Serratus Anterior Plane Block Versus Erector Spinae Plane Block With Dexmedetomidine Added to Bupivacaine for Ultrasound-Guided Pain Management After Mastectomy

Not Applicable

Completed

• Conditions: Serratus Anterior Plane Block; Erector Spinae Plane Block; Dexmedetomidine; Bupivacaine; Ultrasound; Pain Management; Mastectomy
• Interventions: Drug: Bupivacaine + Dexmedetomidine

• Registration Number: NCT06737458
• Lead Sponsor: Kafrelsheikh University

Brief Summary

This study aimed to compare the serratus plane block versus the erector spinae plane block with dexmedetomidine added to bupivacaine for acute pain management after breast surgeries.

Detailed Description

Approximately 40-60% of breast surgery patients endure severe acute postoperative pain, with over 10% of patients experiencing severe pain for six to twelve months (post-mastectomy pain syndrome).

Dexmedetomidine has analgesic properties, which could be related to the stimulation of α2 adrenoceptors, inhibition of nerve conduction through C and Aδ fibers, and the local release of encephalin.

Serratus plane block (SPB) is an effective approach for breast surgery analgesia due to its simplicity of delivery, minimal risk of adverse effects, and ability to provide significant pain relief.

The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB can be given unilaterally during modified radical mastectomy.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Women aged >20 years.
• Patient's approval.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Patients underwent breast surgeries.

Exclusion Criteria

• Known allergy to local anesthetics, opioids, or dexmedetomidine medications.
• Advanced heart block, ventricular dysfunction.
• Skin infection at the site of injection.
• Pre-existing chronic pain.
• Coagulopathies, significant liver or renal insufficiency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serratus anterior plane block group	Bupivacaine + Dexmedetomidine	Patients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.
Erector spinae plane block group	Bupivacaine + Dexmedetomidine	Patients received erector spinae plane block at T5 on the operated side and will receive bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.

Primary Outcome Measures

Name	Time	Method
Total dose of pethidine consumption	24 hours postoperatively	Patients get 1 g paracetamol IV like clockwork. Salvage absence of pain as bolus IV pethidine at 0.5 mg/kg was managed if NRS \> 3

Secondary Outcome Measures

Name	Time	Method
Intraoperative fentanyl consumption	Intraoperatively	In case the cruel blood vessel weight (Outline) or heart rate (HR) went over 20% of pattern values, additional bolus dosages of 0.5 µg/kg IV fentanyl were given.
Heart rate	Every 15 minutes until the end of the surgery (Up to 2 hours)	Heart rate was measured preoperatively and intraoperatively every 15 minutes until the end of the surgery.
Mean arterial pressure	Every 15 minutes until the end of the surgery (Up to 2 hours)	Mean arterial pressure was measured preoperatively and intraoperatively every 15 minutes until the end of the surgery.
Degree of pain	24 hours postoperatively	Each patient was instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS was assessed at post anesthesia care unit, 1, 2, 6, 12, 18, and 24 hours postoperatively
Incidence of complications	24 hours postoperatively	Incidence of complications such as hypotension, bradycardia, and postoperative nausea and vomiting (PONV) were recorded.

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt