Rhomboid Intercostal Block Versus Serratus Anterior Plane Block

Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Analgesia After Thoracodorsal Artery Perforator Flap Following Partial Mastectomy

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: general anesthesia; Procedure: general anesthesia plus Rhomboid intercostal block; Procedure: Serratus anterior plane block

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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba M Fathi, M.D; Phone Number: 01000143938; Email: heba_elgendi@yahoo.com

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • Recruiting
    • Heba M Fathi
    • Contact: Heba M Fathi, M.D; Email: heba_elgendi@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 56 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group C: control group who will be given general anesthesia only	Procedure: general anesthesia; general anesthesia
Active Comparator: Group R: Rhomboid intercostal block then general anesthesia	Procedure: general anesthesia; general anesthesia; Procedure: general anesthesia plus Rhomboid intercostal block; 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
Active Comparator: group S; Serratus anterior plane block then general anesthesia	Procedure: general anesthesia; general anesthesia; Procedure: Serratus anterior plane block; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tramadol consumption	The amount of tramadol consumption	at 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of performance of block	Time needed to performance the block	time from positioning of ultrasound porbe till the end of block procedure.
Time to first dose of rescue analgesia	the first time that the patients need analgesia when VAS ≥ 3	during the first 24 hours postoperatively
Anticipated side effect	nausea, vomiting, local anesthesia toxicity, needle injury	at 24 hous post operative
Post operative patient's satisfaction	Post operative patient's satisfaction using 3 point scale (1= satisfied ,2=neutral, 3=not satisfied)	at 24 hours post operative

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Heba M Fathi, faculty of human medicine ,zagazig university

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2022
• Primary Completion (Estimated): October 2, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 2, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: rhomboid intercostal block -serratus anterior plane block - thoracodorsal artery perforator flap
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: zu-IRB # 10060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No