Comparison of Postoperative Analgesia Methods in Elective Cesarean Section Surgeries

Postoperative Pain Clinical Trial

Official title:

Comparison of Transversalis Fascia Plane Block and Surgical Site Local Anesthetic Infiltration in Elective Cesarean Section Surgeries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425718
• Other study ID #: MarmaraClinical
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Postoperative Pain

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