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Active, not recruiting Observational

The Effect of Intrathecal Morphine and Erector Spina Plan Block on Serum Cytokine Levels and Chronic Pain in Caesarean Section Surgery

NCT06684015 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2024-03-01
Last updated
2024-11-12

Condition(s) studied

Cesarean DeliveryPostoperative PainCytokine LevelsChronic Pain, Postoperative

Investigational drug(s) / intervention(s)

İNTRATECHAL MORPHİNE GROUPErector Spinae Plane Block

İNTRATECHAL MORPHİNE GROUP: Addition of intrathecal morphine as an adjuvant to local anesthesia in routine spinal anesthesia application and multimodal analgesia applications

Erector Spinae Plane Block: Application of erector spinae plane block and multimodal analgesia applications at the end of the operation after routine spinal anesthesia application

Study summary

Working Title The Effect of Intrathecal Morphine and Erector Spina Plan Block on Serum Cytokine Levels and Chronic Pain in Caesarean Section Surgery

Study Description This study aims to evaluate the effects of intrathecal morphine added as an adjuvant to local anesthesia during spinal anesthesia and the erector spinae plane block applied at the end of cesarean surgery on postoperative serum cytokine levels, pain intensity, need for rescue analgesia, hospital anxiety and depression levels, quality of obstetric recovery, and the development of chronic postoperative pain.

Study Type Study Design: Observational Model: Two parallel groups Time Perspective: Prospective

Interventions Intervention Type: Drug and Block Procedure Details: In patients included in the study, intrathecal morphine is administered as an adjuvant to local anesthesia during spinal anesthesia first group. At the end of surgery, an erector spinae plane block is performed other group.

Primary Outcome Measures Serum Cytokine Levels Time Frame: 0., 6. and 24. Hours Assessment Method: Serum biochemical analyses

Pain Intensity and Need for Rescue Analgesia Time Frame: 2., 4., 6., 12. and 24. hours, assessed using the Numeric Rating Scale(NRS)

Hospital Anxiety and Depression Levels Time Frame: Preoperative and at 24 hours postoperatively Assessment Method: Hospital Anxiety and Depression Scale (HADS)

Quality of Obstetric Recovery Score Time Frame: At 24 hours postoperatively

Chronic Postoperative Pain Development Time Frame: Evaluated at 4 months postoperatively Assessment Method: Short Form McGill Pain Questionnaire-2

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 18 years and older * ASA II * Elective surgery * Spinal anesthesia * To accept participation in the study and regional anesthesia applications Exclusion Criteria: * Under 18 years old * BMI (body mass index) \>35 kilograms/meter2 (kg/m2) * ASA III and above * Multiple pregnancy * Previous abdominal surgery * History of malignancy * Contraindication for regional anesthesia * Known history of allergy to the drugs to be used * Presence of chronic pain (migraine, fibromyalgia, etc.) * History of substance abuse * Regular use of painkillers (simple analgesics, gabapentinoids, opioids)

Primary outcome measure(s)

  • postoperative serum cytokine — 24 hours
    We aimed to investigate the effects of intrathecal morphine administered as adjuvant in spiral anesthesia and erector spina plan block performed at the end of the operation on postoperative serum cytokine (Interleukin-6, Tumor Necrosis Factor-alpha, Interleukin-10) levels. In order to evaluate the basal serum cytokine levels from each patient, 5 milliliters (ml) of venous blood will be taken before the operation (after monitoring-before spinal anesthesia). In order to evaluate the changes in serum cytokine levels after the operation, the moment when the first blood sample is taken will be considered as the beginning; 5 ml of venous blood will be taken at the 6th and 24th hours. Although many time periods are stated in the literature for the control of cytokine levels (6, 11, 12), the hours planned for the control blood samples were determined as the 6th and 24th hours, considering the start and end times of the effects of the methods used in the study arms.
  • Chronic pain — 4 months
    We aimed to investigate the effects of intrathecal morphine administered as adjuvant in spiral anesthesia and erector spina plan block performed at the end of the operation on chronic pain in patients undergoing cesarean section surgery. The assessment will be made with the McGill Short Form Pain Questionnaire-2. The questionnaire consists of 22 items. Each question is evaluated with a Numeric Rating Scale. A low score is associated with less pain, while a high score is associated with more pain.

Trial sites (1)

FacilityCityRegionStatus
Ankara University Faculty of Medicine Ankara Altındağ
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06684015 on ClinicalTrials.gov ↗ ← All trials in Turkey