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Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
erector spinae plane (ESP) block
oblique subcostal transverse abdominis plane (TAP) block
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients scheduled for elective umbilical hernia repair.
  • Patient acceptance.
  • Both sex
  • Patient's age 21 - 60 years.
  • Patients with American Society of Anesthesiologists (ASA) physical status I, II.
  • BMI 25 - 30 kg m-2.

Exclusion Criteria:

  • Uncooperative patients and patients with psychological problems.
  • Patients with liver or renal impairment.
  • Patients with contraindication to regional anesthesia.
  • Patients with history of allergy to drug used in the study.
  • Patients with chronic pain.

Sites / Locations

  • Zagazig University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

erector spinae plane (ESP) block group ( (E) group)

oblique subcostal transverse abdominis plane (TAP) block ( (T) group) )

Arm Description

Under aseptic conditions, a high frequency linear transducer will be placed on the spinous process at T8 level on the parasagittal plane and then slid 2.5-3 cm laterally to visualize the transverse process and erector spinae muscle.

Under aseptic conditions, the probe will be initially placed below the xyphoid process to view the linea alba, then directed obliquely down the costal margin while keeping the rectus abdominis muscle in view. The transverse abdominis muscle come into view below the rectus abdominis muscle. The probe will be advanced further until the semilunaris is viewed.

Outcomes

Primary Outcome Measures

Postoperative analgesic requirements
measuring the total doses of analgesic required to relieve the pain

Secondary Outcome Measures

Postoperative pain severity using Visual Analogue scale
assessing pain severity using Visual Analogue scale (VAS) (0-100mm)
Postoperative pain severity using Verbal Rating Scale
assessing pain severity using Verbal Rating Scale (mild, moderate and severe)
Postoperative pain severity using Numeric Rating Scale
assessing pain severity using Numeric Rating Scale (NRS) (0-10; 0, no pain; 10, worst pain)
Postoperative heart rate changes
monitoring postoperative changes in the heart rate (HR) measured by beat per minute (BPM) and comparing it with the preoperative measures
Postoperative blood pressure changes
monitoring postoperative changes in the blood pressure (BP) measured by mm Hg and comparing it with the preoperative measures.
Incidence of postoperative side effects
recording any postoperative complications as nausea and vomiting
Duration of postoperative hospital stay
measuring the delay in discharging the patients postoperative because of the pain

Full Information

First Posted
December 22, 2021
Last Updated
July 11, 2023
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05286125
Brief Title
Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block
Official Title
Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block for Controlling Postoperative Pain After Umbilical Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Comparing the impact of bilateral erector spinae plane block and transverse abdominis plane block on improving quality of pain management after umbilical hernia repair.
Detailed Description
Postoperative pain is an important problem after umbilical hernia repair which has negative effects on patient's hemodynamics and cause delayed ambulation resulting in prolonged duration of hospital stay and poor patient satisfaction. Multiple analgesic strategies have been proposed including Non steroidal anti-inflammatory drugs (NSAIDs), opioids, epidural analgesia. Each of them has its limitations. Ultra¬sound guided regional anesthesia techniques for abdominal wall can be effective components of multimodal postoperative analgesia with limited side-effects Erector spinae plane (ESP) block is a promising para-spinal bock that can achieve both visceral and somatic abdominal analgesia if the injection was performed at a lower thoracic level. Transverse abdominis plane (TAP) block which is considered a peripheral nerve block that is aimed at anesthetizing nerves supplying the anterior abdominal wall. We will compare between erector spinae plane block and transverse abdominis plane block for controlling postoperative pain after umbilical hernia repair. Patients will be allocated randomly into two equal groups by a computer-generated randomization table Group (E) (n=26): Patients will receive erector spinae plane (ESP) block after completion of surgery. Group (T) (n= 26): Patients will receive oblique subcostal transverse abdominis plane (TAP) block after completion of surgery

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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
erector spinae plane (ESP) block group ( (E) group)
Arm Type
Active Comparator
Arm Description
Under aseptic conditions, a high frequency linear transducer will be placed on the spinous process at T8 level on the parasagittal plane and then slid 2.5-3 cm laterally to visualize the transverse process and erector spinae muscle.
Arm Title
oblique subcostal transverse abdominis plane (TAP) block ( (T) group) )
Arm Type
Active Comparator
Arm Description
Under aseptic conditions, the probe will be initially placed below the xyphoid process to view the linea alba, then directed obliquely down the costal margin while keeping the rectus abdominis muscle in view. The transverse abdominis muscle come into view below the rectus abdominis muscle. The probe will be advanced further until the semilunaris is viewed.
Intervention Type
Procedure
Intervention Name(s)
erector spinae plane (ESP) block
Intervention Description
Using the in plane technique, the needle will be advanced between the transverse process and erector spinae muscle. The correct location will be confirmed using 1ml of Local Anesthetic (LA) to view hydrodissection(12). 19ml of LA will be injected between the muscle and transverse process.
Intervention Type
Procedure
Intervention Name(s)
oblique subcostal transverse abdominis plane (TAP) block
Intervention Description
An echogenic needle will be inserted in-plane until the needle tip reaches the fascia between the rectus abdominis and the transverse abdominis muscles. Once the needle enters the TAP plane, a dynamic injection can be performed by advancing the needle under ultrasound guidance laterally in the pocket created by the initial injection of 5 - 10 mL of local anesthetic; as the needle is advanced, the remaining local anesthetic will be injected. This allows for a more lateral spread of the local anesthetic
Primary Outcome Measure Information:
Title
Postoperative analgesic requirements
Description
measuring the total doses of analgesic required to relieve the pain
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Postoperative pain severity using Visual Analogue scale
Description
assessing pain severity using Visual Analogue scale (VAS) (0-100mm)
Time Frame
24 hours postoperative
Title
Postoperative pain severity using Verbal Rating Scale
Description
assessing pain severity using Verbal Rating Scale (mild, moderate and severe)
Time Frame
24 hours postoperative
Title
Postoperative pain severity using Numeric Rating Scale
Description
assessing pain severity using Numeric Rating Scale (NRS) (0-10; 0, no pain; 10, worst pain)
Time Frame
24 hours postoperative
Title
Postoperative heart rate changes
Description
monitoring postoperative changes in the heart rate (HR) measured by beat per minute (BPM) and comparing it with the preoperative measures
Time Frame
24 hours postoperative
Title
Postoperative blood pressure changes
Description
monitoring postoperative changes in the blood pressure (BP) measured by mm Hg and comparing it with the preoperative measures.
Time Frame
24 hours postoperative
Title
Incidence of postoperative side effects
Description
recording any postoperative complications as nausea and vomiting
Time Frame
24 hours postoperative
Title
Duration of postoperative hospital stay
Description
measuring the delay in discharging the patients postoperative because of the pain
Time Frame
24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients scheduled for elective umbilical hernia repair. Patient acceptance. Both sex Patient's age 21 - 60 years. Patients with American Society of Anesthesiologists (ASA) physical status I, II. BMI 25 - 30 kg m-2. Exclusion Criteria: Uncooperative patients and patients with psychological problems. Patients with liver or renal impairment. Patients with contraindication to regional anesthesia. Patients with history of allergy to drug used in the study. Patients with chronic pain.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
michael A shaker, lecturer
Phone
01096457282
Ext
002
Email
michaeladelshaker@gamil.com
First Name & Middle Initial & Last Name or Official Title & Degree
salwa s ElSherbeny, lecturer
Phone
01128595629
Ext
002
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A shaker, lecturer
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig University hospital
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hala A ALsadek, professor
Phone
01224897773
Ext
002

12. IPD Sharing Statement

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Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block

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