Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06947642

Ultrasound-guided Pectoral Nerve Blocks, Thoracic Erector Spinae Plane Block and Serratus Anterior Plane Block for Breast Surgery

The study will compare ultrasound-guided Pectoral nerve block, Erector Spinae Plane block, and Serratus anterior plane block for pain management following elective breast surgeries

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Ashraf E Alzftawy, MD

SUB_INVESTIGATOR

Attia G Ibrahim, MD

SUB_INVESTIGATOR

Nashwa E Hamoda, MD

SUB_INVESTIGATOR

Rehab S Taha, Master

CONTACT

[email protected]

00201000507975

Sabry M Amin, MD

SUB_INVESTIGATOR

About this study

Adequate acute postoperative pain control is important for patients undergoing breast surgery because the pain may be severe and longlasting. Surgical incision at the breast and axillary areas is associated with significant pain, with high incidence of acute pain progressing to chronic pain in 25% to 60% of patients. Post-mastectomy pain managed with opioids often lead to side effects of nausea and vomiting.

Regional anesthetic techniques are used in the current management of pain associated with breast surgeries .They attenuate surgical stress response , intraoperative consumption of opioid, prevent central sensitization and diminish postoperative pain.

The efficacy of fascial plane blocks like pectoral nerve block (PECS), serratus anterior plane block (SAP), and erector spinae plane block (ESP) has been proven in previous studies. These blocks require deposition of local anesthetic in an inter-fascial plane through which peripheral nerves travel.

The Pectoral nerve block relies upon the deposition the local anesthetic at the inter-fascial planes among the pectoralis major, minor, and serratus anterior muscles: it blocks the pectoral, the intercostobrachial, the intercostals III and VI, and the long thoracic nerves.

Erector Spinae Plane block is another interfacial plane block. It involves deposition of local anesthetic between erector spinae muscle and transverse process of T5 vertebrae and targets both dorsal and ventral rami of thoracic spinal nerves.

Serratus anterior plane block involves the injection of local anesthetic in 1 of the 2 fascial planes, superficial and deep to serratus anterior muscle at the level of the fifth rib in midaxillary line. The SAP block targets the lateral cutaneous branches of the thoracic intercostal nerves. The deep SAP block was found to have similar analgesic efficacy and technically easier and safer to perform as compared to the superficial SAP block.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 21 to 65 years old female, American Society of Anesthesiologists (ASA) physical status I or II, who will undergo breast surgeries under general anesthesia.

Exclusion criteria

  • Patient refusal to participate in research.
  • Body Mass Index (BMI) ≥35 kg/m2.
  • Sensitivity to the intervention drugs.
  • Coagulation abnormalities.
  • Psychiatric disorder and communication difficulties.
  • Chronic neurological disease.
  • Any skin infection at the needle puncture site.
  • Chest wall deformity

Treatment and study plan

Pectoral nerve block (PECS)

Drug

Patients will receive pectoral nerve block (PECS).

Other names: Bupivacaine 0.25

Erector spinae plane block (ESP)

Drug

Patients will receive erector spinae plane block (ESP).

Other names: Bupivacaine 0.25

Serratus anterior plane block (SAP)

Drug

Patients will receive serratus anterior plane block (SAP).

Other names: Bupivacaine 0.25

Primary outcomes

  1. Total morphine consumption

    Time frame: 24 hours postoperatively

    Rescue analgesia of morphine will be given as 3 mg bolus if the visual analogue scale (VAS) ≥ 4 to be repeated after 30 min if pain persists until the VAS< 4.

Secondary outcomes

  1. Time to the 1st rescue analgesia

    Time frame: 24 hours postoperatively

    Time to 1st request for the rescue of analgesia (time from the end of surgery till first dose of morphine administrated) will be recorded.

  2. Intraoperative fentanyl consumption

    Time frame: Intraoperatively

    Intraoperative fentanyl consumption will be recorded.Additional fentanyl bolus dosages of 0.5 µg/kg IV will be administered if mean arterial blood pressure and heart rate elevated more than 20% of the baseline (after exclusion of other causes).

  3. Pain degree

    Time frame: 24 hours postoperatively

    Each patient will be instructed about postoperative pain assessment with the visual analogue scale (VAS) (20), from 0 to 10 (0 represents "no pain" while 10 represents "the worst pain imaginable").Rescue analgesia of morphine will be given as 3 mg bolus if the VAS ≥ 4 to be repeated after 30 min if pain persists until the VAS< 4. VAS will be assessed at 30min, 2, 6,12 and 24 h postoperatively

  4. Mean arterial blood pressure

    Time frame: Till the end of surgery (Up to 24hours)

    Intraoperative hemodynamic parameters: Mean arterial blood pressure (MAP) will be recorded at baseline, after performing of block, and every 15 min till the end of surgery.

  5. Heart rate

    Time frame: Till the end of surgery (Up to 24hours)

    Intraoperative hemodynamic parameters: Heart rate (HR) will be recorded at baseline, after performing of block, and every 15 min till the end of surgery.

  6. Patient satisfaction

    Time frame: 24 hours Postoperatively

    Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)

  7. Adverse effects

    Time frame: 24 hours Postoperatively

    bradycardia, hypotension, nausea, vomiting, respiratory depression, hematoma at the site of injection, local anesthetic toxicity will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Rehab S Taha, Master

CONTACT

[email protected]

00201000507975

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparison Between Ultrasound-guided Pectoral Nerve Blocks, Thoracic Erector Spinae Plane Block and Serratus Anterior Plane Block for Breast Surgery: A Prospective Randomized Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2025
Registry last updated
May 20, 2025

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.

Published trials that share one or more normalized conditions with this study.