CClinicalTrials.gg
Status unknownNCT05448495Updated Jul 15, 2022

Posterior Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as a Part of Multimodal Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

A Phase 4 interventional study of Posterior TAP block and ESPB in Analgesia, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-15.

Sponsored by Assiut University · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

To compare the analgesic efficacy of posterior TAP block versus ESPB after PCNL surgery. The hypothesis is that posterior TAP block, as a part of multimodal analgesia, will reduce pain and opioid consumption like ESPB

Read the detailed description

Percutaneous nephrolithotomy (PCNL) is currently the gold standard for treatment of patients with large and complex renal calculi because it is less invasive than open surgery. The sources of acute pain after PCNL are visceral pain originating from kidneys and ureters, and somatic pain from the site incision. PCNL is usually done in 10th to 11th intercostal space or in the subcostal area. Complete blockade of unilateral spinal nerves from T10 to L2 can provide sufficient analgesia during PCNL. This can be achieved by several regional techniques such as thoracic paravertebral block, transversus abdominis plane (TAP) block, erector spinae plane block (ESPB).

ESPB is an interfascial block which can provide wide sensory blockade from T2-4 to L1-2 that was first described in 2016. ESPB can be performed by injecting the local anesthetic in the deep interfascial plane of the erector spinae muscle with nearly one dermatome for each 3.4 ml of the injected volume. This allows ESPB to provide both visceral and somatic analgesia. TAP block is a regional injection of a local anesthetic agent between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1). Various technical modifications in TAP block have been described including lateral, posterior, subcostal, and continuous catheter techniques. The posterior approach should be the preferred technique in clinical practice as it provides longer somatic and visceral analgesia that are not offered with the lateral approach.

02

Conditions studied

  • Analgesia

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Keywords

  • Percutaneous nephrolithotomy
  • Erector spinae plane block
  • Transversus abdominis plane block
03

In context

Agnosia

1,189 studies on the registry are indexed under Agnosia; 507 are open to participants now.

This study's planned enrollment of 60 is below the median of 77 across 1,023 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients scheduled for PCNL under general anesthesia
  • ASA status I-II

Exclusion criteria

Exclusion Criteria:

  1. Contraindications to regional block (coagulopathy, infection at the needle insertion site or known allergy to amide local anesthetics)
  2. Patient who has difficulty understanding the study protocol or patient refusal.
  3. Chronic respiratory disease patients.
  4. Diabetic patients.
  5. Body mass index (BMI) > 30 Kg/m2
  6. Routine corticosteroids, pain medication, or anticonvulsant.
  7. Psychiatric diseases.
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Posterior TAP block

    Other: Posterior TAP block

  • Active comparator
    ESPB

    Other: ESPB

Interventions

  • OtherPosterior TAP block

    Using high-frequency linear ultrasound probe, a total volume of 24 ml (20 ml isobaric bupivacaine 0.5% + 2 ml dexmedetomidine \[0.5 mcg\\kg\] + 2ml dexamethasone \[0.1mg\\kg)\] will be injected at the plane between internal oblique and transversus abdominis near the aponeurosis at the posterior axillary line.

    Also known as: Posterior transversus abdominis plane block

  • OtherESPB

    Using high-frequency linear ultrasound probe, a total volume of 24 ml (20 ml isobaric bupivacaine 0.5% + 2 ml dexmedetomidine \[0.5 mcg\\kg\] + 2ml dexamethasone \[0.1mg\\kg)\] will be injected at T9 erector spinae plane

    Also known as: Erector spinae plane block

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What researchers measure

Primary outcomes

  1. The time to first call rescue analgesia

    Time frame: From end of surgery till 24 hours

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05448495
Lead sponsor
Assiut University
Responsible party
FATMA NABIL AHMED MOHAMED (Clinical Professor, Assiut University) — Principal investigator
First posted
Jul 7, 2022
Start date
Jul 13, 2022
Primary completion
Aug 15, 2023 (estimated)
Completion
Sep 15, 2023 (estimated)
Last update
Jul 15, 2022

Study contacts

Fatma Nabil, M.D.
Contact
fatmanabil2012@aun.edu.eg
+201003633992

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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