Rhomboid Intercostal Block Versus Serratus Anterior Plane Block

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Procedure: general anesthesia; Procedure: Serratus anterior plane block; Procedure: general anesthesia plus Rhomboid intercostal block

• Registration Number: NCT05661279
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2022-12-22
• Study Start: 2022-12-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-02
• Last Update Posted: 2023-09-06
• Primary Completion: 2023-10-02
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group S	general anesthesia	Serratus anterior plane block then general anesthesia
group S	Serratus anterior plane block	Serratus anterior plane block then general anesthesia
Group C:	general anesthesia	control group who will be given general anesthesia only
Group R:	general anesthesia	Rhomboid intercostal block then general anesthesia
Group R:	general anesthesia plus Rhomboid intercostal block	Rhomboid intercostal block then general anesthesia

Primary Outcome Measures

Name	Time	Method
tramadol consumption	at 24 hours postoperative	The amount of tramadol consumption

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Heba M Fathi; 🇪🇬 Zagazig, Egypt