Comparison of Postoperative Analgesia Methods in Elective Cesarean Section Surgeries

NCT06425718 | Completed

• 1 other identifier: MarmaraClinical
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use; Postoperative Pain

Keywords

opioid use; postoperative pain; transversalis plane block

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (1)

• Postoperative pain assessment with Numeric Rating Scale (NRS)

  24 hours

Study Arms (2)

Transversalis Fascia Plane Block

ACTIVE COMPARATOR

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: 10 minutes)

Procedure: Postoperative Pain Management Technique

Surgical Site Local Anesthetic Infiltration

ACTIVE COMPARATOR

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: 10 minutes)

Procedure: Postoperative Pain Management Technique

Interventions

Postoperative Pain Management Technique PROCEDURE

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

Surgical Site Local Anesthetic Infiltration; Transversalis Fascia Plane Block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old
• ASA II-III patients undergoing elective cesarean section

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Education and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Beliz Bilgili

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 22, 2024
• Study Start: May 15, 2024
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

TU (1)