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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05698927
• Other study ID #: MarmaraMedical
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2024
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Erector Spinae Plane Block (bilaterally, via 20ml % 0.5 bupivacain) and Intrathecal Morphine (100 mcg)
Comparison of the postoperative opioid consumptions between Erector Spinae Plane Block (bilaterally, via 20ml % 0.5 bupivacain) and Intrathecal Morphine (100 mcg)

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul
Turkey	Marmara University School of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.
Primary	Opioid Consumption	Comparing opioid (tramadol) consumption via intravenous Patient Controlled Analgesia (PCA) device	24 hours
Secondary	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
Secondary	Rescue analgesia	when the patient's NRS score = 4, diclofenac 75 mg intramuscular is given	24 hours
Secondary	Side effects of medications	Intravenous and intrathecal opioids can cause nausea-vomiting, itching, respirator depression	24 hours