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CompletedNCT05758233Updated Jul 17, 2023

The Effect of Peripheral Nerve Blocks on Postoperative Analgesia in Elective Cesarean Section

An interventional study of Patients undergoing transversalis fascia plane block and Patients undergoing transversus abdominis plane block in Anesthesia; Sexual and Analgesia, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Completed at 1 site in Turkey. Open to female participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-17.

Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2022, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
Female
01

Study summary

The goal of this prospective randomized study was to compare the efficacy of transversus abdominis plane block and transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean section under spinal anesthesia.

The main question[s] it aims to answer are:

[Is transversalis fascia plane block more effective in postoperative analgesia? ]

[Is there a difference between the duration of postoperative first analgesia requirement? ] Since the pain scores after the block at the end of the operation will be evaluated during the postoperative 24 hours, the participants will be asked to give a value between 0 and 10 in certain time periods.

Read the detailed description

This prospective, randomized trial was conducted at Başakşehir Çam and Sakura City Hospital by the Declaration of Helsinki. After ethics committee approval (decision no: 2022-74, date: 09.03.2022) and written informed consent was obtained from all patients, the trial was conduct-ed according to Consolidated Standards of Reporting Trials (CONSORT) guidelines.A total of 150 patients were divided into two groups: transversal fascia plane block (TFPB group) and Transversus abdominis plane block (TAPB group).VAS values, time to first analgesic requirement, analgesic requirements, nausea \& vomiting and pruritus were evaluated for 24 hours postoperatively (6th hour (T2), 12th hour (T3), 24th hour .

02

Conditions studied

  • Anesthesia; Sexual
  • Analgesia

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Keywords

  • anesthesia recovery period
  • cesarean section
  • obstetric anesthesia
  • spinal anaesthesia
  • postoperative analgesia
03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's enrollment of 150 is above the median of 78 across 1,024 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 118 studies on the registry; 14 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 20-50 years old pregnant woman
  • ASAII-III
  • Patients accepting spinal anesthesia

Exclusion criteria

Exclusion Criteria:

  • Morbid obesity(BMI >40)
  • Patients who are switched to general anesthesia in an unexpected perioperative situation
  • Patients with placental anomaly
  • Patients with bupivacaine allergy
  • Fetal distress situations too urgent to wait for spinal anesthesia and patients who do not want spinal anesthesia
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Grup 1: Transversalis Fascia Plane Block (TFPB)

    Transversalis Fascia Plane Block (TFPB)

    Procedure: Patients undergoing transversalis fascia plane block · Procedure: Patients undergoing transversus abdominis plane block

  • Experimental
    Grup 2: Transversus Abdominis Plane Block (TAPB)

    Transversus Abdominis Plane Block (TAPB)

    Procedure: Patients undergoing transversalis fascia plane block · Procedure: Patients undergoing transversus abdominis plane block

Interventions

  • ProcedurePatients undergoing transversalis fascia plane block

    The investigators applied a transversalis fascia plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.

  • ProcedurePatients undergoing transversus abdominis plane block

    The investigators applied a transversus abdominis plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.

06

What researchers measure

Primary outcomes

  1. time of first analgesic need

    Our primary goal was to meet the initial analgesic requirement times.

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. visuel analog scale

    Our secondary aim was to compare postoperative pain scores. The first 24 hours postoperatively were evaluated.Visual analog scale(VAS) was used to assess postoperative pain.6th, 12th, 24th hour VAS values were recorded For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.

    Time frame: 24 hours postoperatively

07

Study locations

1 site
  • Başakşehir Çam and Sakura City Hospital
    Istanbul, Basaksehir 3268, Turkey
08

References and documents

Publications

  • Ryu C, Choi GJ, Jung YH, Baek CW, Cho CK, Kang H. Postoperative Analgesic Effectiveness of Peripheral Nerve Blocks in Cesarean Delivery: A Systematic Review and Network Meta-Analysis. J Pers Med. 2022 Apr 14;12(4):634. doi: 10.3390/jpm12040634. PubMed 35455750 ↗
  • Mitchell KD, Smith CT, Mechling C, Wessel CB, Orebaugh S, Lim G. A review of peripheral nerve blocks for cesarean delivery analgesia. Reg Anesth Pain Med. 2019 Oct 25:rapm-2019-100752. doi: 10.1136/rapm-2019-100752. Online ahead of print. PubMed 31653797 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05758233
Lead sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Responsible party
Duygu Akyol (Principal Investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital) — Principal investigator
First posted
Mar 7, 2023
Start date
Jan 4, 2022
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022
Last update
Jul 17, 2023

Study contacts

Duygu Akyol, M.D
principal investigator · Başakşehir Çam & Sakura City Hospital

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 Jul 2023. You cannot join it, but the record below documents what was studied.

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