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Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia

Primary Purpose

Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided Retrolaminar Block
ultrasound guided Erector Spinae Plane
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient acceptance.
  • 21 - 64 years of age.
  • American Society of Anesthesiologist physical status class I,II.
  • Body Mass Index 25-35 kg/m2.
  • Female patient undergoing elective unilateral modified radical mastectomy under general anesthesia.

Exclusion Criteria:

  • Coagulation disorders or anticoagulant therapy.
  • Known allergy to study drugs (Bupivacaine, Fentanyl)
  • Infection at the injection site.
  • Patients having chronic pain or on pain treatment.
  • Advanced renal, respiratory, hepatic or cardiovascular disorders.
  • Uncooperative patients.
  • Duration of surgery > 3hours.
  • Pregnant or lactating females.
  • Metastasis.

Sites / Locations

  • Zagazig University, Faculty of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ultrasound guided Retrolaminar Block

ultrasound guided erector spinae

Arm Description

ultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.

ultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.

Outcomes

Primary Outcome Measures

Total fentanyl dose.
The anesthesiologist will administer intravenous fentanyl 0.5 μg/kg when the heart rate or blood pressure of the patients increased >20% from basal measurements after exclusion of other causes.

Secondary Outcome Measures

pain intensity by Visual Analogue Scale
• Static and dynamic pain scores (VAS) at 30 minutes, 2, 4, 8, 12, 18 and 24 hours post-operatively. pain intensity will be evaluated by Visual Analogue Scale (VAS). VAS is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" imaginable on the other end. The patient will be asked to mark on this line where the intensity of the patient lies.
Time of requirement of rescue dose of Fentanyl.
Time of requirement of rescue dose of Fentanyl.
Total amount of postoperative Fentanyl
Total amount of Fentanyl consumed during the first 24 hours after surgery.
Post-operative nausea and vomiting
• Post-operative nausea and vomiting will be noticed, recorded using a categorical scoring system (0 = none, 1 = mild, 2 = moderate, 3 = severe) and treated, Ondansetron 4 mg IV will be administered in case of reported nausea and/or vomiting
Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.
Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.
Overall patient satisfaction
• Overall patient satisfaction at the end of the 24 hours post-operative using short assessment patient satisfaction scale (SAPS scale fully satisfied, neutral satisfied or unsatisfied)

Full Information

First Posted
August 25, 2020
Last Updated
May 26, 2023
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04531215
Brief Title
Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia
Official Title
Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 1, 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
Thoracic epidural anesthesia (TEA) and paravertebral block (PVB) have been utilized to give perioperative regional anesthesia in the trunk. TEA is technically troublesome in some cases, and is associated with a danger of serious complications, such as epidural hematoma, nerve injury, and hypotension. PVB has the benefit of perception of the needle position using ultrasonography. However, PVB is also additionally connected with a danger of serious complications, such as pneumothorax, hypotension, or nerve injury. Newer approaches to deal with PVB have been the focal point of numerous techniques lately; these methodologies incorporate retrolaminar block (RLB) and erector spinae plane block (ESPB)
Detailed Description
Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimized, as in a number of women it may chronically persist for months in the form of post-mastectomy pain syndrome. Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques as para-vertebral block and thoracic epidural anesthesia have possible complications and technical difficulties. The new alternative regional techniques such as erector spinae plane block and retrolaminar block are clinical trials for providing a safe and easy with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects. As percent of post-operative rescue analgesia is 16.7% and 60% for RLB group and ESPB group respectively. So, sample size is 46 patients (23 patients in each group). Sample was calculated using OPEN EPI program with confidence level 95% and power 80%.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ultrasound guided Retrolaminar Block
Arm Type
Active Comparator
Arm Description
ultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.
Arm Title
ultrasound guided erector spinae
Arm Type
Active Comparator
Arm Description
ultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.
Intervention Type
Drug
Intervention Name(s)
ultrasound guided Retrolaminar Block
Intervention Description
ultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side
Intervention Type
Drug
Intervention Name(s)
ultrasound guided Erector Spinae Plane
Intervention Description
ultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.
Primary Outcome Measure Information:
Title
Total fentanyl dose.
Description
The anesthesiologist will administer intravenous fentanyl 0.5 μg/kg when the heart rate or blood pressure of the patients increased >20% from basal measurements after exclusion of other causes.
Time Frame
from induction to end of surgery
Secondary Outcome Measure Information:
Title
pain intensity by Visual Analogue Scale
Description
• Static and dynamic pain scores (VAS) at 30 minutes, 2, 4, 8, 12, 18 and 24 hours post-operatively. pain intensity will be evaluated by Visual Analogue Scale (VAS). VAS is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" imaginable on the other end. The patient will be asked to mark on this line where the intensity of the patient lies.
Time Frame
at 30 minutes then at 2, 4, 8, 12, 18 and 24 hours post-operatively.
Title
Time of requirement of rescue dose of Fentanyl.
Description
Time of requirement of rescue dose of Fentanyl.
Time Frame
up to 24hour postoperative
Title
Total amount of postoperative Fentanyl
Description
Total amount of Fentanyl consumed during the first 24 hours after surgery.
Time Frame
up to 24hour postoperative
Title
Post-operative nausea and vomiting
Description
• Post-operative nausea and vomiting will be noticed, recorded using a categorical scoring system (0 = none, 1 = mild, 2 = moderate, 3 = severe) and treated, Ondansetron 4 mg IV will be administered in case of reported nausea and/or vomiting
Time Frame
up to 24hour postoperative
Title
Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.
Description
Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.
Time Frame
up to 24hour postoperative
Title
Overall patient satisfaction
Description
• Overall patient satisfaction at the end of the 24 hours post-operative using short assessment patient satisfaction scale (SAPS scale fully satisfied, neutral satisfied or unsatisfied)
Time Frame
up to 24hour postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient acceptance. 21 - 64 years of age. American Society of Anesthesiologist physical status class I,II. Body Mass Index 25-35 kg/m2. Female patient undergoing elective unilateral modified radical mastectomy under general anesthesia. Exclusion Criteria: Coagulation disorders or anticoagulant therapy. Known allergy to study drugs (Bupivacaine, Fentanyl) Infection at the injection site. Patients having chronic pain or on pain treatment. Advanced renal, respiratory, hepatic or cardiovascular disorders. Uncooperative patients. Duration of surgery > 3hours. Pregnant or lactating females. Metastasis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alshaimaa Kamel, M.D
Phone
01005593169
Ext
002
Email
AlshaimaaKamel80@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mai Alahmady, MBBCH
Phone
01000314543
Ext
002
Email
alahmadymai@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alshaimaa Kamel, M.D
Organizational Affiliation
Zagazig University
Official's Role
Study Chair
Facility Information:
Facility Name
Zagazig University, Faculty of medicine
City
Zagazig
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alshaimaa Kamel, M.D
Phone
01005593169
Ext
002
Email
AlshaimaaKamel80@yahoo.com
First Name & Middle Initial & Last Name & Degree
Alshaimaa Kamel, M.D

12. IPD Sharing Statement

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Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia

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