Quadratus Lumborum Block vs Erector Spinal Block for Post Abdomen Surgery Analgesia

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05446727
• Other study ID #: 1072.6120.32.2022
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Jagiellonian University
• Contact: Tomasz Skladzien, phd md
• Phone: 506602250
• Email: t.skladzien[@]interia.pl
• 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. 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.

Description:

In abdomen 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: 1000
• Est. completion date: December 31, 2023
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anesthetics, Local
• Pain, Acute
• Postoperative Pain

Intervention

Drug:
• Ropivacaine injection
30ml of 0.375% ropivacaine

Locations

Country	Name	City	State
Poland	Jagiellonian University	Cracovia	Maloposkie

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
Secondary	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.	The patients will be asked about level of pain every 2 hours	2 days
Secondary	Incidence of postoperative nausea-vomiting; respiratory depression; itching; local anesthetic toxicity; catheter leakage and catheter migration; infection at catheter site	The patients will be asked about Incidence of postoperative nausea-vomiting; respiratory depression; itching; local anesthetic toxicity; catheter leakage and catheter migration; infection at catheter site.	7 days