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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid Use Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Comparison of the postoperative opioid consumptions between Erector Spinae Plane Block (bilaterally, via 20ml % 0.25 bupivacain) and Intrathecal Morphine (100 mcg)

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Comparison of the postoperative opioid consumptions between Erector Spinae Plane Block (bilaterally, via 20ml % 0.25 bupivacain) and Intrathecal Morphine (100 mcg)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No