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Transversus Abdominis Plane Block Versus Erector Spinae Plane Block

Primary Purpose

Postoperative Pain, Laparotomy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
transversus abdominis plane block
erector spinae plane block
control group
Sponsored by
Hassan Mokhtar Elshorbagy Hetta
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, Transversus Abdominis Plane Block

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1. Age18-70 . 2. Both gender . 3 .Emergency laparotomies . 4. ASA I-III .

Exclusion Criteria:

  1. Drug allergy .
  2. Morbid obesity (BMI >40 kg/m2) .
  3. Psychiatric disorder .
  4. Opioid dependence .
  5. patient refuse

Sites / Locations

  • Minia University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Group I (A group)

Group II (B group)

Group III (C group)

Arm Description

31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).

31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).

31 patients anesthetized with the protocol followed by Minia University Hospital

Outcomes

Primary Outcome Measures

Time of First Post Operative Analgesic Request
the pain will be assisted based on the time for the first dose of rescue analgesia
Postoperative Total Fentanyl Requirement
The total amount of postoperative fentanyl in milligram was given to the patient as rescue analgesia during 24 hours

Secondary Outcome Measures

Incidence of Any Adverse Events
adverse events related to technique or drugs

Full Information

First Posted
May 4, 2019
Last Updated
June 18, 2020
Sponsor
Hassan Mokhtar Elshorbagy Hetta
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1. Study Identification

Unique Protocol Identification Number
NCT03989570
Brief Title
Transversus Abdominis Plane Block Versus Erector Spinae Plane Block
Official Title
Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Patients Undergoing Emergency Laparotomies.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hassan Mokhtar Elshorbagy Hetta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The TAP block, first described by Rafi in 2001, is comprised of deposition of a local anesthetic into the anatomical plane between the internal oblique and transverses abdominis muscles, where thess thoracoabdominal nerves (T6-L1) contribute to the main sensory supply of the skin, muscles, and parietal peritoneum of the anterior abdominal wall. These nerves branch and communicate extensively with each other in the TAP . Erector spinae plane (ESP) block is a recently described interfascial block in which the local anaesthectic is placed over or below the plane of the erector spinae muscle, near where the spinal nerves come out from the spine before they start to divide. Some publications have shown its effectiveness in treating thoracic and abdominal postoperative pain. Postoperative pain is the major obstacle for early postoperative ambulation and increases the risk of venous thromboembolism, respiratory complications and prolongs the hospital stay. Parietal pain is the chief component of postoperative pain after abdominal surgeries. Large doses of opioids are required to mitigate this pain, but they are poorly tolerated. Multimodal analgesia is effective in handling postoperative pain and in attenuating the side effects of large doses of a single analgesic .
Detailed Description
Group I (A group): Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side). Group II (B group): Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side). Group III (C group): anesthetized with the protocol followed by Minia University Hospital The medication will be prepared and supplied in similar syringes by an anesthetist not included in the management of the patint or data collection. Methods: Following placement of the standard monitors, intravenous access will secured and the patients will started on IV fluids. Anesthesia will be induced with 0.04 mg/kg midazolam, 2 μg/kg fentanyl, and titrated doses of propofol. Endotracheal intubation will facilitated with 0.5 mg/kg of atracurium. Isoflurane 1.2%, will be used for anesthetic maintenance After induction of anesthesia, stabilizing the patient's hemodynamics, and before surgical incision, ESB & TAP block will be performed. With the patient in the supine position, the site of the ultrasound and needle entry will be sterilized. The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected. Then the patient will turn in lateral position, the site of the ultrasound and needle entry will be sterilized. The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Laparotomy
Keywords
Erector Spinae Plane Block, Transversus Abdominis Plane Block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (A group)
Arm Type
Experimental
Arm Description
31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).
Arm Title
Group II (B group)
Arm Type
Active Comparator
Arm Description
31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).
Arm Title
Group III (C group)
Arm Type
Placebo Comparator
Arm Description
31 patients anesthetized with the protocol followed by Minia University Hospital
Intervention Type
Procedure
Intervention Name(s)
transversus abdominis plane block
Intervention Description
The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected
Intervention Type
Procedure
Intervention Name(s)
erector spinae plane block
Intervention Description
The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Time of First Post Operative Analgesic Request
Description
the pain will be assisted based on the time for the first dose of rescue analgesia
Time Frame
24 hours
Title
Postoperative Total Fentanyl Requirement
Description
The total amount of postoperative fentanyl in milligram was given to the patient as rescue analgesia during 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Incidence of Any Adverse Events
Description
adverse events related to technique or drugs
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Age18-70 . 2. Both gender . 3 .Emergency laparotomies . 4. ASA I-III . Exclusion Criteria: Drug allergy . Morbid obesity (BMI >40 kg/m2) . Psychiatric disorder . Opioid dependence . patient refuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagy S. Ali, MD
Organizational Affiliation
Minia University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Abeer A Hassanien
Organizational Affiliation
Minia University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Minia University Hospital
City
Minya
ZIP/Postal Code
61511
Country
Egypt

12. IPD Sharing Statement

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Transversus Abdominis Plane Block Versus Erector Spinae Plane Block

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