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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05117307
Other study ID # TFP vs ESP on C/S
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date June 30, 2022

Study information

Verified date December 2021
Source Erzurum Regional Training & Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cesarean section is one of the most common major surgical procedures performed worldwide,, Post-cesarean analgesia should provide adequate pain control while allowing the mother to remain active to meet the needs of the baby. Insufficient analgesia after cesarean section may be associated with acute postoperative pain, chronic pain, higher opioid consumption, delayed functional capacity, and postpartum depression. Techniques such as neuraxial techniques, oral and intravenous agents, wound infiltration, and behavioral therapy can be used in the treatment of post-cesarean pain pain. In addition, Transversus abdominis plane block (TAP), Quadratus Lumborum block (QLB), Erector Spina block (ESP), Transversalis Fascia plane block (TFP) are used safely under ultrasound guidance. In this study, it was aimed primarily to examine the effects of TFP and ESP blocks on pain scores, and secondarily to evaluate analgesic consumption.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 30, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Between 18-50 years - Cesarean Section Exclusion Criteria: - Cesarean Section under general anesthesia - emergency cases - those with a body mass index greater than 35 kg/m2 - coagulopathy - local infection

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine 0.25% Injectable Solution
Ultrasound-guided block with 20 ml %0.25 bupivacaine, per side

Locations

Country Name City State
Turkey Erzurum Regional Training and Research Hospital Erzurum Yakutiye

Sponsors (1)

Lead Sponsor Collaborator
Erzurum Regional Training & Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid Consumption Opioid consumption postroperative period Postoperative first 24 hours
Secondary Visual Analog Pain Score Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) Postoperative first 24 hours
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