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NCT Number: NCT05698927

Analgesic Effects of Intrathecal Morphine and Bilateral Erector Spina Plane Block in Elective Cesarean Section

Cesarean section cause severe pain due to surgical incision, abdominal wall retraction and visceral organ movements. Cesarean section can be performed with general anesthesia, spinal anesthesia, epidural anesthesia and combined spinal epidural anesthesia methods.

Because of the possibility of aspiration pneumonia in pregnant women are under general anesthesia, the awareness of anesthesia in the mother during the operation due to insufficient anesthesia, unsuccessful intubation, respiratory complications in the mother and newborn and low APGAR scores, regional anesthesia is superior to general anesthesia in elective cesarean section operations.

Spinal anesthesia, abdominal wall blocks such as erector spinae plane block, parenteral and intrathecal opioids may be used for postoperative analgesia in cesarean section operations.

Intrathecal morphine can cause postoperative nausea-vomiting, itching, respiratory depression. Erector spina plane block can provide effective pain control and reduce opioid consumption.

The primary implication of this study is to compare postoperative pain scores and opioid consumption on elective cesarean section patients under spinal anesthesia with intrathecal morphine or erector spina block in addition to spinal anesthesia.

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Key information

Conditions

Opioid Use Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University, Istanbul, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between 18 and 40 years old, ASA (American Society of Anesthesiologists) score I-II, undergoing elective cesarean section

Exclusion criteria

  • Emergency cesarean section
  • The patients with major hepatic, cardiovascular or renal disease
  • The patients for whom spinal anesthesia is contraindicated
  • The patients who is allergic to any drugs that we use for this study
  • Patients who declined to participate in the study

Treatment and study plan

Erector Spinae Plane Block (bilaterally, via 20ml % 0.25 bupivacain) and Intrathecal Morphine (100 mcg)

Procedure

Comparison of the postoperative opioid consumptions between Erector Spinae Plane Block (bilaterally, via 20ml % 0.25 bupivacain) and Intrathecal Morphine (100 mcg)

Primary outcomes

  1. Opioid Consumption

    Time frame: 24 hours

    Comparing opioid (tramadol) consumption via intravenous Patient Controlled Analgesia (PCA) device

Secondary outcomes

  1. Pain Scores

    Time frame: 24 hours

    In a Numerical Rating Scale (NRS), patients are asked to choose the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas ten represents 'the worst pain ever possible'

  2. Rescue analgesia

    Time frame: 24 hours

    when the patient's NRS score ≥ 4, diclofenac 75 mg intramuscular is given

  3. Side effects of medications

    Time frame: 24 hours

    Intravenous and intrathecal opioids can cause nausea-vomiting, itching, respirator depression

Other outcomes

  1. Participant satisfaction

    Time frame: 24 hours

    Comparing pain with numeric rating scale (NRS) In a Numerical Rating Scale (NRS), patients are asked to choose the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas ten represents 'the worst pain ever possible'

  2. Apgar scores of newborns

    Time frame: 1st and 5th minute after the delivery.

    APGAR (Activity, Pulse, Grimace, Appearance, Respiration) score is a measure of the physical condition of a newborn infant. It is obtained by adding points (2, 1, or 0) for heart rate, respiratory effort, muscle tone, response to stimulation, and skin coloration; a score of 10 represents the best possible condition. It may be effected by intravenous or intrathecal opioids that is given to mother.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Can Erector Spinae Plane Block Replace Intrathecal Morphine in Cesarean Section? a Prospective Randomized Controlled Study on Opioid Consumption

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2023
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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