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Bilateral Erector Spinae Plane Block After Elective Cesarean Section

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ESPB and TAP block
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • aged 18 - 40 years
  • American Society of Anesthesiologists physical status ІІ, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation.

Exclusion Criteria:

  • Patient refusal.
  • Contraindications to regional anesthesia.
  • Known allergy to the study drugs.
  • Severe cardiovascular, renal or hepatic diseases.
  • Bleeding disorders.
  • Local infection.

Sites / Locations

  • Faculty of Medicine
  • Mohamed Hamed
  • Mohamed

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ES Erector Spinae Plane Block

TAP Transversus Abdominis Plane Block

Arm Description

bilateral ESP block at the level of T9 by a linear ultrasound (US) transducer (Phillips Saronno Italy) placed vertically 3cm lateral to the midline to visualize the back muscles superior to the transverse process. A 22-G short bevel needle (spinocan, B.Braun, melsungen AG, Germany) will be inserted in cranial-caudal direction until it make contact with the transverse process. Confirmation of the correct position of the tip of the needle is by injection of 1 ml saline causing hydrodisscetion between the erector spinae muscle and the transverse process. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected.The same procedure is done on the other side of the back.

bilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis. A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side.

Outcomes

Primary Outcome Measures

duration of analgesia of the two blocks
time

Secondary Outcome Measures

Visual analogue scale
Visual analogue scale for pain
Visual analogue scale
Visual analogue scale for pain
Visual analogue scale
Visual analogue scale for pain
Visual analogue scale
Visual analogue scale for pain
Visual analogue scale
Visual analogue scale for pain
the first request to analgesia
duration
total analgesic consumption
amount

Full Information

First Posted
July 8, 2019
Last Updated
January 17, 2020
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT04016688
Brief Title
Bilateral Erector Spinae Plane Block After Elective Cesarean Section
Official Title
Comparative Study Between the Analgesic Effect of Erector Spinae Plane Block and Transversus Abdominis Plane Block After Elective Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 1, 2020 (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 work is to assess and compare the analgesic efficacy of bilateral erector spinae plane block with that of bilateral transversus abdominis plane block after elective cesarean section.
Detailed Description
Inclusion criteria: - Parturients aged 18 - 40 years with American Society of Anesthesiologists physical status І or ІІ, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation. Exclusion criteria: Patient refusal. Contraindications to regional anesthesia. Known allergy to the study drugs. Severe cardiovascular, renal or hepatic diseases. Bleeding disorders. Local infection. Participants will be randomly divided into two groups: Group A will receive bilateral Erector spinae plane block. (n=30) Group B will receive bilateral Transversus abdominis plane block. (n=30) Simple randomization will be performed by computer-generated random numbers that will be placed in separate opaque envelopes that will be opened by responsible anesthesiologist just before the intrathecal block. Routine preoperative investigations including electrocardiogram (ECG), complete blood picture, renal function tests, liver function tests, and coagulation profile will be done. All parturients will fast for 8 h preoperatively. IV access will be obtained (one peripheral venous cannula 18G) and standard monitoring including pulse oximetry, ECG and noninvasive blood pressure will be placed for measurement of the hemodynamic variability. Ten ml.kg-1 of Ringer lactate solution will be infused over 15 minutes as a preload. The parturient will be asked to turn into sitting position where the skin on the back will be sterilized and spinal anesthesia will be 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 % will be slowly injected for both groups. The parturient will be placed in the supine position with 15° left tilt, and an oxygen mask will be applied at 2 L.min-1. The surgical procedure will start after sufficient anesthesia level is obtained, with continuous hemodynamics monitoring and recording. After delivery of the fetus, 10 units of oxytocin will be given by IV infusion. By the end of the surgery, patients in group (A) received bilateral ESP block. First in the supine position, sham TAP block was done then the patient was turned into the lateral position to receive ESP block and after proper skin sterilization then the vertebrae were counted from cephalad to caudal direction until T9 spinous process was reached as the first palpable spinous process is C7 and at this level a linear ultrasound (US) transducer (Phillips Saronno Italy) was placed vertically 3cm lateral to the midline to visualize the back muscles superior to the transverse process. -A 22-G short bevel needle (spinocan, B.Braun, melsungen AG, Germany) was inserted in cranial-caudal direction until it make contact with the transverse process. Confirmation of the correct position of the tip of the needle was by injection of 1 ml saline causing hydrodisscetion between the erector spinae muscle and the transverse process. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine was injected. The same procedure was done on the other side of the back. -Patients in group (B) received bilateral TAP block. First in the supine position a linear ultrasound (US) transducer (Phillips Saronno Italy) was placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis. -A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) was introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine was injected causing an elliptical separation of the two muscles. The same procedure was done on the other side. Then the patient was placed in the lateral position to do sham ESP block. The patients will be instructed to notify us if they have experienced any signs of systemic toxicity as circumoral or tongue numbness, dizziness, visual and auditory disturbances as difficulty focusing and tinnitus. Spinal level will be assessed and recorded before both blocks in all patients, then they will be transferred to postoperative anesthesia care unit (PACU) with standard monitoring. After surgery the patient will receive paracetamol 1gm IV infusion/8 hours, ketorolac 30 mg IV/12hours as a multimodal analgesia for postoperative pain. Postoperative pain will be assessed by Visual analog scale (VAS) for pain (ranging from 0 to 10, where 0 no pain and 10 the worst possible pain) at time intervals at 0 hour, 4hours, 8 hours, 12hours and 24 hours. Postoperative mean arterial blood pressure and heart rate will be assessed and recorded. Time for the first request to analgesia and total analgesic consumption will be recorded in the first 24 hours after surgery. Any complications as nausea and vomiting will be recorded. Sensory block by a pin prick test will be assessed (0: normal sensation, 1: decreased pain sensation, 2: loss of pain sensation). The duration of the sensory block which is the time interval between performance of the block and complete resolution of anesthesia will be assessed and recorded every 2 hours. Patient satisfaction with analgesia will be assessed as (0: poor, 1: good, 2: excellent).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single-blind
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ES Erector Spinae Plane Block
Arm Type
Active Comparator
Arm Description
bilateral ESP block at the level of T9 by a linear ultrasound (US) transducer (Phillips Saronno Italy) placed vertically 3cm lateral to the midline to visualize the back muscles superior to the transverse process. A 22-G short bevel needle (spinocan, B.Braun, melsungen AG, Germany) will be inserted in cranial-caudal direction until it make contact with the transverse process. Confirmation of the correct position of the tip of the needle is by injection of 1 ml saline causing hydrodisscetion between the erector spinae muscle and the transverse process. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected.The same procedure is done on the other side of the back.
Arm Title
TAP Transversus Abdominis Plane Block
Arm Type
Active Comparator
Arm Description
bilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis. A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side.
Intervention Type
Procedure
Intervention Name(s)
ESPB and TAP block
Intervention Description
bilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis. A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.5 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side.
Primary Outcome Measure Information:
Title
duration of analgesia of the two blocks
Description
time
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Visual analogue scale
Description
Visual analogue scale for pain
Time Frame
immediatiy in pacu
Title
Visual analogue scale
Description
Visual analogue scale for pain
Time Frame
4 hours
Title
Visual analogue scale
Description
Visual analogue scale for pain
Time Frame
8 hours
Title
Visual analogue scale
Description
Visual analogue scale for pain
Time Frame
12 hours
Title
Visual analogue scale
Description
Visual analogue scale for pain
Time Frame
24 hours
Title
the first request to analgesia
Description
duration
Time Frame
24 hours
Title
total analgesic consumption
Description
amount
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
18 years
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 18 - 40 years American Society of Anesthesiologists physical status ІІ, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation. Exclusion Criteria: Patient refusal. Contraindications to regional anesthesia. Known allergy to the study drugs. Severe cardiovascular, renal or hepatic diseases. Bleeding disorders. Local infection.
Facility Information:
Facility Name
Faculty of Medicine
City
Fayoum
ZIP/Postal Code
63511
Country
Egypt
Facility Name
Mohamed Hamed
City
Fayoum
ZIP/Postal Code
63511
Country
Egypt
Facility Name
Mohamed
City
Fayoum
ZIP/Postal Code
65345
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
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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Bilateral Erector Spinae Plane Block After Elective Cesarean Section

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