- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06874569
A Comparing Transversalis Fascia Plane Block and Quadratus Lumborum Block for Post-Cesarean Pain Management: Efficacy, Execution Time, and Practicality
Assistant Professor and the Principle Investigator
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aswan, Egypt, 81528
- Ayman Mohamady Eldemrdash
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:-
- 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 .
Exclusion criteria :-
- 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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 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.
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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.
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Experimental: 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.
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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.
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Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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postoperative pain by Numeric Pain Rating Scale
Time Frame: 6 ,12 and 24 hours
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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.
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6 ,12 and 24 hours
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Blanco 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. Erratum In: Reg Anesth Pain Med. 2018;43:111.
- 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.
- Benedicta 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- regional block post C-section
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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