Quadratus Lumborum BlockNCT06828497
Analgesic Efficacy of Quadratus Lumborum Block Against Erector Spinae Plane Block in Laparoscopic Sleeve Gastrectomy
A study testing Technique of posterior quadratus lumborum block (QL 2 block): and Technique of erector spinae plane block: in people with Quadratus Lumborum Block and Erector Spinae Plane Block, run by Port Said University hospital at 1 site in Egypt.
Trial summary
The current investigation aimed to assess the postoperative analgesic efficacy of quadratus lumborum block against erector spinae plane block in sleeve gastrectomy surgeries Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Quadratus Lumborum Block, Erector Spinae Plane Block, Sleeve Gastrectomy
- What is being tested?
- Technique of posterior quadratus lumborum block (QL 2 block): and Technique of erector spinae plane block:
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Feb 2024to 2 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (ASA) I-III,
- age > 18 years and less than 60 years
- both sexes
- scheduled for laparoscopic sleeve gastrectomy under general anaesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Quadratus Lumborum Block Against Erector Spinae Plane Block in Laparoscopic Sleeve Gastrectomy: a Prospective Randomized Study
The current investigation aimed to assess the postoperative analgesic efficacy of quadratus lumborum block against erector spinae plane block in sleeve gastrectomy surgeries
Read the 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
- Being tested
- Technique of posterior quadratus lumborum block (QL 2 block):, Technique of erector spinae plane block:
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technique of posterior quadratus lumborum block (QL 2 block):Procedure or surgery
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
Technique of erector spinae plane block:Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum Block Group | Active comparator | 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 Receives: Procedure: Technique of erector spinae plane block: |
| Erector spinae plane block Group | Active comparator | 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 Receives: Procedure: Technique of posterior quadratus lumborum block (QL 2 block): |
What is being measured
The primary outcome is the main question the study is designed to answer.
the initial request for analgesia post-surgery
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start27 Feb 2024
- Primary completion2 Feb 2025
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadratus Lumborum BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Port Said University hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Ali Hassan, Port Said University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828497
- Sponsor's protocol ID
- CT2023-014
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Quadratus Lumborum Block Against Erector Spinae Plane Block in Laparoscopic Sleeve Gastrectomy: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06828497
- Acronym / sponsor ID
- CT2023-014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Port Said University hospitalUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current investigation aimed to assess the postoperative analgesic efficacy of quadratus lumborum block against erector spinae plane block in sleeve gastrectomy surgeries
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum Block Group | Active comparator | Procedure: Technique of erector spinae plane block: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 |
| Erector spinae plane block Group | Active comparator | Procedure: Technique of posterior quadratus lumborum block (QL 2 block):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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- (ASA) I-III,
- age > 18 years and less than 60 years
- both sexes
- scheduled for laparoscopic sleeve gastrectomy under general anaesthesia
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technique of posterior quadratus lumborum block (QL 2 block):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 | Procedure or surgery | Erector spinae plane block Group |
| Technique of erector spinae plane block: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 | Procedure or surgery | Quadratus lumborum Block Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technique of posterior quadratus lumborum block (QL 2 block): and Technique of erector spinae plane block: in people with Quadratus Lumborum Block and Erector Spinae Plane Block, run by Port Said University hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the initial request for analgesia post-surgery (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.