Combined PECS II and Transeversus Thoracic Plane Blocks Vs Serratus Anterior Plane Block in Modified Radical Mastectomy

Serratus Anterior Plane Block Clinical Trial

Official title:

Analgesic Efficacy of Combined Ultrasound-Guided PECS II and Transeversus Thoracic Plane Blocks Versus Ultrasound-Guided Serratus Anterior Plane Block in Modified Radical Mastectomy: A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908878
• Other study ID #: 33972/7/20
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 2, 2022

Study information

• Verified date: November 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the analgesic efficacy of combined ultrasound (US)-guided pectoral nerve (PECS) block II and transversus thoracic plane (TTP) block versus US-guided serratus anterior plane (SAP) block in female patients undergoing modified radical mastectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Female patients

• Aged 21-60 years

• ASA physical status I, II

• Scheduled for unilateral modified radical mastectomy

Exclusion Criteria:

1. Patient refusal.

2. Known hypersensitivity to local anesthetics.

3. Body mass index > 35 kg /m2.

4. Uncooperative or psychiatric patients.

5. Infection at the injection site.

6. Coagulation disorder.

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Modified Radical Mastectomy
• Serratus Anterior Plane Block

Intervention

Procedure:
• Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block
Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia.
• Serratus anterior plane (SAP) block
Patients will receive US-guided SAP block after induction of general anesthesia.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Tanta University	Tanta	Elgharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total amount rescue analgesic consumption (morphine) in the first 24 hours postoperatively.	Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is = 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40.	First 24 hours postoperatively.
Secondary	The degree of postoperative pain	Postoperative pain will be assessed by Visual Analog scale (VAS) on admission to Post-Anesthesia Care unit (PACU) and at 30 minutes and then 1,2,4,6,12,18 and 24 hours postoperative.; VAS (0-100; where 0 represents no pain and 100 represents the worst pain).	First 24 hours postoperatively.
Secondary	Time to first rescue analgesia request.	Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is = 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40.	First 24 hours postoperatively.
Secondary	Intraoperative fentanyl consumption.	Additional boluses of fentanyl 0.5 µg /kg will be administered in case of inadequate analgesia that defined as increase of heart rate (HR) and /or mean arterial blood pressure (MAP) more than 20 % from baseline	Intraoperative