- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06828497
Analgesic Efficacy of Quadratus Lumborum Block Against Erector Spinae Plane Block in Laparoscopic Sleeve Gastrectomy
Analgesic Efficacy of Quadratus Lumborum Block Against Erector Spinae Plane Block in Laparoscopic Sleeve Gastrectomy: a Prospective Randomized Study
Study Overview
Status
Detailed Description
In bariatric surgeries, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain) due to trocar insertion sites, visceral pain (deep intra-abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.
The ultrasound-guided erector spinae plane (ESP) block influences both visceral and somatic pain; therefore, its use in laparoscopic surgeries and other abdominal surgeries can be advantageous. . ESP block is reported to lead to an analgesic effect on somatic and visceral pain by affecting the ventral rami and rami communicantes that include sympathetic nerve fibers, as local anesthetic spreads through the paravertebral space. When performed bilaterally, it can be as effective as thoracic epidural analgesia. Thoracic surgery and T seven level for abdominal surgeries. The number of surgeries involving multiple procedures and/or incisions is increasing, with such surgeries requiring complex analgesia protocols for pain management.
Currently, the Quadratus Lumborum (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, producing somatic and visceral analgesia; the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Mansoura, Egypt, 42526
- Egyptian liver hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- (ASA) I-III,
- age > 18 years and less than 60 years
- both sexes
- scheduled for laparoscopic sleeve gastrectomy under general anaesthesia
Exclusion Criteria:
- patient refusal,
- bleeding or coagulation abnormality
- local skin infection and sepsis at site of the block,
- hypersensitivity to the study drugs,
- body mass index > 50 kg/m²,
- Drug abuse, diabetes mellitus (DM), neurological or neuromuscular diseases, cardiovascular illnesses
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Quadratus lumborum Block Group
The patient was in the lateral position, and the US probe was placed in the anterior axillary line to visualize the typical triple abdominal layers.
Then, the probe was placed in the midaxillary line, and at this juncture, the layers of abdominal layers started to taper.
When the probe was placed in the posterior axillary line as per the posterior approach, sonoanatomy showed first the transversus abdominis disappearing, then the internal oblique and external oblique forming aponeurosis, and the appearance of the QL muscle was noticed.
The posterior aspect of the QL muscle was confirmed, and a 22-G block needle was guided, in plane, and the needle tip was inserted into this aspect of the QL muscle.
Following aspiration, the local anesthetic was injected into the lift behind the QL muscle.
The same procedure was performed bilaterally
|
The patient will be placed in a sitting position.
Under aseptic conditions, a high-frequency linear transducer will be placed on the spinous process at the T8 level on the parasagittal plane and then slide 2.5-3 cm laterally to visualize the transverse process and erector spinae muscle.
Using the in-plane technique, the needle was advanced between the transverse process and erector spinae muscle.
The correct location was confirmed, and local anesthetic was injected between the muscle and transverse process.
The same procedure was performed bilaterally
|
|
Active Comparator: Erector spinae plane block Group
The patient will be placed in a sitting position.
Under aseptic conditions, a high-frequency linear transducer will be placed on the spinous process at the T8 level on the parasagittal plane and then slide 2.5-3 cm laterally to visualize the transverse process and erector spinae muscle.
Using the in-plane technique, the needle was advanced between the transverse process and erector spinae muscle.
The correct location was confirmed, and local anesthetic was injected between the muscle and transverse process.
The same procedure was performed bilaterally
|
The patient was in the lateral position, and the US probe was placed in the anterior axillary line to visualize the typical triple abdominal layers.
Then, the probe was placed in the midaxillary line, and at this juncture, the layers of abdominal layers started to taper.
When the probe was placed in the posterior axillary line as per the posterior approach, sonoanatomy showed first the transversus abdominis disappearing, then the internal oblique and external oblique forming aponeurosis, and the appearance of the QL muscle was noticed.
The posterior aspect of the QL muscle was confirmed, and a 22-G block needle was guided, in plane, and the needle tip was inserted into this aspect of the QL muscle.
Following aspiration, the local anesthetic was injected into the lift behind the QL muscle.
The same procedure was performed bilaterally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the initial request for analgesia post-surgery
Time Frame: 24 hours
|
analgesia request willbe assessed by Pain intensity was measured using the Visual Analogue Scale (VAS) score, the scale from 0 to 10 and 10 is the worst pain
|
24 hours
|
Collaborators and Investigators
Sponsor
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CT2023-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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.
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