NCT05698927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

January 16, 2023

Last Update Submit

September 25, 2024

Conditions

Opioid UsePostoperative Pain

Keywords

postoperative painopioid consumptionerector spinae plane blockintrathecal morphine

Outcome Measures

Primary Outcomes (1)

  • Opioid Consumption

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

    24 hours

Secondary Outcomes (3)

  • Pain Scores

    24 hours

  • Rescue analgesia

    24 hours

  • Side effects of medications

    24 hours

Other Outcomes (2)

  • Participant satisfaction

    24 hours

  • Apgar scores of newborns

    1st and 5th minute after the delivery.

Study Arms (2)

Intrathecal Morphine Group

ACTIVE COMPARATOR

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)

Bilateral Erector Spinae Plane Block Group

ACTIVE COMPARATOR

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)

Interventions

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

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between 18 and 40 years old, ASA (American Society of Anesthesiologists) score I-II, undergoing elective cesarean section

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Beliz Bilgili

    Marmara University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2023

First Posted

January 26, 2023

Study Start

February 1, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

September 27, 2024

Record last verified: 2024-09

Locations

TU(2)