Effects of Nerve Blocks on Pain After Caesarean Section and Postpartum Depression

NCT ID: NCT06221280

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-10-01

Brief Summary

At the end of your cesarean section surgery, which is started by applying medication to the spinal cavity from your waist, pain medication will be applied between the relevant muscle and its covering from your lower abdomen or back with the help of ultrasonography and a special block needle. Then, a patient-controlled pain device with a serum containing painkillers will be connected to your vascular access, and its use and purpose will be explained to you. You will be asked about your pain condition and the severity score of your pain, if any, at certain hourly intervals. At the end of 24 hours, a pain device will be removed, your satisfaction will be questioned and your complaints, if any, will be recorded. Immediately before surgery and 4-6 days after your surgery. An evaluation survey consisting of 10 questions will be asked to you within a 5-minute period during the weeks, at a time when you are free, and your answers will be recorded.

Conditions

Postoperative Pain; Cesarean Section; Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group E

Patients who underwent erector spinae plane block

Group Type: ACTIVE_COMPARATOR

Nerve block

Intervention Type: PROCEDURE

Group E: While performing the erector spina plan block; Patients are placed in the lateral decubitus position, aseptic conditions are provided, the spinous process in the midline is determined under ultrasonography guidance, and the transverse process is determined 3 cm laterally from the T11 level. 100 mm 22G block needle erector.

Group T: The lumbar petit region will be determined and placed on the lateral abdominal wall at the mid-axillary line, between the iliac crest and the lower costal arch, via a linear probe (12-15 MHz probe). After determining the internal oblique muscle as the thickest muscle and the transversus abdominis muscle as the thinnest muscle, a 100 mm 22 G needle will be placed in the same plane as the USG probe (in-plane or long axis technique). The progress of the needle will be observed on ultrasound along with the facial click sensation. After the second click sensation is felt between the internal oblique and transversalis fascia.

Group T

Patients who underwent transversus abdominis plane block

Group Type: ACTIVE_COMPARATOR

Nerve block

Intervention Type: PROCEDURE

Group E: While performing the erector spina plan block; Patients are placed in the lateral decubitus position, aseptic conditions are provided, the spinous process in the midline is determined under ultrasonography guidance, and the transverse process is determined 3 cm laterally from the T11 level. 100 mm 22G block needle erector.

Group T: The lumbar petit region will be determined and placed on the lateral abdominal wall at the mid-axillary line, between the iliac crest and the lower costal arch, via a linear probe (12-15 MHz probe). After determining the internal oblique muscle as the thickest muscle and the transversus abdominis muscle as the thinnest muscle, a 100 mm 22 G needle will be placed in the same plane as the USG probe (in-plane or long axis technique). The progress of the needle will be observed on ultrasound along with the facial click sensation. After the second click sensation is felt between the internal oblique and transversalis fascia.

Interventions

Nerve block

Group E: While performing the erector spina plan block; Patients are placed in the lateral decubitus position, aseptic conditions are provided, the spinous process in the midline is determined under ultrasonography guidance, and the transverse process is determined 3 cm laterally from the T11 level. 100 mm 22G block needle erector.

Group T: The lumbar petit region will be determined and placed on the lateral abdominal wall at the mid-axillary line, between the iliac crest and the lower costal arch, via a linear probe (12-15 MHz probe). After determining the internal oblique muscle as the thickest muscle and the transversus abdominis muscle as the thinnest muscle, a 100 mm 22 G needle will be placed in the same plane as the USG probe (in-plane or long axis technique). The progress of the needle will be observed on ultrasound along with the facial click sensation. After the second click sensation is felt between the internal oblique and transversalis fascia.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Having a good mental status,

2. Those aged ≥18 years,

3. Term pregnant (gestational age ≥ 36 weeks),

4. American Society of Anesthesiologists class II-III,

5. Patients who underwent cesarean section with spinal anesthesia will be included.

Exclusion Criteria

1. Having labor at term or obstetric emergency,

2. Having a twin pregnancy,

3. Having a diagnosed psychiatric disorder/using psychiatric medication,

4. Those who are allergic to local anesthetics and/or drugs used in the study,

5. The patient-controlled anesthesia device is out of use for any reason within the first 24 hours postoperatively,

6. Having peripheral neuropathy or neuromuscular disease,

7. Patients using anticoagulant drugs that will prevent regional anesthesia will be excluded from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

Feyza Calisir

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KahramanmarasSIU

Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/10-02

Identifier Type: -

Identifier Source: org_study_id