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

NCT06221280 | Enrolling By Invitation

• 1 other identifier: 2023/10-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Nerve block, cesarean, postpartum depression

Outcome Measures

Primary Outcomes (1)

• Pain (VAS score)

  Evaluation of the postoperative analgesic effectiveness of erector spinae and transversus abdominis plane blocks after cesarean section

  12 months

Secondary Outcomes (1)

• Postpartum depression (Edinnburg Depression Scale)

  12 months

Study Arms (2)

Group E

ACTIVE COMPARATOR

Patients who underwent erector spinae plane block

Procedure: Nerve block

Group T

ACTIVE COMPARATOR

Patients who underwent transversus abdominis plane block

Procedure: Nerve block

Interventions

Nerve block 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 E; Group T

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Application in cesarean section cases
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a good mental status,
• Those aged ≥18 years,
• Term pregnant (gestational age ≥ 36 weeks),
• American Society of Anesthesiologists class II-III,
• Patients who underwent cesarean section with spinal anesthesia will be included.

You may not qualify if:

• Having labor at term or obstetric emergency,
• Having a twin pregnancy,
• Having a diagnosed psychiatric disorder/using psychiatric medication,
• Those who are allergic to local anesthetics and/or drugs used in the study,
• The patient-controlled anesthesia device is out of use for any reason within the first 24 hours postoperatively,
• Having peripheral neuropathy or neuromuscular disease,
• Patients using anticoagulant drugs that will prevent regional anesthesia will be excluded from the study.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

KahramanmarasSIU

Kahramanmaraş, Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Depression, Postpartum

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: November 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: October 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-07

Locations

TU (1)