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Clinical Trials/NCT05698927
NCT05698927CompletedNot Applicable

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

Marmara University4 sites in 2 countries82 target enrollmentStarted: February 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
82
Locations
4
Primary Endpoint
Opioid Consumption

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
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

  • 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

Outcomes

Primary Outcomes

Opioid Consumption

Time Frame: 24 hours

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

Secondary Outcomes

  • Pain Scores(24 hours)
  • Side effects of medications(24 hours)
  • Rescue analgesia(24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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