Regional BlockquadratusNCT04773730
Quadratus Lumborum Block Type 2 Versus Posterior Transversus Abdominus Plane Block
A study testing Posterior transversus abdominus plane block and Quadratus lumborum block type 2 in people with Regional Block, run by Mansoura University at 1 site in Egypt.
Trial summary
This patient population are at risk of adverse effects secondary to inadequate pain management such as inadequate maternal bonding and late ambulation. Regional analgesia is preferred due to their opioid sparing effects and reduction in related adverse effects but the analgesia from these blocks is not known which one… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Regional Block
- What is being tested?
- Posterior transversus abdominus plane block and Quadratus lumborum block type 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2021to 3 Jun 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status II parturient.
- Singleton pregnancies with a gestation of at least 37 weeks.
- Patients undergoing spinal anesthesia for cesarean deliveryvia a Pfannenstiel incision with exteriorization of the uterus.
Who cannot join
- Age < 19 or > 40 years.
- Height<150 cm, weight < 60 kg, body mass index (BMI) ≥35 kg/m2.
- Inability to comprehend or participatein pain scoring system.
- Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
- Hypersensitivity to any drugused in the study.
- Hypertensive disorders of pregnancy.
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- Renal impairment or other contraindication to non-steroidal anti-inflammatory drugs.
- Significant cardiovascular, renal or hepatic abnormalities.
- Patients with history of opoid intake, drug abusers, psychiatric patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Quadratus Lumborum Block Type 2 and Posterior Transversus Abdominus Plane Block for Analgesia After Cesarean Delivery Under Spinal Anesthesia
This patient population are at risk of adverse effects secondary to inadequate pain management such as inadequate maternal bonding and late ambulation.
Regional analgesia is preferred due to their opioid sparing effects and reduction in related adverse effects but the analgesia from these blocks is not known which one is superior to the other in the context of cesarean section
Read the detailed description
The aim of this study is to compare the effect of posterior transversus abdominus plane block and quadratus lumborum type 2 for cesarean delivery.
The transversus abdominus plane(TAP) block provides sensory block from T6 to L1 for lower abdominal surgeries.
Quadratous lumborum type 2 block, the injection is posterior to the quadratus lumborum muscle. This method has the advantage of a more superficial point of injection with better ultrasonographic resolution.
Only one RCT was done in this context by Kalpana Verma and his colleagues comparing quadratus lumborum type 2 and posterior transversus abdominus plane block. That shows marked discrepancy with time to first analgesic request from the quadratus lumborum block in other abdominal surgeries
- Conditions
- Regional Block
- Being tested
- Posterior transversus abdominus plane block, Quadratus lumborum block type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior transversus abdominus plane blockProcedure or surgery
Twenty mL of bupivacaine 0.25% will be injected in the plane between the transverses abdominus muscle and the fascia deep to the internal oblique muscle on each side
Quadratus lumborum block type 2Procedure or surgery
Twenty mL of bupivacaine 0.25% will be injected on the posterior surface of quadrates lumborum muscle on each side
| Study group | Role | What they receive |
|---|---|---|
| Posterior transversus abdominus block | Active comparator | After the surgery end and while the patient in the supine position, with the side to be blocked is elevated
A 12-14 MHz linear array transducer will be placed transversely between the iliac crest and costal margin then slided from medial-lateral to visualize the posterior most part of the external oblique, internal oblique, and transversus abdominus muscles
Then 20 mL of bupivacaine0.25% will be injected between the transverses abdominus muscle and the fascia deep to the internal oblique muscle
The same steps will be repeated on the other side Receives: Procedure: Posterior transversus abdominus plane block |
| Quadratus lumborum block type 2 | Active comparator | After the surgery end and while the patient in the supine position, with the side to be blocked is elevated
A2-5 MHz curved array transducer will be placed at the level of the antero-superior iliac spine then the external oblique muscle will be followed posterolaterally until its posterior border will be visualized The probe will be tilted down to identify a bright hyperechoic line After that 20 mL of bupivacaine 0.25% will be injected under direct visualization on the posterior surface of quadrates lumborum muscle
The same steps will be repeated on the other side Receives: Procedure: Quadratus lumborum block type 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The analgesic duration
the time measured from finishing the block till the first request of analgesia by the patient
Measured: within 24 hours after the surgery
Secondary outcomes (8)
Postoperative pain at rest
100 centimetres visual analog scale (VAS) for pain, where zero is equal to no pain and hundred indicates the worst possible pain
Measured: immediately and 1,2,3,4hour at postanesthesia care unit, then in the surgical ward at 6,8,10,12,18 and 24 h
Postoperative pain on movement (attempted hip flexion) or coughing
100 centimetres visual analog scale (VAS) for pain, where zero is equal to no pain and hundred indicates the worst possible pain
Measured: immediately and 1,2,3,4hour at postanesthesia care unit, then in the surgical ward at 6,8,10,12,18 and 24 h
Patient satisfaction
poor= 1, fair = 2, good = 3, excellent = 4
Measured: 24 hours after surgery
Heart rate
beat per minute
Measured: at 1st, 2nd, 3rd, 4th, 10th, 16th and 22nd hours postoperatively
Non-invasive blood pressure
mmHg
Measured: at 1st, 2nd, 3rd, 4th, 10th, 16th and 22nd hours postoperatively
Total postoperative analgesic consumption of of ketolac, paracetamol and fentanyl
Patients with visual analog scale more than 30 will receive 30 mg of intravenous ketolac in addition to 1gm paracetamol which will be repeated every 8 hours intravenous infusion of every 8 hours. Intravenous administration of fentanyl bolus doses of 0.5 µg per kg per dose will be given if the visual analog scale remains more than 30
Measured: within the first 24 hours after surgery
Postoperative nausea and vomiting
0= none, 1= mild, 2= moderate and 3= sever
Measured: within 24 hours after surgery
Postoperative lower limb weakness
reported by the patient during her first walk after surgery
Measured: within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start15 Mar 2021
- Primary completion1 Aug 2022
- Study completion3 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional BlockStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients will be randomly allocated via sealed opaque envelop into 2 groups of 50 patients each; Posterior transversus abdominus block (TAP) group and Quadratus lumborum block type 2 is the second group (QLB)group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
- Investigators
- Maha Ahmed Abozeid, MD, Study director, Faculty of Medicine - Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773730
- Sponsor's protocol ID
- regional block
- Acronym
- quadratus
- Status last verified
- Jun 2023
- First submitted
- 20 Feb 2021
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Quadratus Lumborum Block Type 2 and Posterior Transversus Abdominus Plane Block for Analgesia After Cesarean Delivery Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT04773730
- Acronym / sponsor ID
- quadratus / regional block
- Conditions
- Regional Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 3 Jun 2023 (actual)
- First posted
- 26 Feb 2021 (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.
This patient population are at risk of adverse effects secondary to inadequate pain management such as inadequate maternal bonding and late ambulation.
Regional analgesia is preferred due to their opioid sparing effects and reduction in related adverse effects but the analgesia from these blocks is not known which one is superior to the other in the context of cesarean section
Detailed description
The aim of this study is to compare the effect of posterior transversus abdominus plane block and quadratus lumborum type 2 for cesarean delivery.
The transversus abdominus plane(TAP) block provides sensory block from T6 to L1 for lower abdominal surgeries.
Quadratous lumborum type 2 block, the injection is posterior to the quadratus lumborum muscle. This method has the advantage of a more superficial point of injection with better ultrasonographic resolution.
Only one RCT was done in this context by Kalpana Verma and his colleagues comparing quadratus lumborum type 2 and posterior transversus abdominus plane block. That shows marked discrepancy with time to first analgesic request from the quadratus lumborum block in other abdominal surgeries
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- patients will be randomly allocated via sealed opaque envelop into 2 groups of 50 patients each; Posterior transversus abdominus block (TAP) group and Quadratus lumborum block type 2 is the second group (QLB)group
| Arm | Type | Receives |
|---|---|---|
| Posterior transversus abdominus block | Active comparator | Procedure: Posterior transversus abdominus plane blockAfter the surgery end and while the patient in the supine position, with the side to be blocked is elevated A 12-14 MHz linear array transducer will be placed transversely between the iliac crest and costal margin then slided from medial-lateral to visualize the posterior most part of the external oblique, internal oblique, and transversus abdominus muscles Then 20 mL of bupivacaine0.25% will be injected between the transverses abdominus muscle and the fascia deep to the internal oblique muscle The same steps will be repeated on the other side |
| Quadratus lumborum block type 2 | Active comparator | Procedure: Quadratus lumborum block type 2After the surgery end and while the patient in the supine position, with the side to be blocked is elevated A2-5 MHz curved array transducer will be placed at the level of the antero-superior iliac spine then the external oblique muscle will be followed posterolaterally until its posterior border will be visualized The probe will be tilted down to identify a bright hyperechoic line After that 20 mL of bupivacaine 0.25% will be injected under direct visualization on the posterior surface of quadrates lumborum muscle The same steps will be repeated on the other side |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status II parturient.
- Singleton pregnancies with a gestation of at least 37 weeks.
- Patients undergoing spinal anesthesia for cesarean deliveryvia a Pfannenstiel incision with exteriorization of the uterus.
Key exclusion criteria (9 listed)
- Age < 19 or > 40 years.
- Height<150 cm, weight < 60 kg, body mass index (BMI) ≥35 kg/m2.
- Inability to comprehend or participatein pain scoring system.
- Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
- Hypersensitivity to any drugused in the study.
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 |
|---|---|---|
| Posterior transversus abdominus plane blockTwenty mL of bupivacaine 0.25% will be injected in the plane between the transverses abdominus muscle and the fascia deep to the internal oblique muscle on each side | Procedure or surgery | Posterior transversus abdominus block |
| Quadratus lumborum block type 2Twenty mL of bupivacaine 0.25% will be injected on the posterior surface of quadrates lumborum muscle on each side | Procedure or surgery | Quadratus lumborum block type 2 |
Primary outcome
The analgesic duration
Time frame: within 24 hours after the surgery
the time measured from finishing the block till the first request of analgesia by the patient
8 secondary outcomes
Postoperative pain at rest
Time frame: immediately and 1,2,3,4hour at postanesthesia care unit, then in the surgical ward at 6,8,10,12,18 and 24 h
Postoperative pain on movement (attempted hip flexion) or coughing
Time frame: immediately and 1,2,3,4hour at postanesthesia care unit, then in the surgical ward at 6,8,10,12,18 and 24 h
Patient satisfaction
Time frame: 24 hours after surgery
Heart rate
Time frame: at 1st, 2nd, 3rd, 4th, 10th, 16th and 22nd hours postoperatively
Non-invasive blood pressure
Time frame: at 1st, 2nd, 3rd, 4th, 10th, 16th and 22nd hours postoperatively
Total postoperative analgesic consumption of of ketolac, paracetamol and fentanyl
Time frame: within the first 24 hours after surgery
Postoperative nausea and vomiting
Time frame: within 24 hours after surgery
Postoperative lower limb weakness
Time frame: within 24 hours after surgery
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 6 Jun 2023.
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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.
Maha Ahmed Abozeid, MD study director
Faculty of Medicine - Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior transversus abdominus plane block and Quadratus lumborum block type 2 in people with Regional Block, run by Mansoura 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 3 inclusion and 9 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 6 Jun 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 analgesic duration (time frame: within 24 hours after the surgery). 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 6 Jun 2023.