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The Effect of Bilateral Erector Spina Plane Block on Postoperative Analgesia in Cesarean Section Under SpinalAnaesthesia

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Spinal anesthesia + bilateral erector spine plane block
Spinal anesthesia
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring Erector spina plane block, postoperative pain, obstetric analgesia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: between 18-45 years, pregnants delivered by CS from May 2020 to June 2021 Exclusion Criteria: age under 18 years, over 45 years, body mass index (BMI) over 35 kg/m2, ASA status over III, multiple pregnancy, preeclampsia, bleeding diathesis, opioid use and allergy to drugs to be used in the study

Sites / Locations

  • Bengi Şafak

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group ESPB

Group SA

Arm Description

Spinal anesthesia + bilateral ESPB (total of 40 ml, %0.5 bupivacaine)

Only spinal anesthesia

Outcomes

Primary Outcome Measures

Postoperative pain
VAS scores at 2, 4, 6, 12 and 24th hours. (VAS is an 11 point numeric scale ranges from 0 to 10. )

Secondary Outcome Measures

Postoperative analgesic drug consumption
Diclofenac consumption in the first 24 hours was measured.
Need for rescue analgesic
The number of patients who required rescue analgesic in the first 24 hours and paracetamol consumption were recorded.
Number of patients with postoperative nausea-vomiting and need of antiemetic usage
Number of patients with postoperative nausea-vomiting and need of antiemetic usage were recorded.
Patients' satisfaction
At the postoperative 2, 4, 6, 12 and 24th hours patients' satisfaction was assessed using a descriptive verbal scale (11 point scale from 0 to 10. 0: not satisfied, 10: very satisfied).
First analgesic using time, first mobilization time, hospitalization time
Postoperative first analgesic using time, first mobilization time and hospitalization time were recorded.
ESPB spread level
The range of sensory block level in ESPB group was evaluated as dermatomal after the effect of spinal anesthesia passed, at 4-6th hours with pin-prick test.

Full Information

First Posted
January 13, 2023
Last Updated
January 23, 2023
Sponsor
Ankara University
Collaborators
Ahmet Onat Bermede, Süheyla Karadağ Erkoç, Volkan Baytaş, Bulut Varlı, Hanife Asuman Uysalel
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1. Study Identification

Unique Protocol Identification Number
NCT05695625
Brief Title
The Effect of Bilateral Erector Spina Plane Block on Postoperative Analgesia in Cesarean Section Under SpinalAnaesthesia
Official Title
The Effect of Bilateral Erector Spina Plane Block on Postoperative Analgesia in Cesarean Section Under Spinal Anaesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
June 6, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
Collaborators
Ahmet Onat Bermede, Süheyla Karadağ Erkoç, Volkan Baytaş, Bulut Varlı, Hanife Asuman Uysalel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute pain after cesarean section (SC) can be variable. Untreated pain can affect patients' life quality. Currently regional nerve blocks are frequently used as a part of multimodal analgesia. Erector spina plane block (ESPB), a recently defined interfacial plane block, provides multisegmental analgesia by spreading to both ventral and dorsal branches of the spinal nerve roots in the cranio-caudal plane with a single injection. The aim of this study is to evaluate the effects of ESPB on postoperative pain, analgesic use and patient satisfaction in patients delivered by CS under spinal anesthesia.
Detailed Description
Cesarean section (CS) is one of the most common surgical procedures in the world. Acute pain intensity after cesarean section can be variable, making difficult to predict pain severity. Untreated pain can affect patients' life quality. Currently regional nerve blocks are frequently used as a part of multimodal analgesia. Erector spina plane block (ESPB) is a recently defined interfascial plane block. As a result of ultrasound (USG) guided local anesthetic drug injection into the fascial plane between erector spina muscle and vertebral transverse process, multisegmental analgesia provided by spreading to the both ventral and dorsal branches of the spinal nerve roots in cranio-caudal plane with a single injection. The primary aim of this study was to evaluate the effects of bilateral ESPB on postoperative pain, using the visual analog scale (VAS) in patients delivered by CS under spinal anesthesia. The secondary aims of the study are to evaluate the effects of ESPB on analgesic drug use and patient satisfaction in the postoperative period. 116 pregnants, aged between 18-45 years, delivered by CS from May 2020 to June 2021 included the prospective, randomised, single centre study. Exclusion criteria were age under 18 years, over 45 years, body mass index (BMI) over 35 kg/m2, ASA status over III, multiple pregnancy, preeclampsia, bleeding diathesis, opioid use and allergy to drugs to be used in the study. Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace with 26G quincke spinal needle in the sitting position. At the end of the surgery, in ESPB group, patients were given a sitting position with the help of 2 people for USG-guided ESPB. The high-frequency linear USG probe was placed in the midline at T12 level, after the spinous process visualized, the transverse process was visualized by moving probe 3-4cm laterally. After confirming the location of the needle tip with 1-2ml hydrodissection, 10 ml bupivacaine + 10 ml salin was applied both right and left sides. At the postoperative 2, 4, 6, 12 and 24th hours, patients' rest, cough, movement, low back and headache VAS values, analgesic drug use, first analgesic use time and satisfaction were evaluated. ESPB spread level was evaluated with pin-prick at the 4-6th hours. The SPSS 11.5 program was used for statistical analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Erector spina plane block, postoperative pain, obstetric analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group ESPB
Arm Type
Active Comparator
Arm Description
Spinal anesthesia + bilateral ESPB (total of 40 ml, %0.5 bupivacaine)
Arm Title
Group SA
Arm Type
Active Comparator
Arm Description
Only spinal anesthesia
Intervention Type
Other
Intervention Name(s)
Spinal anesthesia + bilateral erector spine plane block
Intervention Description
Intraoperative period: Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace in the sitting position. At the end of the surgery, patients were given a sitting position with the help of 2 people for USG-guided ESPB. The high-frequency linear USG probe was placed in the midline at T12 level, after the spinous process visualized, the transverse process was visualized by moving probe 3-4cm laterally. After confirming the location of the needle tip with 1-2ml hydrodissection, 10 ml bupivacaine + 10 ml salin was applied both right and left sides. Postoperative period: If patients' VAS value >4, 75mg diclofenac intramuscular was administered. After 30 mins if patients' VAS values >4, 1000mg paracetamol intravenously was administered.
Intervention Type
Other
Intervention Name(s)
Spinal anesthesia
Intervention Description
Intraoperative period: Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace in the sitting position. Postoperative period: If patients' VAS value >4, 75mg diclofenac intramuscular was administered. After 30 mins if patients' VAS values >4, 1000mg paracetamol intravenously was administered.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
VAS scores at 2, 4, 6, 12 and 24th hours. (VAS is an 11 point numeric scale ranges from 0 to 10. )
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative analgesic drug consumption
Description
Diclofenac consumption in the first 24 hours was measured.
Time Frame
24 hours
Title
Need for rescue analgesic
Description
The number of patients who required rescue analgesic in the first 24 hours and paracetamol consumption were recorded.
Time Frame
24 hours
Title
Number of patients with postoperative nausea-vomiting and need of antiemetic usage
Description
Number of patients with postoperative nausea-vomiting and need of antiemetic usage were recorded.
Time Frame
24 hours
Title
Patients' satisfaction
Description
At the postoperative 2, 4, 6, 12 and 24th hours patients' satisfaction was assessed using a descriptive verbal scale (11 point scale from 0 to 10. 0: not satisfied, 10: very satisfied).
Time Frame
24 hours
Title
First analgesic using time, first mobilization time, hospitalization time
Description
Postoperative first analgesic using time, first mobilization time and hospitalization time were recorded.
Time Frame
Postoperative 4 days on an average
Title
ESPB spread level
Description
The range of sensory block level in ESPB group was evaluated as dermatomal after the effect of spinal anesthesia passed, at 4-6th hours with pin-prick test.
Time Frame
4-6th hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: between 18-45 years, pregnants delivered by CS from May 2020 to June 2021 Exclusion Criteria: age under 18 years, over 45 years, body mass index (BMI) over 35 kg/m2, ASA status over III, multiple pregnancy, preeclampsia, bleeding diathesis, opioid use and allergy to drugs to be used in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bengi Şafak
Organizational Affiliation
Ankara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bengi Şafak
City
Ankara
ZIP/Postal Code
06230
Country
Turkey

12. IPD Sharing Statement

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The Effect of Bilateral Erector Spina Plane Block on Postoperative Analgesia in Cesarean Section Under SpinalAnaesthesia

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