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

Not Applicable

Completed

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

• Registration Number: NCT05698927
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-26
• Study Start: 2023-02-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-25
• Last Update Posted: 2024-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Opioid Consumption	24 hours	Comparing opioid (tramadol) consumption via intravenous Patient Controlled Analgesia (PCA) device

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Marmara University; 🇹🇷 Istanbul, Turkey

Marmara University School of Medicine; 🇹🇷 Istanbul, Turkey