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Rhomboid Intercostal Block Versus Serratus Anterior Plane Block

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
general anesthesia
general anesthesia plus Rhomboid intercostal block
Serratus anterior plane block
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring rhomboid intercostal block -serratus anterior plane block - thoracodorsal artery perforator flap

Eligibility Criteria

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

Inclusion Criteria: Adult patients aged between 21 to 60 years Undergoing pedicled thoracodorsal artery perforator flap following breast conserving surgery -General anesthesia Informed consents ASA I & II Body mass index 25-30 kg/m2. Exclusion Criteria: patients on anti-platelet, anticoagulant or B blocker drugs Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma, bleeding disorders, compromised renal or hepatic function history of allergy to local anesthesia or opioid analgesia, pregnancy.

Sites / Locations

  • Heba M FathiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group C:

Group R:

group S

Arm Description

control group who will be given general anesthesia only

Rhomboid intercostal block then general anesthesia

Serratus anterior plane block then general anesthesia

Outcomes

Primary Outcome Measures

tramadol consumption
The amount of tramadol consumption

Secondary Outcome Measures

Time of performance of block
Time needed to performance the block
Time to first dose of rescue analgesia
the first time that the patients need analgesia when VAS ≥ 3
Anticipated side effect
nausea, vomiting, local anesthesia toxicity, needle injury
Post operative patient's satisfaction
Post operative patient's satisfaction using 3 point scale (1= satisfied ,2=neutral, 3=not satisfied)

Full Information

First Posted
December 1, 2022
Last Updated
September 2, 2023
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05661279
Brief Title
Rhomboid Intercostal Block Versus Serratus Anterior Plane Block
Official Title
Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Analgesia After Thoracodorsal Artery Perforator Flap Following Partial Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2022 (Actual)
Primary Completion Date
October 2, 2023 (Anticipated)
Study Completion Date
October 30, 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
evaluate and compare the impact of ultrasound guided rhomboid intercostal block versus serratus anterior plane block for analgesia after thoracodorsal artery perforator flap following partial mastectomy
Detailed Description
To assess and compare quality of post- operative analgesia in each group. Time of performance of block in both groups. To assess and compare post-operative hemodynamics as well as anticipated adverse effects including nausea, vomiting, itching, hemorrhage, bradycardia, hypotension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
rhomboid intercostal block -serratus anterior plane block - thoracodorsal artery perforator flap

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group C:
Arm Type
Active Comparator
Arm Description
control group who will be given general anesthesia only
Arm Title
Group R:
Arm Type
Active Comparator
Arm Description
Rhomboid intercostal block then general anesthesia
Arm Title
group S
Arm Type
Active Comparator
Arm Description
Serratus anterior plane block then general anesthesia
Intervention Type
Procedure
Intervention Name(s)
general anesthesia
Intervention Description
general anesthesia
Intervention Type
Procedure
Intervention Name(s)
general anesthesia plus Rhomboid intercostal block
Intervention Description
the patients will be positioned in lateral decubitus with moving the scapula laterally by abducting the ipsilateral arm across the chest. under complete aseptic situations A high-frequency (6-12 MHz) linear US probe will be put medial to the medial border of the scapula in an oblique sagittal plane with the orientation marker directed cranially.at the T6-7 level, the tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection of 25mL of bupivacaine (0.25%) will be administered via 18-gauge Tuohy advanced in plane from a superomedial to an inferolateral direction, followed by general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Serratus anterior plane block
Intervention Description
The patient will be positioned supine with his arm abducts at 90°. the US high frequency (6-12 MHz) linear probe of sonosite M turbo ultrasonography (FUJIFIM sonosite, Inc., Bothell, WA, USA) will be put in sagittal plane at the midaxillary line. identification of the fascial plane between the serratus anterior muscle and external intercostal muscles will be performed between the fourth and fifth ribs in the midaxillary area . At this point the18-gauge Tuohy needle will be advanced in plane with injection of 25mL of 0.25 %, bupivacaine. followed by general anesthesia
Primary Outcome Measure Information:
Title
tramadol consumption
Description
The amount of tramadol consumption
Time Frame
at 24 hours postoperative
Secondary Outcome Measure Information:
Title
Time of performance of block
Description
Time needed to performance the block
Time Frame
time from positioning of ultrasound porbe till the end of block procedure.
Title
Time to first dose of rescue analgesia
Description
the first time that the patients need analgesia when VAS ≥ 3
Time Frame
during the first 24 hours postoperatively
Title
Anticipated side effect
Description
nausea, vomiting, local anesthesia toxicity, needle injury
Time Frame
at 24 hous post operative
Title
Post operative patient's satisfaction
Description
Post operative patient's satisfaction using 3 point scale (1= satisfied ,2=neutral, 3=not satisfied)
Time Frame
at 24 hours post operative

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: Adult patients aged between 21 to 60 years Undergoing pedicled thoracodorsal artery perforator flap following breast conserving surgery -General anesthesia Informed consents ASA I & II Body mass index 25-30 kg/m2. Exclusion Criteria: patients on anti-platelet, anticoagulant or B blocker drugs Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma, bleeding disorders, compromised renal or hepatic function history of allergy to local anesthesia or opioid analgesia, pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heba M Fathi, M.D
Phone
01000143938
Email
heba_elgendi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba M Fathi
Organizational Affiliation
faculty of human medicine ,zagazig university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heba M Fathi
City
Zagazig
ZIP/Postal Code
44519
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heba M Fathi, M.D
Email
heba_elgendi@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Rhomboid Intercostal Block Versus Serratus Anterior Plane Block

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