A Comparing Transversalis Fascia Plane Block and Quadratus Lumborum Block for Post-Cesarean Pain Management: Efficacy, Execution Time, and Practicality

NCT06874569 | Completed DMC

• 1 other identifier: regional block post C-section
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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. This study evaluates whether TFPB or QLB is preferable when their analgesic efficacy is nearly equal, focusing on ease of performance and execution time.

Conditions

Regional Anesthesia Block

Outcome Measures

Primary Outcomes (1)

• 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.

  6 ,12 and 24 hours

Study Arms (3)

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.

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.

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.

Procedure: QLB:

Interventions

TAP Block: PROCEDURE

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.

TAP Block

TFP Block: PROCEDURE

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.

TFP Block

QLB: PROCEDURE

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.

QLB:

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University: lead
• Aswan University Hospital: collaborator

Study Sites (1)

Ayman Mohamady Eldemrdash

Aswān, 81528, Egypt

Location

Related Publications (3)

• 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.

  PMID: 37865903 BACKGROUND

• 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.

  PMID: 27755488 BACKGROUND

• 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.

  PMID: 36447913 BACKGROUND

Related Links

• https://pubmed.ncbi.nlm.nih.gov/36447913/

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: March 13, 2025
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 15, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)