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NCT Number: NCT05427292

Combination of Serratus Anterior and Pectoral Nerve Blocks (PECS II) as Main Anesthetic Method in Breast Cancer Surgery

Aim of this study is to determine the success of combined serratus anterior and PECS-2 block as the main anesthetic method in breast cancer surgery and also to investigate the patient acceptability of this combination and its relationship with surgeon satisfaction.

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Key information

Conditions

Anesthesia

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Samsun University, Samsun, Ilkadım, Turkey (Türkiye)

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About this study

Breast conserving surgery or mastectomy is applied in the surgical treatment of breast cancer. Axillary interventions range from sentinal lymph node biopsy to lymph node dissection. Clinically significant acute pain develops following breast surgery in 35% of patients.

Today, regional anesthesia is widely used as an opioid-sparing strategy in the treatment of acute postoperative pain. New fascial plane blocks have been developed as alternative or complementary techniques for chest wall analgesia, including pectoral nerve blocks (PECS1-2) and serratus plane block.

In order to reduce the risk of perioperative morbidity and mortality and to meet the patient demand, the demand for awake surgery is increasing in institutions.

Therefore, a prospective observational case series was conducted to explain the efficacy, patient acceptability, and surgeon satisfaction of combined serratus anterior and PECS-2 block as the main anesthetic method for breast cancer surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients between the ages of 18-80 and ASA I-III who will undergo unilateral breast cancer surgery will be included in the study.

Exclusion criteria

  • Patients with previous breast surgery other than excisional biopsy,
  • coagulopathy,
  • bleeding disease,
  • local infection at the injection site,
  • history of local anesthetic allergy,
  • psychiatric disease (depression, mania, schizophrenia or antipsychotic drug use),
  • history of opioid use for more than 4 weeks
  • Patients with body mass index (BMI) >40kg/m2 and
  • chest deformity (pectus excavatum and pectus carinatum) will be excluded from the study.

Treatment and study plan

serratus anterior block and PECs II block combination

Other

The pre-surgery block will be applied. Sensorial block will be evaluated at the surgical incision site with the pinpirick test at 30 minutes after the block, and if the block is successful, surgery will begin.

Primary outcomes

  1. Sufficient surgical anesthesia

    Time frame: up to 30 minutes

    After confirming the sensory block in the surgical area with the post-procedure pinpirick test, successful completion of the surgical procedure 'without the need for deep sedoanalgesia' will be considered 'sufficient surgical anesthesia'.

Secondary outcomes

  1. Pain scores on the Numeric Rating Scale (NRS)

    Time frame: up to 24 hours

    Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  2. Quality of recovery 15 scale

    Time frame: up to 24 hours

    Postoperative Quality of Recovery 15 in Turkish scale

  3. analgesic consumption

    Time frame: up to 24 hours

    In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected

  4. modified Wilson Sedation Scale

    Time frame: up to 2 hours

    • Oriente, eyes may be closed, but says his name, answers where he is
    • Sleepy, eyes may be closed, can be warned when called by name
    • Can be stimulated by mild physical stimulation (earlobe)
    • Cannot be stimulated by mild physical stimulation

  5. quality of anesthesia

    Time frame: up to 2 hours

    Are you satisfied with the anesthesia? Would you like to have surgery with the same technique again? Would you recommend it to others?

    • Extremely satisfied,
    • Satisfied,
    • Neither satisfied nor dissatisfied,
    • Not satisfied,
    • It will be calculated by responding as highly dissatisfied.

  6. scaling working conditions

    Time frame: up to 2 hours

    Working conditions scaling

    Indistinguishable from general anesthesia A little challenging/enough It will be determined by choosing one of the overly challenging/inadequate options.

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

Feasibilty of Serratus Anterior and Pectoral Nerve Blocks (PECS II) Combination as Main Anesthetic Method in Breast Cancer Surgery Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 22, 2022
Registry last updated
Jul 10, 2023

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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