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Completed

NCT Number: NCT05758233

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

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.

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Key information

Conditions

Anesthesia; Sexual Agnosia Analgesia Behavior Coitus Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Sexual Behavior Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Basaksehir, 3268, Turkey (Türkiye)

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Patients undergoing transversalis fascia plane block

Procedure

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.

Patients undergoing transversus abdominis plane block

Procedure

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.

Primary outcomes

  1. time of first analgesic need

    Time frame: 24 hours postoperatively

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

Secondary outcomes

  1. visuel analog scale

    Time frame: 24 hours postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Comparison of the Effectiveness of Ultrasound-guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block on Postoperative Pain in Caesarean Section : a Prospective Randomized Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 7, 2023
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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