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

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

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 Overview

• Status: Completed
• Conditions: Postoperative Pain; Opioid Use
• Intervention / Treatment: Procedure: Erector Spinae Plane Block (bilaterally, via 20ml % 0.25 bupivacain) and Intrathecal Morphine (100 mcg)

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Marmara University
  • Istanbul, Turkey
    • Marmara University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Study Population

Patients between 18 and 40 years old, ASA I-II, undergoing elective cesarean section in Marmara University Hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bilateral Erector Spinae Plane Block Group; Intrathecal morphine (100mcg) and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 20 minutes) Comparing postoperative pain and opioid consumption in groups	Procedure: Erector Spinae Plane Block (bilaterally, via 20ml % 0.25 bupivacain) and Intrathecal Morphine (100 mcg); Comparison of the postoperative opioid consumptions between Erector Spinae Plane Block (bilaterally, via 20ml % 0.25 bupivacain) and Intrathecal Morphine (100 mcg)
Active Comparator: Intrathecal Morphine Group; Bilateral Erector Spinae Plane Block (with %0.25 bupivacaine, 20 ml for each side) and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 20 minutes) Comparing postoperative pain and opioid consumption in groups	Procedure: Erector Spinae Plane Block (bilaterally, via 20ml % 0.25 bupivacain) and Intrathecal Morphine (100 mcg); Comparison of the postoperative opioid consumptions between Erector Spinae Plane Block (bilaterally, via 20ml % 0.25 bupivacain) and Intrathecal Morphine (100 mcg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Comparing opioid (tramadol) consumption via intravenous Patient Controlled Analgesia (PCA) device	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	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'	24 hours
Rescue analgesia	when the patient's NRS score ≥ 4, diclofenac 75 mg intramuscular is given	24 hours
Side effects of medications	Intravenous and intrathecal opioids can cause nausea-vomiting, itching, respirator depression	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction	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'	24 hours
Apgar scores of newborns	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.	1st and 5th minute after the delivery.

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Chair: Beliz Bilgili, Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: postoperative pain; opioid consumption; erector spinae plane block; intrathecal morphine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: MarmaraMedical

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No