Erector Spinae Plane BlockNCT05713643
ESPB vs PVB vs QLB After Pelvi-ureteric Surgeries
A study testing ESPB Technique, TPVB Technique and QLB Technique in people with Erector Spinae Plane Block and Paravertebral Block, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the analgesic efficacy of erector spinae plane block versus thoracic paravertebral block versus quadratus lumborum block on postoperative analgesia after pelvi-ureteric surgeries. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Erector Spinae Plane Block, Paravertebral Block, Quadratus Lumborum Block
- What is being tested?
- ESPB Technique, TPVB Technique and QLB Technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2023to 5 Nov 2023
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Both genders
- American Society of Anesthesiologists (ASA) physical status I-III
- Undergoing elective pelvi-ureteric surgeries.
Who cannot join
- Body Mass Index > 30 kg/m2.
- Contraindication of deep nerve block such as allergic to anesthetic drug, coagulation disorder, and infection at the injection site.
- Chronic opioids dependence or chronic pain over 3 months.
- Use of medication such as gabapentin-pregabalin could affect pain perception.
- Unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder.
- Unable to perform nerve block procedure due to difficult anatomy through ultrasound scan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block Versus Paravertebral Block Versus Quadratus Lumborum Block on Postoperative Analgesia After Pelvi-ureteric Surgeries: A Randomized Double-Blinded, Non-inferiority Trial
The aim of this study is to compare the analgesic efficacy of erector spinae plane block versus thoracic paravertebral block versus quadratus lumborum block on postoperative analgesia after pelvi-ureteric surgeries.
Read the detailed description
Opioid-based analgesia plays a significant role in the control of postsurgical pain; however, use of opioid may lead to significant side effects (e.g., nausea and vomiting) and adverse events (e.g. respiratory depression), which may be associated with significantly longer hospital stays and higher hospital costs in the postsurgical setting .
Thoracic paravertebral block (TPVB) is a classic trunk block with definite analgesic effect for both somatic and visceral pain.
Quadratus Lumborum block (QLB) is a widely used regional anesthesia technique as well. It has been used for reducing postoperative pain after cesarean section, laparotomy or laparoscopic procedure and hip surgery.
Erector spinae plane block (ESPB) is a novel inter-fascial plane block first introduced by Forero et al. in 2016 , providing wide-ranging analgesia in lung surgery, laparoscopy, mastectomy, and pediatric surgery. The proposed mechanism of ESPB is that distribution of local anesthetic solution spreads into the para-vertebral space and epidural space, which then blocks the dorsal, ventral, and traffic branches of spinal nerve.
ESPB, TPVB and QLB III have been shown to improve analgesic outcome after urological surgeries.
- Being tested
- ESPB Technique, TPVB Technique, QLB Technique
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPB TechniqueProcedure or surgery
The patient will be in sitting position. The probe will be positioned with longitudinal alignment, 3 cm lateral to the spinous procedure of T8 to obtain a parasagittal view. An echogenic needle will be introduced from the caudal end of the probe and advanced in-plane direction until the needle tip hit the tip of the transverse process. Bupivacaine will be afterwards injected into the erector spinae plane block. Linear spread cranially and caudally below the muscle upon injection will be visualized on the US screen indicating successful block.
TPVB TechniqueProcedure or surgery
The patient will be in sitting position. The probe will be positioned with longitudinal alignment, 3 cm lateral and parallel to 8th spinous process till transverse process, superior costotransverse ligament, and pleura will be visualized then lateral tilt of the probe was done for better visualization of the PVS between the superior costotransverse ligament and the pleura. An echogenic needle was introduced at caudal end of transducer using the in-plane technique till piercing the superior costotransverse ligament . Bupivacaine will be injected into the PVS with downward displacement of the pleura indicating a successful block.
QLB TechniqueProcedure or surgery
The patient will be in lateral position. The probe will be placed above the iliac crest. The Petit's triangle will be identified. The three abdominal muscles (i.e., the external oblique, internal oblique and transversus abdominus muscles) will be detected. Both the external oblique and internal oblique muscles will be followed posteriorly until the layers of the thoracolumbar fascia appear as a bright hyperechogenic line. The quadratus lumborum muscle appears below to the latissimus dorsi muscle. While performing the quadratus lumborum block, "Shamrock sign" is identified; the transverse process of L4 appears as a stem whereas the three muscles psoas muscle, quadratus lumborum muscle and erector spinae appear as the leaves. A 22G (50mm) needle was inserted using an in-plane technique along the posterior edge of the ultrasound probe in the anteromedial direction. The needle tip was placed between the quadratus lumborum muscle and the Erector spinae muscle.
| Study group | Role | What they receive |
|---|---|---|
| ESPB group | Active comparator | Not described Receives: Procedure: ESPB Technique |
| TPVB group | Active comparator | Not described Receives: Procedure: TPVB Technique |
| QLB group | Active comparator | Not described Receives: Procedure: QLB Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total postoperative morphine consumption
Total amount of rescue analgesic in the first 48 hours postoperative will be measured.
Measured: 48 hours postoperatively
Secondary outcomes (3)
Access post-operative pain scores
Postoperative pain will be accessed using Numeric Rating Scale which ranges from 0 to 10 points, with 0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain.
Measured: 48 hours Postoperatively
Access time of first analgesic
The time to first request of rescue analgesia will be recorded
Measured: 48 hours Postoperatively
Patients' satisfaction after surgery.
The degree of patient satisfaction will be assessed on a 5-point scale: (0= extremely dissatisfied, 1= unsatisfied, 2= neither satisfied nor unsatisfied, 3= satisfied), 4= extremely satisfied).
Measured: 48 hours Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start30 Jan 2023
- Primary completion5 Nov 2023
- Study completion5 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fouad Algyar, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713643
- Sponsor's protocol ID
- MKSU 50-12-12
- Status last verified
- Nov 2023
- First submitted
- 26 Jan 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available under a reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Paravertebral Block Versus Quadratus Lumborum Block on Postoperative Analgesia After Pelvi-ureteric Surgeries: A Randomized Double-Blinded, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05713643
- Acronym / sponsor ID
- MKSU 50-12-12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 5 Nov 2023 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 6 Feb 2023 (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 aim of this study is to compare the analgesic efficacy of erector spinae plane block versus thoracic paravertebral block versus quadratus lumborum block on postoperative analgesia after pelvi-ureteric surgeries.
Detailed description
Opioid-based analgesia plays a significant role in the control of postsurgical pain; however, use of opioid may lead to significant side effects (e.g., nausea and vomiting) and adverse events (e.g. respiratory depression), which may be associated with significantly longer hospital stays and higher hospital costs in the postsurgical setting .
Thoracic paravertebral block (TPVB) is a classic trunk block with definite analgesic effect for both somatic and visceral pain.
Quadratus Lumborum block (QLB) is a widely used regional anesthesia technique as well. It has been used for reducing postoperative pain after cesarean section, laparotomy or laparoscopic procedure and hip surgery.
Erector spinae plane block (ESPB) is a novel inter-fascial plane block first introduced by Forero et al. in 2016 , providing wide-ranging analgesia in lung surgery, laparoscopy, mastectomy, and pediatric surgery. The proposed mechanism of ESPB is that distribution of local anesthetic solution spreads into the para-vertebral space and epidural space, which then blocks the dorsal, ventral, and traffic branches of spinal nerve.
ESPB, TPVB and QLB III have been shown to improve analgesic outcome after urological surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESPB group | Active comparator | Procedure: ESPB Technique |
| TPVB group | Active comparator | Procedure: TPVB Technique |
| QLB group | Active comparator | Procedure: QLB Technique |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- Both genders
- American Society of Anesthesiologists (ASA) physical status I-III
- Undergoing elective pelvi-ureteric surgeries.
Key exclusion criteria (6 listed)
- Body Mass Index > 30 kg/m2.
- Contraindication of deep nerve block such as allergic to anesthetic drug, coagulation disorder, and infection at the injection site.
- Chronic opioids dependence or chronic pain over 3 months.
- Use of medication such as gabapentin-pregabalin could affect pain perception.
- Unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder.
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 |
|---|---|---|
| ESPB TechniqueThe patient will be in sitting position. The probe will be positioned with longitudinal alignment, 3 cm lateral to the spinous procedure of T8 to obtain a parasagittal view. An echogenic needle will be introduced from the caudal end of the probe and advanced in-plane direction until the needle tip hit the tip of the transverse process. Bupivacaine will be afterwards injected into the erector spinae plane block. Linear spread cranially and caudally below the muscle upon injection will be visualized on the US screen indicating successful block. | Procedure or surgery | ESPB group |
| TPVB TechniqueThe patient will be in sitting position. The probe will be positioned with longitudinal alignment, 3 cm lateral and parallel to 8th spinous process till transverse process, superior costotransverse ligament, and pleura will be visualized then lateral tilt of the probe was done for better visualization of the PVS between the superior costotransverse ligament and the pleura. An echogenic needle was introduced at caudal end of transducer using the in-plane technique till piercing the superior costotransverse ligament . Bupivacaine will be injected into the PVS with downward displacement of the pleura indicating a successful block. | Procedure or surgery | TPVB group |
| QLB TechniqueThe patient will be in lateral position. The probe will be placed above the iliac crest. The Petit's triangle will be identified. The three abdominal muscles (i.e., the external oblique, internal oblique and transversus abdominus muscles) will be detected. Both the external oblique and internal oblique muscles will be followed posteriorly until the layers of the thoracolumbar fascia appear as a bright hyperechogenic line. The quadratus lumborum muscle appears below to the latissimus dorsi muscle. While performing the quadratus lumborum block, "Shamrock sign" is identified; the transverse process of L4 appears as a stem whereas the three muscles psoas muscle, quadratus lumborum muscle and erector spinae appear as the leaves. A 22G (50mm) needle was inserted using an in-plane technique along the posterior edge of the ultrasound probe in the anteromedial direction. The needle tip was placed between the quadratus lumborum muscle and the Erector spinae muscle. | Procedure or surgery | QLB group |
Primary outcome
The total postoperative morphine consumption
Time frame: 48 hours postoperatively
Total amount of rescue analgesic in the first 48 hours postoperative will be measured.
3 secondary outcomes
Access post-operative pain scores
Time frame: 48 hours Postoperatively
Access time of first analgesic
Time frame: 48 hours Postoperatively
Patients' satisfaction after surgery.
Time frame: 48 hours Postoperatively
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 22 Nov 2023.
- Individual participant dataSharing planned: Yes. The data will be available under a reasonable request from the corresponding author.
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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 ESPB Technique, TPVB Technique and QLB Technique in people with Erector Spinae Plane Block and Paravertebral Block, run by Kafrelsheikh University 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 22 Nov 2023. 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 total postoperative morphine consumption (time frame: 48 hours postoperatively). 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 22 Nov 2023.