Cesarean SectionNCT05950568
Quadratus Lumborum Block Type III Versus Type II Versus Transversus Abdominis Plane Block in Cesarean Section
A study testing Quadratus lumborum block typen II, Quadratus lumborum block III and Transversus abdominis plane block in people with Cesarean Section and Quadratus Lumborum Block, run by The General Authority for Teaching Hospitals and Institutes at 1 site in Egypt.
Trial summary
Compare the type III and type II quadratus lumborum block (QLB) to transversus abdominis plane block (TAPB) regarding efficacy in CS Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section, Quadratus Lumborum Block, Transversus Abdominis Plane Block
- What is being tested?
- Quadratus lumborum block typen II, Quadratus lumborum block III and Transversus abdominis plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Mar 2023to 25 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status II
- aged 18 to 40 years old
- presenting for elective Cesarean section
Who cannot join
- body mass index (BMI) ≥40 kg/m2
- weight < 50kg
- height < 150 cm
- contraindications for the use of active labor, spinal anesthesia
- recent opiate intake
- hypersensitivity to any used medication
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- substantial cardiovascular diseases
- renal diseases
- hepatic, diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The General Authority for Teaching Hospitals and Institutes
Cairo, 11511
About this study
Official title: Efficacy of Quadratus Lumborum Block Type III Versus Type II Versus Transversus Abdominis Plane Block in Cesarean Section: A Randomized Controlled Multicenter Trial
Compare the type III and type II quadratus lumborum block (QLB) to transversus abdominis plane block (TAPB) regarding efficacy in CS
Read the detailed description
The transversus abdominis plane block (TAPB) is administered between the internal oblique muscle and the transversus abdominis muscle in the fascial plane, directly pointing to the somatic nerves T6-L1 that run in this plane. In addition, meta-analyses demonstrate that it is an effective analgesic for somatic pain and diminishes opiate intake. It has been reported that TAPB is an efficient analgesic approach following cesarean section .
The quadratus lumborum (QL) muscle block (QLB) is a fascial plane block as local anesthetic (LA) is introduced nearby to the QL muscle to numb the thoracolumbar nerves. QLB is categorized into four types according to drug administration location, I (lateral), II (posterior), III (anterior/transmuscular), and Intravenous, (intramuscular). QLB can effectively decrease both visceral and somatic pain by LA distribution to the thoracic paravertebral space (TPVS), as this block ensures effective pain control from the T7 to L1 dermatomes. QLB is one of the regional techniques that provides the greatest benefit in post-CS pain control, as it is progressively applied in obstetric anesthetic precise to improve analgesic results.
- Being tested
- Quadratus lumborum block typen II, Quadratus lumborum block III, Transversus abdominis plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum block typen IIProcedure or surgery
A 22 gauge needle was positioned between the quadratus lumborum muscle posterior border and the erector spinae muscle in the thoracolumbar fascia's middle layer
Quadratus lumborum block IIIProcedure or surgery
A 22 gauge needle was positioned between the psoas and quadratus lumborum muscles at the anterior fascia lumbosacral
Transversus abdominis plane blockProcedure or surgery
A 22 gauge needle was positioned between the internal oblique and transversus abdominis muscles
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block type II | Active comparator | A 22 gauge needle was positioned between the erector spinae muscle in the thoracolumbar fascia's middle layer Receives: Procedure: Quadratus lumborum block typen II |
| Quadratus lumborum block type III | Active comparator | A 22 gauge needle was positioned between the psoas and quadratus lumborum muscles at the anterior fascia lumbosacral Receives: Procedure: Quadratus lumborum block III |
| Transversus abdominis plane block | Active comparator | A 22 gauge needle was positioned between the internal oblique and transversus abdominis muscles Receives: Procedure: Transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative consumed pethidine
Numerical rating scales (NRS) score was evaluated at Post Anesthesia Care Unit (PACU), 2, 4, 6, 8, 12, 18, and 24 hours as as 0 is no pain and 10 is the worst pain imaginable. If the NRS score remained ≥ 4, we provided a bolus pethidine (0.5 mg/kg intravenous) and repeatable after 30 minutes if NRS remains≥ 4.
Measured: 24 hour postoperatively
Secondary outcomes (3)
Time of the first analgesic request
If the Numerical rating scales (NRS) score remained ≥ 4, we provided a bolus pethidine (0.5 mg/kg intravenous).
Measured: 24 hour postoperatively
Patient satisfaction
The level of patient satisfaction was graded on a 5-point Likert scale as 0= extremely dissatisfied, 1= dissatisfied, 2= neither satisfied nor dissatisfied, 3= satisfied, 4= extremely satisfied
Measured: 24 hour postoperatively
The degree of postoperative pain
Numerical rating scales (NRS ) score was evaluated at Post Anesthesia Care Unit (PACU), 2, 4, 6, 8, 12, 18, and 24 hours as as 0 is no pain and 10 is the worst pain imaginable.
Measured: 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start24 Mar 2023
- Primary completion25 Jun 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The General Authority for Teaching Hospitals and Institutes
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Abeer Ali Elshabacy, The General Authority for Teaching Hospitals and Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950568
- Sponsor's protocol ID
- HB000132
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Quadratus Lumborum Block Type III Versus Type II Versus Transversus Abdominis Plane Block in Cesarean Section: A Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT05950568
- Acronym / sponsor ID
- HB000132
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The General Authority for Teaching Hospitals and InstitutesResearch network
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 18 Jul 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.
Compare the type III and type II quadratus lumborum block (QLB) to transversus abdominis plane block (TAPB) regarding efficacy in CS
Detailed description
The transversus abdominis plane block (TAPB) is administered between the internal oblique muscle and the transversus abdominis muscle in the fascial plane, directly pointing to the somatic nerves T6-L1 that run in this plane. In addition, meta-analyses demonstrate that it is an effective analgesic for somatic pain and diminishes opiate intake. It has been reported that TAPB is an efficient analgesic approach following cesarean section .
The quadratus lumborum (QL) muscle block (QLB) is a fascial plane block as local anesthetic (LA) is introduced nearby to the QL muscle to numb the thoracolumbar nerves. QLB is categorized into four types according to drug administration location, I (lateral), II (posterior), III (anterior/transmuscular), and Intravenous, (intramuscular). QLB can effectively decrease both visceral and somatic pain by LA distribution to the thoracic paravertebral space (TPVS), as this block ensures effective pain control from the T7 to L1 dermatomes. QLB is one of the regional techniques that provides the greatest benefit in post-CS pain control, as it is progressively applied in obstetric anesthetic precise to improve analgesic results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum block type II | Active comparator | Procedure: Quadratus lumborum block typen IIA 22 gauge needle was positioned between the erector spinae muscle in the thoracolumbar fascia's middle layer |
| Quadratus lumborum block type III | Active comparator | Procedure: Quadratus lumborum block IIIA 22 gauge needle was positioned between the psoas and quadratus lumborum muscles at the anterior fascia lumbosacral |
| Transversus abdominis plane block | Active comparator | Procedure: Transversus abdominis plane blockA 22 gauge needle was positioned between the internal oblique and transversus abdominis muscles |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status II
- aged 18 to 40 years old
- presenting for elective Cesarean section
Key exclusion criteria (9 listed)
- body mass index (BMI) ≥40 kg/m2
- weight < 50kg
- height < 150 cm
- contraindications for the use of active labor, spinal anesthesia
- recent opiate intake
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 block typen IIA 22 gauge needle was positioned between the quadratus lumborum muscle posterior border and the erector spinae muscle in the thoracolumbar fascia's middle layer | Procedure or surgery | Quadratus lumborum block type II |
| Quadratus lumborum block IIIA 22 gauge needle was positioned between the psoas and quadratus lumborum muscles at the anterior fascia lumbosacral | Procedure or surgery | Quadratus lumborum block type III |
| Transversus abdominis plane blockA 22 gauge needle was positioned between the internal oblique and transversus abdominis muscles | Procedure or surgery | Transversus abdominis plane block |
Primary outcome
Total postoperative consumed pethidine
Time frame: 24 hour postoperatively
Numerical rating scales (NRS) score was evaluated at Post Anesthesia Care Unit (PACU), 2, 4, 6, 8, 12, 18, and 24 hours as as 0 is no pain and 10 is the worst pain imaginable. If the NRS score remained ≥ 4, we provided a bolus pethidine (0.5 mg/kg intravenous) and repeatable after 30 minutes if NRS remains≥ 4.
3 secondary outcomes
Time of the first analgesic request
Time frame: 24 hour postoperatively
Patient satisfaction
Time frame: 24 hour postoperatively
The degree of postoperative pain
Time frame: 24 hour 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 25 Jul 2023.
- 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 Quadratus lumborum block typen II, Quadratus lumborum block III and Transversus abdominis plane block in people with Cesarean Section and Quadratus Lumborum Block, run by The General Authority for Teaching Hospitals and Institutes 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 25 Jul 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?
Total postoperative consumed pethidine (time frame: 24 hour 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 25 Jul 2023.