Comparison of Postoperative Analgesia Methods in Elective Cesarean Section Surgeries

NCT ID: NCT06425718

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-15

Study Completion Date

2024-06-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Opioid Use Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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: 10 minutes)

Group Type ACTIVE_COMPARATOR

Postoperative Pain Management Technique

Intervention Type 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

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)

Group Type ACTIVE_COMPARATOR

Postoperative Pain Management Technique

Intervention Type PROCEDURE

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

Interventions

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Postoperative Pain Management Technique

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beliz Bilgili

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

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Marmara University Pendik Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MarmaraClinical

Identifier Type: -

Identifier Source: org_study_id

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