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The Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Comparison With Intrathecal Morphine After Elective Cesarean Section

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Erector spinae plane block, morphine, cesarean section, postoperative analgesia, spinal anesthesia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists physical status (ASA) class Ι, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation

Exclusion Criteria:

  • included significant hepatic, renal or cardiovascular diseases, local infection, bleeding disorders, any contraindication to intrathecal anesthesia and parturient had a known allergy to the study drugs.

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

ES Erector Spinae Plane Block

intrathecal morphine ITM

Arm Description

By the end of surgery parturient in the ESPB underwent bilateral ESPB at the level of T9 using a linear ultrasound (US) transducer (Phillips Saronno Italy) the transducer was placed vertically3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine 22-G short bevel needle (spinocan, B.Braun melsungen AG, Germany) was inserted in cranial-caudal direction towards the transvers process using in plane technique until the needle cross all the muscles then interfascial injection of 20ml 0.5% bupivacaine was done after ensuring negative aspiration, the procedure was repeated following the same steps on the other side of the back.

participant in the ITM group intrathecal injection of 10mg of hyperbaric bupivacaine 0.5 % in addition to 100 mcg of preservative-free morphine. Then, the parturient immediately placed in the supine position with 15° left tilt, and an oxygen mask was applied at 2 l.min-1. After ensuring sufficient anesthesia level, the surgical procedure was done with continuous hemodynamics monitoring and recording. While participants in the ITM group underwent sham blocks; Sham blocks consisted of a non-invasive ultrasound scan, while a blunt needle was gently pressed on both sides.

Outcomes

Primary Outcome Measures

the severity of pain: VAS
VAS

Secondary Outcome Measures

the total analgesic consumption
AMOUNT
the severity of pain: VAS
VAS
the severity of pain: VAS
VAS
the severity of pain: VAS
VAS
the severity of pain: VAS
VAS
the severity of pain: VAS
VAS
the time for the first analgesic request
time
Participants' satisfaction
postoperative

Full Information

First Posted
March 1, 2019
Last Updated
July 19, 2019
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT03935412
Brief Title
The Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Comparison With Intrathecal Morphine After Elective Cesarean Section
Official Title
The Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Comparison With Intrathecal Morphine After Elective Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University

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
The aim of this study was to assess the analgesic efficacy of bilateral erector spinae plane block in comparison with intrathecal morphine after elective cesarean section under spinal anesthesia.
Detailed Description
140 parturient scheduled for elective cesarean section. We obtained a written informed consent for anesthesia from each patient after explaining to them the nature of study and possible complications. Parturient were eligible for enrollment if they met the following inclusion criteria: Parturient aged 18 - 40 years , with American Society of Anesthesiologists physical status (ASA) class Ι, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation. Exclusion criteria included significant hepatic, renal or cardiovascular diseases, local infection, bleeding disorders, any contraindication to intrathecal anesthesia and parturient had a known allergy to the study drugs. Participants were randomly divided into two groups (ITM; intrathecal morphine and ESPB; erector spinae plane block groups, with 70 participants in each) as simple randomization by computer-generated random numbers that were placed in separate opaque envelopes opened by responsible anesthesiologist just before intrathecal block. The participants, the study investigators and the data collectors were not aware of group allocation till the study end. Those in the ITM group were given 100 mcg of preservative-free morphine in addition local anesthetic (hyperbaric bupivacaine 10 mg) intrathecally during spinal anesthesia. While participants in the ESPB group were given only local anesthetic (hyperbaric bupivacaine 10 mg) intrathecally. Preoperative investigations including electrocardiogram (ECG), complete blood picture, renal function tests, liver function tests, and coagulation profile were done. All parturient were fast for 8 h preoperatively. Upon arrival to the operating room IV access was obtained (one peripheral venous cannula 18G) and standard monitoring including pulse oximetry, ECG and noninvasive blood pressure were placed. And 10 ml.kg-1 of Ringer lactate solution will be infused over 15 minutes as a preload. The responsible anesthesiologist then asked the parturient to turn into sitting position where the skin on the back sterilized and; Spinal anesthesia performed via a midline approach into the L4-5 interspaces using a 25 gauge Quincke spinal needle after giving 3 ml of lidocaine 2% as a subcutaneous infiltration. After confirming free CSF flow through the needle a 10mg of hyperbaric bupivacaine 0.5 % was slowly injected for those in the ESPB group; and for those in the ITM group intrathecal injection of 10mg of hyperbaric bupivacaine 0.5 % in addition to 100 mcg of preservative-free morphine. Then, the parturient immediately placed in the supine position with 15° left tilt, and an oxygen mask was applied at 2 l.min-1. After ensuring sufficient anesthesia level, the surgical procedure was done with continuous hemodynamics monitoring and recording. If the systolic blood pressure (SBP) decreased to 20% below the baseline or less than 90 mmHg, ephedrine 5 mg will be administered intravenously. Also, if HR will be less than 50 beats/ min, atropine sulfate 0.5 mg will be administered intravenously. Upon delivery of the fetus, ten units of oxytocin were given by IV infusion. By the end of surgery parturient in the ESPB underwent bilateral ESPB at the level of T9 using a linear ultrasound (US) transducer (Phillips Saronno Italy) the transducer was placed vertically3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine 22-G short bevel needle (spinocan, B.Braun melsungen AG, Germany) was inserted in cranial-caudal direction towards the transvers process using in plane technique until the needle cross all the muscles then interfascial injection of 20ml 0.5% bupivacaine was done after ensuring negative aspiration, the procedure was repeated following the same steps on the other side of the back. While participants in the ITM group underwent sham blocks; Sham blocks consisted of a non-invasive ultrasound scan, while a blunt needle was gently pressed on both sides. We instructed the participants to report any signs of local anesthetic toxicity throughout injection e.g. change in mental status, anxiety, oral numbness and ringing in ears. For all participants spinal level and numerical rating scale were assessed and recorded before the block. At the end of surgery, parturient were transferred to postoperative anesthesia care unit (PACU) with standard monitoring applied. Any intraoperative or postoperative nausea or vomiting was managed with 10 mg metoclopramide. All participants received 30 mg ketorolac intravenously with the time of ESPB or sham blocks. Participants were transferred to obstetrics ward after fulfilling the criteria of modified Aldrete scoring system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Erector spinae plane block, morphine, cesarean section, postoperative analgesia, spinal anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ES Erector Spinae Plane Block
Arm Type
Active Comparator
Arm Description
By the end of surgery parturient in the ESPB underwent bilateral ESPB at the level of T9 using a linear ultrasound (US) transducer (Phillips Saronno Italy) the transducer was placed vertically3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine 22-G short bevel needle (spinocan, B.Braun melsungen AG, Germany) was inserted in cranial-caudal direction towards the transvers process using in plane technique until the needle cross all the muscles then interfascial injection of 20ml 0.5% bupivacaine was done after ensuring negative aspiration, the procedure was repeated following the same steps on the other side of the back.
Arm Title
intrathecal morphine ITM
Arm Type
Sham Comparator
Arm Description
participant in the ITM group intrathecal injection of 10mg of hyperbaric bupivacaine 0.5 % in addition to 100 mcg of preservative-free morphine. Then, the parturient immediately placed in the supine position with 15° left tilt, and an oxygen mask was applied at 2 l.min-1. After ensuring sufficient anesthesia level, the surgical procedure was done with continuous hemodynamics monitoring and recording. While participants in the ITM group underwent sham blocks; Sham blocks consisted of a non-invasive ultrasound scan, while a blunt needle was gently pressed on both sides.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
Erector Spinae Plane Block
Primary Outcome Measure Information:
Title
the severity of pain: VAS
Description
VAS
Time Frame
8 hour
Secondary Outcome Measure Information:
Title
the total analgesic consumption
Description
AMOUNT
Time Frame
24 hour
Title
the severity of pain: VAS
Description
VAS
Time Frame
immediately in PACU
Title
the severity of pain: VAS
Description
VAS
Time Frame
4 hours
Title
the severity of pain: VAS
Description
VAS
Time Frame
12 hours
Title
the severity of pain: VAS
Description
VAS
Time Frame
16 hours
Title
the severity of pain: VAS
Description
VAS
Time Frame
24 hours
Title
the time for the first analgesic request
Description
time
Time Frame
24 hours
Title
Participants' satisfaction
Description
postoperative
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists physical status (ASA) class Ι, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation Exclusion Criteria: included significant hepatic, renal or cardiovascular diseases, local infection, bleeding disorders, any contraindication to intrathecal anesthesia and parturient had a known allergy to the study drugs.
Facility Information:
Facility Name
Faculty of Medicine
City
Fayoum
ZIP/Postal Code
63511
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
27997492
Citation
Ueshima H, Otake H. Similarities Between the Retrolaminar and Erector Spinae Plane Blocks. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):123-124. doi: 10.1097/AAP.0000000000000526. No abstract available.
Results Reference
background
PubMed Identifier
14984863
Citation
Leung AY. Postoperative pain management in obstetric anesthesia--new challenges and solutions. J Clin Anesth. 2004 Feb;16(1):57-65. doi: 10.1016/j.jclinane.2003.02.012.
Results Reference
result

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The Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Comparison With Intrathecal Morphine After Elective Cesarean Section

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