- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05446727
Quadratus Lumborum Block vs Erector Spinal Block for Post Abdomen Surgery Analgesia
Quadratus Lumborum Block Versus Erector Spinal Block - Comparison of the Effectiveness of the Analgesic Effect in Patients After Abdominal Surgery
Prior to surgery, patients will be stratified into groups according to the type of surgical procedure. The anticipated groups are as follows:
Patients with colorectal cancer
Patients with prostate cancer
Patients with renal cancer
Patients undergoing surgery for gallbladder cholelithiasis. 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 anterior QL block ( QL1 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maloposkie
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Krakow, Maloposkie, Poland, 31-501
- Jagiellonian University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Quadratus Lumborum block group
Experimental: Quadratus Lumborum block group Patients were placed in the lateral decubitus position.
After skin disinfection, a linear high-frequency ultrasound probe guarded with a sterile cover was set above the iliac crest and shifted cranially until the three abdominal wall muscles were distinguished.
Then, it was moved medially until latissimus dorsi and quadratus lumborum (QLM) muscles were shown within identical short-axis views.
A 21-gauge needle was inserted from the edge of the probe using an in-plane technique and advanced into the fascia over the QLM.
After ensuring negative aspiration for blood, 30 ml of 0.35% ropivacaine bilateral was injected slowly into the fascial interspace.
|
30ml of 0.35% ropivacaine bilaterally
|
|
Experimental: erector spinae planae block
The ESP block was performed with the patient in a sitting position.
After skin disinfection, a linear high-frequency (L14-6NS) ultrasound probe, covered with a sterile sheath, was positioned sagittally 1-2 cm lateral to the midline at the level of the ninth thoracic vertebra (T9).
The T9 level was earlier identified by palpating the spinous process of the seventh cervical vertebra and counting down nine intervertebral spaces.
After identifying the erector spinae muscle (ESM) and transverse process, a 21-gauge needle was inserted deep into the ESM in a cranio-caudal direction, using an in-plane technique.
The needle was advanced, ensuring that it crossed all muscle layers until it contacted the transverse process.
A total of 60 mL of 0.35% ropivacaine was given.
This procedure was performed bilaterally on each patient.
|
30ml of 0.35% ropivacaine bilaterally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total long acting opioid consumption in oxycodone equivalents
Time Frame: 1 days
|
the total dosage of given drug
|
1 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: 1 days
|
The patients will be asked about level of pain every 2 hours
|
1 days
|
|
Incidence of postoperative nausea-vomiting; itching; local anesthetic toxicity;
Time Frame: 1vdays
|
The patients will be asked about Incidence of postoperative nausea-vomiting; itching; local anesthetic toxicity.
|
1vdays
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1072.6120.32.2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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