Quadratus Lumborum BlockNCT04402411
Quadratus Lumborum Block vs Transversus Abdominis Plane Block in Bladder Cancer Surgeries
A study testing Quadratus lumborum block, Transversus abdominis plane block and Intravenous opioid in people with Quadratus Lumborum Block and Transversus Abdominis Plane Block, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Transversus abdominis plane (TAP) block can be used to provide effective analgesia during the postoperative period following a range of surgeries. TAP block administers local anesthetics between the T6 to L1 spinal nerve roots to stop the nerve signal and to alleviate pain for abdominal procedures 4, 5. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Quadratus Lumborum Block, Transversus Abdominis Plane Block, Bladder Cancer
- What is being tested?
- Quadratus lumborum block, Transversus abdominis plane block and Intravenous opioid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 5 Oct 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of the patients between 20 to 80 years.
- ASA physical status II -III
- Elective bladder cancer operations.
Who cannot join
- Patient refusal
- Local infection at the site of injection
- Allergy to study medications
- Sepsis
- Anatomic abnormalities
- Systemic anticoagulation or coagulopathy
- Inability to comprehend or participate in pain scoring system
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute - Egypt
Cairo, 11796
Atef Badran, PhD, 0020101200155, atef.badran@nci.cu.edu.eg
About this study
Official title: Comparison Between Quadratus Lumborum Block and Transversus Abdominis Plane Block in Bladder Cancer Surgeries
Transversus abdominis plane (TAP) block can be used to provide effective analgesia during the postoperative period following a range of surgeries.
TAP block administers local anesthetics between the T6 to L1 spinal nerve roots to stop the nerve signal and to alleviate pain for abdominal procedures 4, 5.
Read more
The viscera are innervated by the vagal nerve (parasympathetic innervation) and by the splanchnic nerves (sympathetic innervation). The splanchnic nerves carry both visceral efferent and afferent nerve fibers. The sensory (or afferent) part of the splanchnic nerves reach the spinal column at certain spinal segments, It is possible to block central visceral pain conduction with thoracic paravertebral blockade or maybe even with the novel quadratus lumborum (QL) block.
The effect of the QL block is believed to result from a spread of LA from its lumbar deposition cranially into the thoracic paravertebral space (TPVS), since Carney et al found traces of contrast agent in the TPVS following application of this block. Hence, the QL block would seem to be able to alleviate both somatic and visceral pain.10
The aim of this study is to compare between quadratus lumborum block, transversus abdominis plane block regarding perioperative analgesia after bladder cancer surgeries by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative.
Read the detailed description
Somatic post-surgical pain is very distressing to patients which leads to important complications. Combined multimodal strategies involving nerve blocks, neuroaxial blocks, opiates, and non-steroidal anti-inflammatory drugs are necessary for optimal pain control.
Transversus abdominis plane (TAP) block can be used to provide effective analgesia during the postoperative period following a range of surgeries.
TAP block administers local anesthetics between the T6 to L1 spinal nerve roots to stop the nerve signal and to alleviate pain for abdominal procedures.
A number of systematic reviews have assessed TAP block as a postoperative analgesic compared to one or more specific procedures.
Anterior abdominal wall blocks, as transverse abdominal plexus block, have an important role for only somatic intraoperative and postoperative pain control.
The viscera are innervated by the vagal nerve (parasympathetic innervation) and by the splanchnic nerves (sympathetic innervation). The splanchnic nerves carry both visceral efferent and afferent nerve fibers. The sensory (or afferent) part of the splanchnic nerves reach the spinal column at certain spinal segments, It is possible to block central visceral pain conduction with thoracic paravertebral blockade or maybe even with the novel quadratus lumborum (QL) block.
The effect of the QL block is believed to result from a spread of LA from its lumbar deposition cranially into the thoracic paravertebral space (TPVS), since Carney et al found traces of contrast agent in the TPVS following application of this block. Hence, the QL block would seem to be able to alleviate both somatic and visceral pain.10 Quadratus lumborum block was first described by Blanco in 2007. Blanco described a potential space posterior to the abdominal wall muscles and lateral to the quadratus lumborum muscle. It has been used in abdominoplasties, caesarean sections and lower abdominal operations providing complete pain relief in the distribution area from Th6 to L1 dermatomes. It may be seen as a lumbar approach to the Thoracic Paravertebral Space. The block apparently produces distribution of the local anesthetic extending proximally and over both sides of the surface of the QL muscle, in between the anterior and intermediate layers of the thoracolumbar fascia.
Quadratus lumborum muscle inserts on the lower border of the last rib and by four small tendons into the apices of the transverse processes of the upper four lumbar vertebrae.
Running between its fascia and the muscle are the twelfth thoracic (subcostal), ilioinguinal, and iliohypogastric nerves, The block does not rely on the feeling of any pops or fascial clicks because depending of the angle of the needle several pops can be felt without reaching the target zone, which is lateral to the quadratus lumborum muscle. Actually, the block has never been intended to be conducted without the use of US guidance, and the block is thus a purely USG block.
Aim of study Comparison between quadratus lumborum block, transversus abdominis plane block regarding perioperative analgesia after bladder cancer surgeries by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative.
- Conditions
- Quadratus Lumborum Block, Transversus Abdominis Plane Block, Bladder Cancer, Postoperative Pain, Surgery
- Being tested
- Quadratus lumborum block, Transversus abdominis plane block, Intravenous opioid
- Medical subject headings
- Urinary Bladder Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum blockProcedure or surgery
Also called Group B
The patient will be placed in a lateral position with the side to be blocked facing upwards. The ultrasound probe will be properly sterilized and with sterile covers. An 18-20 gauge blunt tipped block needle or a Tuohy needle is advanced under ultrasound guidance on the posterior aspect of the Quadratus Lumborum. The QL muscle is identified with its attachment to the lateral edge of the transverse process of the L4 vertebral body. With the psoas major muscle anteriorly, the erector spinae muscle posteriorly and the QL muscle adherent to the apex of the transverse process, a well recognisable pattern of a shamrock with three leaves can be seen.
Transversus abdominis plane blockProcedure or surgery
Also called Group C
The patient will be supine while performing the block and sterilization of the site of the ultrasound and needle entry will be performed.
The ultrasound probe is placed in a transverse plane to the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest.
The needle is introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles.
Intravenous opioidDrug
Also called Group A
Patients will receive morphine 0.1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients will receive general anesthesia with intravenous opioid Receives: Drug: Intravenous opioid |
| Quadratus lumborum | Experimental | Patients will receive bilateral quadratus lumborum block Receives: Procedure: Quadratus lumborum block |
| Transversus abdominis plane | Experimental | Patients will receive bilateral transversus abdominis plane block Receives: Procedure: Transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue dose of morphine
First time at which morphine was given postoperatively (If Vsual analogue scale (VAS) was >4, 3 mg morphine IV was administered as a rescue analgesia for the first 24 hours)
Measured: 24 hours
Secondary outcomes (2)
Total dose of postoperative morphine consumption
Postoperative analgesia was provided by 1 gm paracetamol IV every 8 hours as a routine analgesia and if VAS was >4, 3 mg morphine IV was administered as a rescue analgesia for the first 24 hours.
Measured: 24 hours
Pain intensity by visual analogue scale (VAS)
Visual analogue scale (VAS) was recorded at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24 hours postoperative.
(0: No pain, 1-3: Mild pain, 4-6: Moderate pain, 7-9: Severe pain and 10: The worst imaginable pain) Minimum:0 and Maximum 10 The higher, the worst
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 posted26 May 2020
- Study start1 Jun 2020
- Primary completion30 Sep 2020
- Study completion5 Oct 2020 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Mohammed, MSc, Principal investigator, Assistant lecturer of Anesthesia, ICU, and Pain Relief
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402411
- Sponsor's protocol ID
- 201617049.3
- Status last verified
- Oct 2020
- First submitted
- 18 Apr 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I don't want to share
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Quadratus Lumborum Block and Transversus Abdominis Plane Block in Bladder Cancer Surgeries
- ClinicalTrials.gov ID
- NCT04402411
- Acronym / sponsor ID
- 201617049.3
- Conditions
- Quadratus Lumborum Block, Transversus Abdominis Plane Block, Bladder Cancer, Postoperative Pain, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 5 Oct 2020 (estimated)
- First posted
- 26 May 2020 (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.
Transversus abdominis plane (TAP) block can be used to provide effective analgesia during the postoperative period following a range of surgeries.
TAP block administers local anesthetics between the T6 to L1 spinal nerve roots to stop the nerve signal and to alleviate pain for abdominal procedures 4, 5.
The viscera are innervated by the vagal nerve (parasympathetic innervation) and by the splanchnic nerves (sympathetic innervation). The splanchnic nerves carry both visceral efferent and afferent nerve fibers. The sensory (or afferent) part of the splanchnic nerves reach the spinal column at certain spinal segments, It is possible to block central visceral pain conduction with thoracic paravertebral blockade or maybe even with the novel quadratus lumborum (QL) block.
The effect of the QL block is believed to result from a spread of LA from its lumbar deposition cranially into the thoracic paravertebral space (TPVS), since Carney et al found traces of contrast agent in the TPVS following application of this block. Hence, the QL block would seem to be able to alleviate both somatic and visceral pain.10
The aim of this study is to compare between quadratus lumborum block, transversus abdominis plane block regarding perioperative analgesia after bladder cancer surgeries by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative.
Detailed description
Somatic post-surgical pain is very distressing to patients which leads to important complications. Combined multimodal strategies involving nerve blocks, neuroaxial blocks, opiates, and non-steroidal anti-inflammatory drugs are necessary for optimal pain control.
Transversus abdominis plane (TAP) block can be used to provide effective analgesia during the postoperative period following a range of surgeries.
TAP block administers local anesthetics between the T6 to L1 spinal nerve roots to stop the nerve signal and to alleviate pain for abdominal procedures.
A number of systematic reviews have assessed TAP block as a postoperative analgesic compared to one or more specific procedures.
Anterior abdominal wall blocks, as transverse abdominal plexus block, have an important role for only somatic intraoperative and postoperative pain control.
The viscera are innervated by the vagal nerve (parasympathetic innervation) and by the splanchnic nerves (sympathetic innervation). The splanchnic nerves carry both visceral efferent and afferent nerve fibers. The sensory (or afferent) part of the splanchnic nerves reach the spinal column at certain spinal segments, It is possible to block central visceral pain conduction with thoracic paravertebral blockade or maybe even with the novel quadratus lumborum (QL) block.
The effect of the QL block is believed to result from a spread of LA from its lumbar deposition cranially into the thoracic paravertebral space (TPVS), since Carney et al found traces of contrast agent in the TPVS following application of this block. Hence, the QL block would seem to be able to alleviate both somatic and visceral pain.10 Quadratus lumborum block was first described by Blanco in 2007. Blanco described a potential space posterior to the abdominal wall muscles and lateral to the quadratus lumborum muscle. It has been used in abdominoplasties, caesarean sections and lower abdominal operations providing complete pain relief in the distribution area from Th6 to L1 dermatomes. It may be seen as a lumbar approach to the Thoracic Paravertebral Space. The block apparently produces distribution of the local anesthetic extending proximally and over both sides of the surface of the QL muscle, in between the anterior and intermediate layers of the thoracolumbar fascia.
Quadratus lumborum muscle inserts on the lower border of the last rib and by four small tendons into the apices of the transverse processes of the upper four lumbar vertebrae.
Running between its fascia and the muscle are the twelfth thoracic (subcostal), ilioinguinal, and iliohypogastric nerves, The block does not rely on the feeling of any pops or fascial clicks because depending of the angle of the needle several pops can be felt without reaching the target zone, which is lateral to the quadratus lumborum muscle. Actually, the block has never been intended to be conducted without the use of US guidance, and the block is thus a purely USG block.
Aim of study Comparison between quadratus lumborum block, transversus abdominis plane block regarding perioperative analgesia after bladder cancer surgeries by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Intravenous opioidPatients will receive general anesthesia with intravenous opioid |
| Quadratus lumborum | Experimental | Procedure: Quadratus lumborum blockPatients will receive bilateral quadratus lumborum block |
| Transversus abdominis plane | Experimental | Procedure: Transversus abdominis plane blockPatients will receive bilateral transversus abdominis plane block |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of the patients between 20 to 80 years.
- ASA physical status II -III
- Elective bladder cancer operations.
Key exclusion criteria (7 listed)
- Patient refusal
- Local infection at the site of injection
- Allergy to study medications
- Sepsis
- Anatomic abnormalities
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 |
|---|---|---|
| Quadratus lumborum blockAlso: Group BThe patient will be placed in a lateral position with the side to be blocked facing upwards. The ultrasound probe will be properly sterilized and with sterile covers. An 18-20 gauge blunt tipped block needle or a Tuohy needle is advanced under ultrasound guidance on the posterior aspect of the Quadratus Lumborum. The QL muscle is identified with its attachment to the lateral edge of the transverse process of the L4 vertebral body. With the psoas major muscle anteriorly, the erector spinae muscle posteriorly and the QL muscle adherent to the apex of the transverse process, a well recognisable pattern of a shamrock with three leaves can be seen. | Procedure or surgery | Quadratus lumborum |
| Transversus abdominis plane blockAlso: Group CThe patient will be supine while performing the block and sterilization of the site of the ultrasound and needle entry will be performed. The ultrasound probe is placed in a transverse plane to the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest. The needle is introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles. | Procedure or surgery | Transversus abdominis plane |
| Intravenous opioidAlso: Group APatients will receive morphine 0.1 mg/kg | Drug | Control Group |
Primary outcome
Time to first rescue dose of morphine
Time frame: 24 hours
First time at which morphine was given postoperatively (If Vsual analogue scale (VAS) was >4, 3 mg morphine IV was administered as a rescue analgesia for the first 24 hours)
2 secondary outcomes
Total dose of postoperative morphine consumption
Time frame: 24 hours
Pain intensity by visual analogue scale (VAS)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No. I don't want to share
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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.
Ahmed M Mohammed, MSc principal investigator
Assistant lecturer of Anesthesia, ICU, and Pain Relief
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus lumborum block, Transversus abdominis plane block and Intravenous opioid in people with Quadratus Lumborum Block and Transversus Abdominis Plane Block, run by National Cancer Institute, Egypt 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Mohammed, MSc (+20 122 431 8828, mans.cerano@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first rescue dose of morphine (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 19 Oct 2020.