Rhomboid Intercostal Block Versus Serratus Anterior Plane Block

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05661279
• Other study ID #: zu-IRB # 10060
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: September 2023
• Source: Zagazig University
• Contact: Heba M Fathi, M.D
• Phone: 01000143938
• Email: heba_elgendi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: October 30, 2023
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• general anesthesia
general anesthesia
• 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
• 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

Locations

Country	Name	City	State
Egypt	Heba M Fathi	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tramadol consumption	The amount of tramadol consumption	at 24 hours postoperative
Secondary	Time of performance of block	Time needed to performance the block	time from positioning of ultrasound porbe till the end of block procedure.
Secondary	Time to first dose of rescue analgesia	the first time that the patients need analgesia when VAS = 3	during the first 24 hours postoperatively
Secondary	Anticipated side effect	nausea, vomiting, local anesthesia toxicity, needle injury	at 24 hous post operative
Secondary	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