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Postoperative Anelgesic Effect of Rhomboid Intercostal Nerve Block Versus Erector Spinae Plane Block

Primary Purpose

Post Operative Pain

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Rhomboid intercostal plane block
Sponsored by
ghada fouad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Operative Pain focused on measuring Modified Radical Mastectomy, Rhomboid Intercostal Nerve Block, Erector Spinae Plane Block .

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • - Female patients aged between 25-65 years.
  • ASA physical status I or II.
  • Scheduled for elective unilateral modified radical mastectomy

Exclusion Criteria:

  • - Patient refusal.
  • Infection at the site of injection.
  • Hypersensitivity to the local anesthetic
  • Bleeding disorders.
  • Patients with cardiac, hepatic, and renal failure.
  • BMI ≥40 kg/m2
  • Patient with serum cr > 1.5

Sites / Locations

  • Mansoura University
  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

rhomboid intercostal plane block

Erector spinae plane block

Arm Description

as in intervention description

As in intervention description

Outcomes

Primary Outcome Measures

The total analgesic requirements during the first 24 hours postoperative.
All patients will receive standard postoperative analgesia (1gm paracetamol every 8 hours IV).

Secondary Outcome Measures

The duration of effective analgesia
time interval between the end of surgery and first analgesic request .

Full Information

First Posted
July 6, 2022
Last Updated
October 10, 2022
Sponsor
ghada fouad
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1. Study Identification

Unique Protocol Identification Number
NCT05452369
Brief Title
Postoperative Anelgesic Effect of Rhomboid Intercostal Nerve Block Versus Erector Spinae Plane Block
Official Title
Ultrasound Guided Rhomboid Intercostal Nerve Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy:A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ghada fouad

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Despite of analgesic effect of intravenous analgesic medications at intraoperative and postoperative time , The regional anesthetic techniquehas more benefits suchbetter control of Acute pain and hence less chronic pain and decreases the need for opioids and analgesics to preserve immune function which responsible for higher rates of infection and local recurrence, even metastasis . New regional anesthetic technique for modified radical mastectomy discovered recently called rhomboid intercostal nerve block that will compared against erector spinae plane block .
Detailed Description
The aim of this study is to compare the post-operative analgesic effect of ultrasound-guided rhomboid intercostal nerve block versus erector spinae plane block as regard total analgesic requirements, duration of effective analgesia,postoperative visual analog score (VAS), peri-operative hemodynamics,peri-operative complications and incidence of chronic postmastectomy pain.The technique of rhomboid intercostal nerve block: After induction of anesthesia, the patient will be positioned in lateral decubitus with the operated side above. After sterilization of the patient's back, A linear ultrasound transducer (6-12 MHz) will place medial to the lower border of the scapula with the orientation marker directed cranially. The ultrasound landmarks, trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung will be identified. The tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection is administered at the T4-5. 80mm 21-gage needle will be inserted in the plane view of the ultrasound probe at the level of T4-5. After negative aspiration of blood or air, the rhomboid intercostal plane was hydro located with 2 mL of normal saline to confirm the correct needle tip position. A single injection of 30 ml of bupivacaine 0.25% will be applied into the interfacial plane between the rhomboid major and intercostal muscles. The spread of local anesthetic solution under the rhomboid muscle will be visualized by ultrasonography. The technique of Erector spinae plane block (ESP): After induction of anesthesia, the patient will be positioned in lateral decubitus with the operated side above. After sterilization of the patient's back, A linear ultrasound probe willplace 3-cm lateral to the midline at the level of T5 interspinous space and transverse process and three muscles willidentify: trapezius, rhomboid major, and erector spinae. A 10-cm needle was inserted craniocaudally in-plane, to reach the transverse process. After hydrodissection of the plane with 3 mL of normal saline, 30 ml of 0.25% bupivacainewilldeposit and thus erector spinae muscle will lift off the transverse process. Block assessment will be performed using ice cube withtemperature of 4°C at midclavicular linein post anesthesia care unit after Full recovery which be confirmed when Aldrete's score ≥9 . Block success means at least3 dermatomal segments should be having decreased sensation to cold. Failed block will be excluded from the study and patient will replaced by another patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Modified Radical Mastectomy, Rhomboid Intercostal Nerve Block, Erector Spinae Plane Block .

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
- Two arms: rhomboid intercostal plane block is the first group Erector spinae plane block is the second group
Masking
ParticipantOutcomes Assessor
Masking Description
- double-blind comparative study.
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rhomboid intercostal plane block
Arm Type
Experimental
Arm Description
as in intervention description
Arm Title
Erector spinae plane block
Arm Type
Experimental
Arm Description
As in intervention description
Intervention Type
Drug
Intervention Name(s)
Rhomboid intercostal plane block
Other Intervention Name(s)
fascial plane block
Intervention Description
- 30 mL bupivacaine 0.25% will injected ultrasound-guided in rhomboid intercostal fascial plane .
Primary Outcome Measure Information:
Title
The total analgesic requirements during the first 24 hours postoperative.
Description
All patients will receive standard postoperative analgesia (1gm paracetamol every 8 hours IV).
Time Frame
0,2,4,6,8,10,12,16,20,24 hours postoperatively
Secondary Outcome Measure Information:
Title
The duration of effective analgesia
Description
time interval between the end of surgery and first analgesic request .
Time Frame
0,2,4,6,8,10,12,16,20,24 hours postoperatively

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients undergoing modified radical mastectomy surgery
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Female patients aged between 25-65 years. ASA physical status I or II. Scheduled for elective unilateral modified radical mastectomy Exclusion Criteria: - Patient refusal. Infection at the site of injection. Hypersensitivity to the local anesthetic Bleeding disorders. Patients with cardiac, hepatic, and renal failure. BMI ≥40 kg/m2 Patient with serum cr > 1.5
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed y makharita, MD
Organizational Affiliation
Professor OFanesthesia Mansoura university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
ghada f amer, MD
Organizational Affiliation
Assistant professor of anesthesia Mansoura university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ahmed E Kamal, resident
Organizational Affiliation
resident of anesthesia mansoura university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
Facility Name
Mansoura University
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

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Postoperative Anelgesic Effect of Rhomboid Intercostal Nerve Block Versus Erector Spinae Plane Block

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