
Indication
Acute
Indication
Anesthetics
Indication
Local