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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06425718
Other study ID # MarmaraClinical
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2024
Est. completion date June 30, 2024

Study information

Verified date May 2024
Source Marmara University
Contact Beliz Bilgili
Phone +905362187927
Email belizbilgili@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, multimodal analgesia strategies with peripheral nerve blocks are preffered with greater safety in elective Cesarean section surgeries. The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis fascia plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia.


Description:

After Cesarean sections, several factors play a role in the formation of postoperative pain, including parietal stimulation originating from the surgical incision, visceral stimulation originating from the peritoneum, and manipulation of intra-abdominal structures. To enhance patients' rehabilitation during the postoperative period, promote lactation and infant care, and reduce hospital stays, the most appropriate postoperative analgesia method should be selected. Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, regional anesthesia techniques are preferred with greater safety in elective Cesarean section surgeries. In the postoperative period, multimodal analgesia strategies can be used for pain control, and one of these strategies is postoperative peripheral nerve blocks. Ultrasound guided transversalis fascia plane block is one of the preferred methods for postoperative analgesia in cesarean section patients. The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 42
Est. completion date June 30, 2024
Est. primary completion date June 15, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients over 18 years old - ASA II-III patients undergoing elective cesarean section Exclusion Criteria: - ASA IV patients - Patients with known neurologic or psychiatric disorders - Patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease - Patients with alcohol or drug addiction - Mentally disabled patients - Patients with BMI>30 - Patients who develop massive bleeding or coagulopathy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Postoperative pain management technique
Patients who will undergo cesarean section under spinal anesthesia will be included. Comparing postoperative pain and opioid consumption in groups

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device Intravenous patient-controlled analgesia (PCA) is a system of opioid delivery that consists of an infusion pump interfaced with a timing device. Intravenous tramadol consumption will be recorded via PCA device, then it will be documented in mg/kg units. 48 hours
Secondary Postoperative pain assessment with Numeric Rating Scale (NRS) In a Numerical Rating Scale (NRS), patients are asked to choose from 1 to 10. 1: no pain 10: worst pain experienced 48 hours
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