Comparing Postoperative Analgesic Effects of Intrathecal Morphine and Bilateral Erector Spina Plane Block in Elective Cesarean Sections

Sponsor
Marmara University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05698927
Collaborator
(none)
76
2
10
38
3.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    76 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparing of The Postoperative Analgesic Effects of Intrathecal Morphine and Ultrasound-guided Bilateral Erector Spinae Plane Block in Elective Cesarean Section Operations
    Actual Study Start Date :
    Nov 1, 2022
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Intrathecal Morphine Group

    Prosedure/Surgery: Regional block and Intrathecal Morphine Comparison Comparing postoperative pain and opioid consumption in groups

    Bilateral Erector Spinae Plane Block Group

    Prosedure/Surgery: Regional block and Intrathecal Morphine Comparison Comparing postoperative pain and opioid consumption in groups

    Outcome Measures

    Primary Outcome Measures

    1. Pain Scores [24 hours]

      Comparing pain scores with Numeric Rating Scale (NRS)

    2. Opioid Consumption [24 hours]

      Comparing opioid consumption via Patient Controlled Analgesia (PCA) device

    Secondary Outcome Measures

    1. Participant satisfaction [24 hours]

      Comparing pain with numeric rating scale (NRS)

    2. Apgar scores of newborns [1st and 5th minute after the delivery]

      APGAR (Activity, Pulse, Grimace, Appearance, Respiration) scores may be effected by intrathecal morphine

    3. Side effects of medications [24 hours]

      ─░ntravenous and intrathecal opioid can cause nausea-vomiting, respirator depression, itching

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients between 18 and 40 years old, ASA (American Society of Anesthesiologists) score I-II, undergoing elective cesarean section
    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marmara University School of Medicine Istanbul Turkey
    2 Marmara University Istanbul Turkey

    Sponsors and Collaborators

    • Marmara University

    Investigators

    • Study Chair: Beliz Bilgili, Marmara University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marmara University
    ClinicalTrials.gov Identifier:
    NCT05698927
    Other Study ID Numbers:
    • MarmaraMedical
    First Posted:
    Jan 26, 2023
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Marmara University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2023