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Bilateral Ultrasound Guided ESP Block Versus TAP Block on Post-operative Analgesia After Total Abdominal Hysterectomy

Primary Purpose

Post-operative Analgesia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
1) Ultrasound guided Erector spinae block
Ultrasound guided transversus abdominis plane block
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Analgesia

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female Patient.
  • Patient acceptance.
  • Age (40-60) years old.
  • American Society of Anaesthesiologist (ASA) I / II
  • Elective total abdominal hysterectomy under general anesthesia.
  • patient With Body Mass Index (BMI) (25-35kg/m²)

Exclusion Criteria:

  • Patient refusal.
  • Local infection at site of puncture.
  • Altered mental status.
  • History of allergy to study drugs ( bupivacaine, morphine).
  • Patients with chronic pain.
  • Patients with severe hepatic or kidney impairment.
  • Patients having a history of hematological disorders, including coagulation abnormality.

Sites / Locations

  • Zagazig University Hospitsals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Erector Spinae Plane Block

transversus abdominis plane block

Arm Description

Bilateral Ultrasound Guided Erector Spinae Plane Block

Ultrasound guided transversus abdominis plane block

Outcomes

Primary Outcome Measures

The total amount of morphine given to each patient
The total amount of morphine given to each patient during the first 24h of postoperative period
The time to first call to analgesia (morphine)
morphine (rescue analgesic) will be given if VAS>3.
Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988).
1- Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988). A commonly used visual analog scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. VAS score will be assessed at 30 minutes, 2hs, 4hs, 6hs, 12hs, and 24hs postoperative and IV increment of 3mg morphine (rescue analgesic) will be given if VAS>3.
Pain intensity using Visual analogue Scale (VAS)
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Pain intensity using Visual analogue Scale (VAS)
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Pain intensity using Visual analogue Scale (VAS)
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Pain intensity using Visual analogue Scale (VAS)
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Pain intensity using Visual analogue Scale (VAS)
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
"Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"
"Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"

Secondary Outcome Measures

Over all patient satisfaction
Over all patient satisfaction:The patients will be asked to rate the overall degree of satisfaction of the analgesia using a 1-3 verbal scale (1 = unsatisfactory analgesia, 2 = satisfactory analgesia, and 3 = excellent analgesia) (Ross et al., 2009).

Full Information

First Posted
May 23, 2019
Last Updated
October 15, 2019
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT03965156
Brief Title
Bilateral Ultrasound Guided ESP Block Versus TAP Block on Post-operative Analgesia After Total Abdominal Hysterectomy
Official Title
Bilateral Ultrasound Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block on Post-operative Analgesia After Total Abdominal Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 11, 2019 (Actual)

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
Abdominal hysterectomy is an open surgical procedure associated with considerable post-operative pain. Narcotics are often required during patient recovery but can result in adverse side effects. Transversus abdominis plane block(TAP block) is a regional anesthetic technique that is found to be effective as post-operative analgesia after total abdominal hysterectomy. Recently, erector spinae plane block(ESP)block is found to be safe, and simple regional anesthetic technique that decrease total opioid consumption in patient undergoing breast, or abdominal surgery. The aim is to compare the efficacy of bilateral erector spinae plane block, and bilateral transversus abdominis plane block on postoperative analgesia in patients after abdominal hysterectomy under general anesthesia, and their need for opioid. Hypothesis Null hypothesis (H0): No difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia. Alternative hypothesis (H1): There are difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia.
Detailed Description
Sample size: Assuming that Mean±SD of reduced pain scores in erector spinae plane block is 4.7±3.7 versus 2.5±1 in transversus abdominis plane block.So, the total sample size is 48 cases (24 in each group) using Open Source Statistics for Public Health (open Epi) with confidence interval 95% and power of test is 80%. d) Method of sample collection: Forty eight female patients will be divided into two groups by a computer-generated randomization table: Group (ES) (n=24): will receive bilateral ultrasound guided erector spinae plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) at the level of T9. Group (TA) (n=24): will receive bilateral ultrasound guided transversus abdominis plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector Spinae Plane Block
Arm Type
Active Comparator
Arm Description
Bilateral Ultrasound Guided Erector Spinae Plane Block
Arm Title
transversus abdominis plane block
Arm Type
Active Comparator
Arm Description
Ultrasound guided transversus abdominis plane block
Intervention Type
Procedure
Intervention Name(s)
1) Ultrasound guided Erector spinae block
Intervention Description
In the lateral position, after skin sterilization, erector spinae plane block will be performed at the level of T9. Counting down from the spine of seventh cervical vertebrae, the spine of the nine thoracic vertebrae (T9). A linear low frequency ultrasound transducer (US) (3-5 MHz) will placed sagittal 3cm lateral to midline to visualize the muscles of the back, transverse process and simmering pleura in between transverse processes. A 22-gauge short bevel needle will be inserted in cranial-caudal direction towards transverse process (TP) in plane to the US transducer until needle touched the TP crossing all the muscles. The location of the needle tip will be confirmed by visible normal saline fluid separating erector spinae muscle off the bony shadow of the transverse process on ultrasound imaging. Then 20 ml of bupivacaine 0.375% plus plus 5ug/ml adrenaline (1:200000) will be injected. The procedure will be repeated following the same steps on the other side of the back.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided transversus abdominis plane block
Intervention Description
in supine position and after skin sterilization. The linear high frequency transducer (6-13 MHz) will be placed in the transverse plane to the the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest. The three abdominal wall muscles (external oblique, internal oblique, and transversus abdominis) are visualized. The needle inserted in plane and advanced anterior to posterior under continual visualization until the tip between the internal oblique and the transversus abdominis muscle. After negative aspiration, a 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) will be injected. The success of the injection will be confirmed by separation of the internal oblique and transversus abdominis with a distinct pocket of local anesthetic in between. The procedure will be repeated following the same steps on the other side.
Primary Outcome Measure Information:
Title
The total amount of morphine given to each patient
Description
The total amount of morphine given to each patient during the first 24h of postoperative period
Time Frame
the first 24 hours postoperative.
Title
The time to first call to analgesia (morphine)
Description
morphine (rescue analgesic) will be given if VAS>3.
Time Frame
first call to morphine up to 24 hours postoperative.
Title
Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988).
Description
1- Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988). A commonly used visual analog scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. VAS score will be assessed at 30 minutes, 2hs, 4hs, 6hs, 12hs, and 24hs postoperative and IV increment of 3mg morphine (rescue analgesic) will be given if VAS>3.
Time Frame
at 30 minutes postoperative.
Title
Pain intensity using Visual analogue Scale (VAS)
Description
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Time Frame
at 2 hours postoperative.
Title
Pain intensity using Visual analogue Scale (VAS)
Description
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Time Frame
at 4 hours postoperative.
Title
Pain intensity using Visual analogue Scale (VAS)
Description
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Time Frame
at 6 hours postoperative.
Title
Pain intensity using Visual analogue Scale (VAS)
Description
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Time Frame
at 12 hours postoperative.
Title
Pain intensity using Visual analogue Scale (VAS)
Description
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Time Frame
at 24 hours postoperative.
Title
"Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"
Description
"Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"
Time Frame
Up to 24 hours postoperative.
Secondary Outcome Measure Information:
Title
Over all patient satisfaction
Description
Over all patient satisfaction:The patients will be asked to rate the overall degree of satisfaction of the analgesia using a 1-3 verbal scale (1 = unsatisfactory analgesia, 2 = satisfactory analgesia, and 3 = excellent analgesia) (Ross et al., 2009).
Time Frame
all over 24 hours postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female Patient. Patient acceptance. Age (40-60) years old. American Society of Anaesthesiologist (ASA) I / II Elective total abdominal hysterectomy under general anesthesia. patient With Body Mass Index (BMI) (25-35kg/m²) Exclusion Criteria: Patient refusal. Local infection at site of puncture. Altered mental status. History of allergy to study drugs ( bupivacaine, morphine). Patients with chronic pain. Patients with severe hepatic or kidney impairment. Patients having a history of hematological disorders, including coagulation abnormality.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alshaimaa Kamel, M.D
Organizational Affiliation
faculty of medicine ,zagazig universty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig University Hospitsals
City
Zagazig
ZIP/Postal Code
055
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bilateral Ultrasound Guided ESP Block Versus TAP Block on Post-operative Analgesia After Total Abdominal Hysterectomy

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