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Completed

NCT Number: NCT06936852

Ultrasound Guided Serratus Posterior Superior Intercostal Plane Versus PECS II Block In Breast Surgeries

The aim of the study is to compare the analgesic effect of ultrasound guided serratus posterior superior intercostal plane (SPSIP) block and pectoral nerve (PECS II) block in different breast surgeries.

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Key information

Age range

21 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Select, 1234, Egypt

About this study

All patients will be seen in the anesthesia clinic, optimization of general condition and all required investigations will be done before surgery. Patients will be premedicated with 1.5 mg midazolam and 4 mg granisetron. Standard basic monitoring will be applied to all patients then after adequate preoxygenation, induction of general anesthesia will be done through wide bore cannula using 1 mic/kg fentanyl, 1-2 mg/kg titration of propofol, 0.5mg/kg atracurium. Patients were mechanically ventilated using volume-controlled ventilation (VCV) with adjustment of end tidal carbon dioxide (ETCO2) to be 32-35 mmHg, 50% inspired oxygen in air and sevoflurane concentration to be 1MAC. The patients will receive either block before skin incision that will be done 20 minutes after the block. 0.5 mic/kg fentanyl will be injected when heart rate or blood pressure increases more than 20% of baseline. By the end of the surgery, 1gm paracetamol will be administered with fully reversal of muscle relaxants at the end of the surgery.

SPSIP group After induction of anesthesia, patients will be placed in lateral decubitus position, the affected arm will be adducted and medially rotated. Under complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs. The structures from superficial to deep are skin, subcutaneous, trapezius, rhomboid, serratus posterior superior and intercostal muscles. The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.

PECS II group With the patient in supine position, the ipsilateral upper arm will be abducted and externally rotated. Under complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep. The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.

After extubation, the patients will be transferred to PACU (Post-Anesthesia Care Unit) for monitoring. Numerical rating scale (NRS) will be used for pain assessment while 0 is no pain and 10 is severe agonizing pain. Patients will be given a rescue analgesia of 0.05 mg / kg morphine if NRS ≥ 4 and repeated if needed. Intravenous 1 gm paracetamol every 8 h and 30 mg ketorolac (if not contraindicated) every 12 h will be given regularly.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age from 21 to 70 years.
  • American Society of Anesthesiologists (ASA) Physical Status Classification System I-II.

Exclusion criteria

  • Any patient refuses to participate.
  • Bleeding or coagulation disorders, hepatic dysfunction, psychiatric diseases.
  • Chronic opioid use.
  • Patients with pulmonary diseases.
  • History of allergy to local anesthetics.
  • Infection at the needle entry point will be excluded.

Treatment and study plan

Serratus Posterior Superior Intercostal Plane Block

Procedure

Under complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs. The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.

PECS II block

Procedure

. Under complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep. The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.

Primary outcomes

  1. Total morphine consumption

    Time frame: first postoperative 24 hour

    Total morphine consumption in first postoperative twenty four hour

  2. Bedside forced vital capacity at 2 hours after surgery

    Time frame: Two hours after surgery

    Three measurements were taken and the highest one was recorded

Secondary outcomes

  1. NRS pain scores for breast and axilla when reaching recovery room arrival, after 2 hour, 6 hour, 12 hour, 18 hour, 24 hour at rest and during arm movement

    Time frame: when reaching recovery room (average 10 minutes after surgery), after two, six, twelve, eighteen, twenty four hour

    NRS when reaching recovery room, after 2 hour, 6 hour, 12 hour, 18 hour, 24 hour

  2. Time to first rescue opioid dose

    Time frame: 24 hours after surgery

    Morphine given for pain scores more than or equal to 4

  3. Incidence of chronic pain at 3 and 6 months after surgery

    Time frame: 6 months after surgery

    Any pain with score more than 3 is considered positive for chronic pain

  4. Block related complications and side effects

    Time frame: 24 hours after surgery

    Vomiting, bradycardia, hypotension, and pneumothorax will be recorded

  5. Bedside forced vital capacity at 6 and 24 hours after surgery

    Time frame: 24 hours after surgery

    Three measurements were taken and the highest one was recorded

  6. Additional intraoperative fentanyl consumption

    Time frame: during surgery

    Additional intraoperative fentanyl consumption which not used during induction

  7. Heart rate and mean arterial blood pressure

    Time frame: baseline and during surgery

    • Heart rate and mean arterial blood pressure

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Ultrasound Guided Serratus Posterior Superior Intercostal Plane Block Versus Pectoral Nerve (PECS II) Block For Pain Control In Breast Surgeries: A Randomized Comparative Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Jun 3, 2026

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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