Efficacy of Serratus Anterior Plane Block With Dexmedetomidine During Breast Surgery

Analgesia Clinical Trial

Official title:

Efficacy of Single Level Versus Bilevel Serratus Anterior Plane Block With Dexmedetomidine During Breast Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05361837
• Other study ID #: AP2204-50104
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: August 25, 2024

Study information

• Verified date: May 2024
• Source: National Cancer Institute, Egypt
• Contact: Walaa Y Elsabeeny, MD
• Phone: 201007798466
• Email: walaa.elsabeeny[@]nci.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare single level serratus block versus bilevel serratus block with and without dexmedetomidine in cancer patients undergoing modified radical mastectomy for breast cancer regarding pain control and possible side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: August 25, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients scheduled for modified radical mastectomy,

• Age 18-65 years,

• ASA I-II

Exclusion Criteria:

• patient refusal,

• coagulation defects,

• abnormal kidney or liver functions,

• local infection at site of injection.

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• Single level serratus anterior plane block
Serratus anterior plane block with local anesthetics at the third rib
• Single level serratus anterior plane block with dexmedetomidine
Serratus anterior plane block with local anesthetics and dexmedetomidine at the third rib
• Bilevel serratus anterior plane block
Serratus anterior plane block with local anesthetics at the third and fifth rib
• Bilevel serratus anterior plane block with dexmedetomidine
Serratus anterior plane block with local anesthetics and dexmedetomidine at the third and fifth rib

Locations

Country	Name	City	State
Egypt	Walaa Y Elsabeeny	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First time to receive analgesia	first time to receive morphine analgesia in hours	First 24 hours postoperatively
Primary	Total analgesic requisite	total amount of morphine consumption in the first 24 hours postoperatively in mg	First 24 hours postoperatively
Secondary	Pain scores	pain scores will be assessed using Visual Analogue Scale on a sale from 0 to 10 with 0 meanung no pain and 10 meaning severe pain	First 24 hours postoperatively
Secondary	Side effects	nausea and vomiting and hematoma at site of injection	First 24 hours postoperatively
Secondary	Perioperative heart rate values	heart rate values in the form of beat per minute in the perioperative period including preoperative, intraoperative and postoperative	First 24 hours
Secondary	Mean arterial blood pressure	Mean arterial blood pressure values in the form mmHg in the perioperative period including preoperative, intraoperative and postoperative	First 24 hours