Comparison of Postoperative Analgesia Methods in Elective Cesarean Section Surgeries

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Opioid Use
• Intervention / Treatment: Procedure: Postoperative pain management technique

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beliz Bilgili; Phone Number: +905362187927; Email: belizbilgili@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transversalis Fascia Plane Block; Bilateral Transversalis Fascia Plane Block (with %0.25 bupivacaine, 20 ml for each side) and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 20 minutes)	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
Active Comparator: Surgical Site Local Anesthetic Infiltration; Local anesthetic infiltration will be applied to the surgical incision area with 0.25% 20 ml bupivacaine and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 20 minutes)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Beliz Bilgili, Marmara University

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: postoperative pain; opioid use; transversalis plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: MarmaraClinical

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No