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Clinical Trials in Turkey / NCT06684015
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)

Trial sites (1)

FacilityCityRegionStatus
Ankara University Faculty of Medicine Ankara Altındağ

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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