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NCT Number: NCT06737458

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

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.

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Key information

Conditions

Serratus Anterior Plane Block Agnosia Bupivacaine Dexmedetomidine Erector Spinae Plane Block Mastectomy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Ultrasound

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine + Dexmedetomidine

Drug

Patients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.

Other names: Serratus anterior plane block

Primary outcomes

  1. Total dose of pethidine consumption

    Time frame: 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 outcomes

  1. Intraoperative fentanyl consumption

    Time frame: 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.

  2. Heart rate

    Time frame: 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.

  3. Mean arterial pressure

    Time frame: 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.

  4. Degree of pain

    Time frame: 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

  5. Incidence of complications

    Time frame: 24 hours postoperatively

    Incidence of complications such as hypotension, bradycardia, and postoperative nausea and vomiting (PONV) were recorded.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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