Regional Anesthesia BlockNCT06874569
A Comparing Transversalis Fascia Plane Block and Quadratus Lumborum Block for Post-Cesarean Pain Management: Efficacy, Execution Time, and Practicality
A study testing TAP Block:, TFP Block: and QLB: in people with Regional Anesthesia Block, run by Aswan University at 1 site in Egypt.
Trial summary
Transversalis Fascia Plane Block (TFPB) and Quadratus Lumborum Block (QLB) provide superior analgesia to Transversus Abdominis Plane Block (TAPB) for post-cesarean pain management. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia Block
- What is being tested?
- TAP Block:, TFP Block: and QLB:
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 15 Dec 2024
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women aged 20-40 years scheduled for elective cesarean delivery under spinal anesthesia .
- American Society of Anesthesiologists (ASA) physical status of II
- Body mass index (BMI) of less than 35 kg/m² .
Who cannot join
- History of allergy to local anesthetics.
- Contraindications to regional anesthesia (such as coagulopathy or infection at the injection site).
- Severe systemic diseases (renal, hepatic, or cardiovascular dysfunction).
- weight less than 50 kg (to avoid exceeding safe doses of local anesthetic).
- pregnancy complications like severe preeclampsia, eclampsia, or postpartum hemorrhage.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assistant Professor and the Principle Investigator
Transversalis Fascia Plane Block (TFPB) and Quadratus Lumborum Block (QLB) provide superior analgesia to Transversus Abdominis Plane Block (TAPB) for post-cesarean pain management. This study evaluates whether TFPB or QLB is preferable when their analgesic efficacy is nearly equal, focusing on ease of performance and execution time.
Read the detailed description
Cesarean delivery is one of the most common surgical procedures worldwide and is associated with significant postoperative pain that includes both somatic and visceral components . Effective pain management not only enhances patient comfort and satisfaction but also facilitates early mobilization and reduces maternal morbidity . Although the Transversus Abdominis Plane (TAP) block is widely used as part of a multimodal analgesia strategy, its relatively short duration of action and limited ability to relieve visceral pain have prompted the search for improved alternatives .
Recent advancements in ultrasound-guided regional anesthesia have introduced the Quadratus Lumborum Block (QLB) and the Transversalis Fascia Plane Block (TFPB) as promising techniques for post-cesarean analgesia. The QLB, first described by Blanco (2007) , offers extended analgesia due to its paravertebral spread, thereby addressing both somatic and visceral pain . In contrast, TFPB targets the transversalis fascia to block the T12 and L1 nerves, effectively reducing postoperative pain following cesarean delivery . Although both QLB and TFPB have been shown to provide superior analgesia compared to TAP blocks , limited data exist regarding their comparative ease of performance and procedural efficiency.
Given that the analgesic efficacy of TFPB and QLB appears comparable, it is essential to evaluate additional factors such as the time required to perform the block and the technical ease of the procedure. These factors are particularly critical in high-volume obstetric settings, where efficiency can significantly impact clinical workflow . Therefore, this study aims to compare TFPB and QLB not only in terms of analgesic efficacy but also regarding ease of performance and execution time, to determine which technique may be preferable for post-cesarean analgesia.
- Conditions
- Regional Anesthesia Block
- Being tested
- TAP Block:, TFP Block:, QLB:
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP Block:Procedure or surgery
TAP Block: A linear high-frequency probe (6-13 MHz) was placed transversely along the midaxillary line to visualize the external oblique, internal oblique, and transversus abdominis muscles. Using an in-plane approach, a 21G SonoPlex, STIM (PAJUNK, Germany), was advanced, and after hydro-dissection with 1-2 mL saline, 20 mL of 0.25% bupivacaine (Marcaine, AstraZeneca, Sweden) was injected into the plane between the internal oblique and transversus abdominis muscles.
TFP Block:Procedure or surgery
TFP Block: With a linear probe, the transversalis fascia was identified between the internal oblique and transversus abdominis muscles. An in-plane technique was used to insert a 21G needle, and following confirmation of correct placement with hydro-dissection, 20 mL of 0.25% bupivacaine was administered bilaterally.
QLB:Procedure or surgery
QLB: A low-frequency curvilinear probe (2-5 MHz) was used to identify the quadratus lumborum muscle and adjacent structures. The needle was advanced in-plane until it reached the targeted region adjacent to the quadratus lumborum, where after hydro-dissection, 20 mL of 0.25% bupivacaine was injected bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| TAP Block | Active comparator | TAP Block: A linear high-frequency probe (6-13 MHz) was placed transversely along the midaxillary line to visualize the external oblique, internal oblique, and transversus abdominis muscles. Using an in-plane approach, a 21G SonoPlex, STIM (PAJUNK, Germany), was advanced, and after hydro-dissection with 1-2 mL saline, 20 mL of 0.25% bupivacaine (Marcaine, AstraZeneca, Sweden) was injected into the plane between the internal oblique and transversus abdominis muscles. Receives: Procedure: TAP Block: |
| TFP Block | Experimental | TFP Block: With a linear probe, the transversalis fascia was identified between the internal oblique and transversus abdominis muscles. An in-plane technique was used to insert a 21G needle, and following confirmation of correct placement with hydro-dissection, 20 mL of 0.25% bupivacaine was administered bilaterally. Receives: Procedure: TFP Block: |
| QLB: | Experimental | QLB: A low-frequency curvilinear probe (2-5 MHz) was used to identify the quadratus lumborum muscle and adjacent structures. The needle was advanced in-plane until it reached the targeted region adjacent to the quadratus lumborum, where after hydro-dissection, 20 mL of 0.25% bupivacaine was injected bilaterally. Receives: Procedure: QLB: |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain by Numeric Pain Rating Scale
The primary outcome, postoperative pain, was assessed using the Numeric Pain Rating Scale (NRS) at predefined intervals: 6, 12, and 24 hours postoperatively. Pain scores were documented by trained nursing staff blinded to the intervention. Opioid administration was standardized-patients received nalbuphine in 2 mg increments as needed (NRS more than 4), with a maximum dose of 10 mg in 24 hours.Minimum score 0 (no pain) and maximum 10 (severe pain). The lower the number the more free pain and the more high scale the more pain present.
Measured: 6 ,12 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Oct 2023
- Primary completion1 Oct 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Regional Anesthesia 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
- Model description
- Participants were randomized into three equal groups (n = 36 per group) to receive either Transversus Abdominis Plane Block (TAPB, control), Transversalis Fascia Plane Block (TFPB), or Quadratus Lumborum Block (QLB). A computer-generated randomization sequence was used, and group allocations were concealed in sealed opaque envelopes, which were opened only after enrollment. Although the anesthesiologist performing the block knew the group allocation, patients and outcome assessors were blinded to minimize bias.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Collaborators
- Aswan University Hospital
- Responsible party
- Principal investigator, Ayman Mohamady Eldemrdash, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874569
- Sponsor's protocol ID
- regional block post C-section
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferguson JE, Tubog TD, Johnson W, Evans H, Furstein J. Quadratus Lumborum Block and Transversus Abdominis Plane Block in Non-emergency Cesarean Delivery: A Systematic Review and Meta-analysis. J Perianesth Nurs. 2024 Apr;39(2):226-234. doi: 10.1016/j.jopan.2023.07.017. Epub 2023 Oct 20.
PubMed 37865903Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
PubMed 27755488Benedicta R, Jain MK, Dixit N, Shivappagoudar VM. The Efficacy of Ultrasound-guided Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Lower-Segment Cesarean Section with Low-Dose Bupivacaine: A Randomized Controlled Trial. Anesth Essays Res. 2022 Apr-Jun;16(2):203-207. doi: 10.4103/aer.aer_84_22. Epub 2022 Sep 6.
PubMed 36447913
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Professor and the Principle Investigator
- ClinicalTrials.gov ID
- NCT06874569
- Acronym / sponsor ID
- regional block post C-section
- Conditions
- Regional Anesthesia Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Collaborators
- Aswan University Hospital
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 13 Mar 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.
Transversalis Fascia Plane Block (TFPB) and Quadratus Lumborum Block (QLB) provide superior analgesia to Transversus Abdominis Plane Block (TAPB) for post-cesarean pain management. This study evaluates whether TFPB or QLB is preferable when their analgesic efficacy is nearly equal, focusing on ease of performance and execution time.
Detailed description
Cesarean delivery is one of the most common surgical procedures worldwide and is associated with significant postoperative pain that includes both somatic and visceral components . Effective pain management not only enhances patient comfort and satisfaction but also facilitates early mobilization and reduces maternal morbidity . Although the Transversus Abdominis Plane (TAP) block is widely used as part of a multimodal analgesia strategy, its relatively short duration of action and limited ability to relieve visceral pain have prompted the search for improved alternatives .
Recent advancements in ultrasound-guided regional anesthesia have introduced the Quadratus Lumborum Block (QLB) and the Transversalis Fascia Plane Block (TFPB) as promising techniques for post-cesarean analgesia. The QLB, first described by Blanco (2007) , offers extended analgesia due to its paravertebral spread, thereby addressing both somatic and visceral pain . In contrast, TFPB targets the transversalis fascia to block the T12 and L1 nerves, effectively reducing postoperative pain following cesarean delivery . Although both QLB and TFPB have been shown to provide superior analgesia compared to TAP blocks , limited data exist regarding their comparative ease of performance and procedural efficiency.
Given that the analgesic efficacy of TFPB and QLB appears comparable, it is essential to evaluate additional factors such as the time required to perform the block and the technical ease of the procedure. These factors are particularly critical in high-volume obstetric settings, where efficiency can significantly impact clinical workflow . Therefore, this study aims to compare TFPB and QLB not only in terms of analgesic efficacy but also regarding ease of performance and execution time, to determine which technique may be preferable for post-cesarean analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomized into three equal groups (n = 36 per group) to receive either Transversus Abdominis Plane Block (TAPB, control), Transversalis Fascia Plane Block (TFPB), or Quadratus Lumborum Block (QLB). A computer-generated randomization sequence was used, and group allocations were concealed in sealed opaque envelopes, which were opened only after enrollment. Although the anesthesiologist performing the block knew the group allocation, patients and outcome assessors were blinded to minimize bias.
| Arm | Type | Receives |
|---|---|---|
| TAP Block | Active comparator | Procedure: TAP Block:TAP Block: A linear high-frequency probe (6-13 MHz) was placed transversely along the midaxillary line to visualize the external oblique, internal oblique, and transversus abdominis muscles. Using an in-plane approach, a 21G SonoPlex, STIM (PAJUNK, Germany), was advanced, and after hydro-dissection with 1-2 mL saline, 20 mL of 0.25% bupivacaine (Marcaine, AstraZeneca, Sweden) was injected into the plane between the internal oblique and transversus abdominis muscles. |
| TFP Block | Experimental | Procedure: TFP Block:TFP Block: With a linear probe, the transversalis fascia was identified between the internal oblique and transversus abdominis muscles. An in-plane technique was used to insert a 21G needle, and following confirmation of correct placement with hydro-dissection, 20 mL of 0.25% bupivacaine was administered bilaterally. |
| QLB: | Experimental | Procedure: QLB:QLB: A low-frequency curvilinear probe (2-5 MHz) was used to identify the quadratus lumborum muscle and adjacent structures. The needle was advanced in-plane until it reached the targeted region adjacent to the quadratus lumborum, where after hydro-dissection, 20 mL of 0.25% bupivacaine was injected bilaterally. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women aged 20-40 years scheduled for elective cesarean delivery under spinal anesthesia .
- American Society of Anesthesiologists (ASA) physical status of II
- Body mass index (BMI) of less than 35 kg/m² .
Key exclusion criteria (6 listed)
- History of allergy to local anesthetics.
- Contraindications to regional anesthesia (such as coagulopathy or infection at the injection site).
- Severe systemic diseases (renal, hepatic, or cardiovascular dysfunction).
- weight less than 50 kg (to avoid exceeding safe doses of local anesthetic).
- pregnancy complications like severe preeclampsia, eclampsia, or postpartum hemorrhage.
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 |
|---|---|---|
| TAP Block:TAP Block: A linear high-frequency probe (6-13 MHz) was placed transversely along the midaxillary line to visualize the external oblique, internal oblique, and transversus abdominis muscles. Using an in-plane approach, a 21G SonoPlex, STIM (PAJUNK, Germany), was advanced, and after hydro-dissection with 1-2 mL saline, 20 mL of 0.25% bupivacaine (Marcaine, AstraZeneca, Sweden) was injected into the plane between the internal oblique and transversus abdominis muscles. | Procedure or surgery | TAP Block |
| TFP Block:TFP Block: With a linear probe, the transversalis fascia was identified between the internal oblique and transversus abdominis muscles. An in-plane technique was used to insert a 21G needle, and following confirmation of correct placement with hydro-dissection, 20 mL of 0.25% bupivacaine was administered bilaterally. | Procedure or surgery | TFP Block |
| QLB:QLB: A low-frequency curvilinear probe (2-5 MHz) was used to identify the quadratus lumborum muscle and adjacent structures. The needle was advanced in-plane until it reached the targeted region adjacent to the quadratus lumborum, where after hydro-dissection, 20 mL of 0.25% bupivacaine was injected bilaterally. | Procedure or surgery | QLB: |
Primary outcome
postoperative pain by Numeric Pain Rating Scale
Time frame: 6 ,12 and 24 hours
The primary outcome, postoperative pain, was assessed using the Numeric Pain Rating Scale (NRS) at predefined intervals: 6, 12, and 24 hours postoperatively. Pain scores were documented by trained nursing staff blinded to the intervention. Opioid administration was standardized-patients received nalbuphine in 2 mg increments as needed (NRS more than 4), with a maximum dose of 10 mg in 24 hours.Minimum score 0 (no pain) and maximum 10 (severe pain). The lower the number the more free pain and the more high scale the more pain present.
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 13 Mar 2025.
- Results publication: PubMed 37865903Ferguson JE, Tubog TD, Johnson W, Evans H, Furstein J. Quadratus Lumborum Block and Transversus Abdominis Plane Block in Non-emergency Cesarean Delivery: A Systematic Review and Meta-analysis. J Perianesth Nurs. 2024 Apr;39(2):226-234. doi: 10.1016/j.jopan.2023.07.017. Epub 2023 Oct 20.
- Results publication: PubMed 27755488Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
- Results publication: PubMed 36447913Benedicta R, Jain MK, Dixit N, Shivappagoudar VM. The Efficacy of Ultrasound-guided Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Lower-Segment Cesarean Section with Low-Dose Bupivacaine: A Randomized Controlled Trial. Anesth Essays Res. 2022 Apr-Jun;16(2):203-207. doi: 10.4103/aer.aer_84_22. Epub 2022 Sep 6.
- https://pubmed.ncbi.nlm.nih.gov/36447913/Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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 TAP Block:, TFP Block: and QLB: in people with Regional Anesthesia Block, run by Aswan 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 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 13 Mar 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?
postoperative pain by Numeric Pain Rating Scale (time frame: 6 ,12 and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06874569, which also lists 3 linked publications.
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 13 Mar 2025.