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CompletedNCT04172727Updated Nov 21, 2019

Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Section

A Phase 4 interventional study of Bupivacaine Hcl 0.25% Inj and saline 0.9% in Caesarean Section and Pain, Acute, sponsored by Ataturk University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-21.

Sponsored by Ataturk University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2019, registered Nov 2019).
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study summary

Postoperative pain management is critical for the fulfillment of the maternal duties. The transversalis fascia plane (TFP) block provides adequate postoperative analgesia in the T12 and L1 dermatomes. The aim of this study was to investigate the effect of the TFP block on postoperative opioid consumption and pain scores in patients undergoing cesarean section (CS) under spinal anesthesia.

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Conditions studied

  • Caesarean Section
  • Pain, Acute

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03

In context

Acute Pain

876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.

This study's enrollment of 60 is below the median of 90 across 732 interventional studies indexed under Acute Pain.

Browse Acute Pain studies →

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • aged between 18 and 45
  • American Society of Anesthesiologists (ASA) physical score I or II

Exclusion criteria

Exclusion Criteria:

  • Patients who received general anesthesia
  • hypersensitivity to the agents to be used
  • body mass index (BMI) greater than 35 kg/m2
  • coagulopathy
  • local infections
  • opioid addiction
  • pregnancy-related hypertension or diabetes mellitus
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    ultrasound guided transversalis fascia plane block

    20 mL of 0.25% bupivacaine

    Drug: Bupivacaine Hcl 0.25% Inj

  • Placebo comparator
    ultrasound guided sham block

    20 mL of saline

    Drug: saline 0.9%

Interventions

  • DrugBupivacaine Hcl 0.25% Inj

    ultrasound-guided bilateral TFP block with 20 mL of 0.25% bupivacaine

  • Drugsaline 0.9%

    ultrasound-guided bilateral TFP block with 20 mL of saline 0.9%

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What researchers measure

Primary outcomes

  1. opioid consumption

    morphine consumption first 24hour

    Time frame: Postoperative first 24hour

Secondary outcomes

  1. pain scores

    Visual Analogue Scale (0-10)

    Time frame: postoperative 0-24 hours

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Study locations

1 site
  • Ali Ahıskalıoğlu
    Erzurum, 25100, Turkey
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References and documents

Publications

  • Serifsoy TE, Tulgar S, Selvi O, Senturk O, Ilter E, Peker BH, Ozer Z. Evaluation of ultrasound-guided transversalis fascia plane block for postoperative analgesia in cesarean section: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2020 Feb;59:56-60. doi: 10.1016/j.jclinane.2019.06.025. Epub 2019 Jun 27. PubMed 31255890 ↗
  • Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. No abstract available. PubMed 19495909 ↗
  • Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222. PubMed 32412986 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04172727
Lead sponsor
Ataturk University
Responsible party
Ali Ahiskalioglu (Principal Investigator, Ataturk University) — Principal investigator
First posted
Nov 21, 2019
Start date
Jan 1, 2019
Primary completion
May 1, 2019
Completion
Jun 1, 2019
Last update
Nov 21, 2019

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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