Efficacy of Serratus Anterior Plane Block With Dexmedetomidine During Breast Surgery

Not Applicable

Recruiting

• Conditions: Analgesia
• Interventions: Procedure: Single level serratus anterior plane block with dexmedetomidine; Procedure: Bilevel serratus anterior plane block with dexmedetomidine; Procedure: Single level serratus anterior plane block; Procedure: Bilevel serratus anterior plane block

• Registration Number: NCT05361837
• Lead Sponsor: National Cancer Institute, Egypt

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-05
• Study Start: 2022-05-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-12
• Last Update Posted: 2024-05-14
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 172

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single level serratus anterior plane block with dexmedetomidine	Single level serratus anterior plane block with dexmedetomidine	the allocated patients will receive single injection serratus anterior plane block at the level of third rib with local anesthetics and dexmedetomidine
Bilevel serratus anterior plane block with dexmedetomidine	Bilevel serratus anterior plane block with dexmedetomidine	the allocated patients will receive injection serratus anterior plane block at 2 levels, the level of third rib and the level of the fifth rib with local anesthetics and dexmedetomidine
Single level serratus anterior plane block	Single level serratus anterior plane block	the allocated patients will receive single injection serratus anterior plane block at the level of third rib with local anesthetics only
Bilevel serratus anterior plane block	Bilevel serratus anterior plane block	the allocated patients will receive injection serratus anterior plane block at 2 levels, the level of third rib and the level of the fifth rib with local anesthetics only

Primary Outcome Measures

Name	Time	Method
First time to receive analgesia	First 24 hours postoperatively	first time to receive morphine analgesia in hours
Total analgesic requisite	First 24 hours postoperatively	total amount of morphine consumption in the first 24 hours postoperatively in mg

Secondary Outcome Measures

Name	Time	Method
Pain scores	First 24 hours postoperatively	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
Side effects	First 24 hours postoperatively	nausea and vomiting and hematoma at site of injection
Perioperative heart rate values	First 24 hours	heart rate values in the form of beat per minute in the perioperative period including preoperative, intraoperative and postoperative
Mean arterial blood pressure	First 24 hours	Mean arterial blood pressure values in the form mmHg in the perioperative period including preoperative, intraoperative and postoperative

Trial Locations

Locations (1)

Walaa Y Elsabeeny; 🇪🇬 Cairo, Egypt