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s Serratus Anterior Block for Perioperative Analgesia

Ultrasound-Guided Erector Spinae Block Versus Serratus Anterior Block for Perioperative Analgesia In Patients Undergoing Modified Radical Mastectomy Surgery

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06410378
Enrollment
75
Registered
2024-05-13
Start date
2024-05-10
Completion date
2024-08-01
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mastectomy, Postoperative Pain

Keywords

Erector Spinae Block, Serratus anterior Block, Perioperative Analgesia

Brief summary

Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimised, as in a number of women it may chronically persist for months in the form of postmastectomy pain syndrome. Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques as paravertebral block and thoracic epidural anathesia has possible complications and technical difficulties. The new alternative regional techniques such as erector spinae plane block and serratus anterior plane block are clinical trials for providing a safe, easy and painless anesthetic procedure with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opiods consumption and subsequently avoid opiod-related adverse effects.

Detailed description

Breast cancer is the most common malignancy of women all over the world. Unfortunately, two-thirds of women who undergo breast cancer surgery are reported to develop chronic pain in the postoperative period. Surgery type, radiation therapy, and clinically acute pain are the most important risk factors for the development of more intense chronic pain. With improved diagnostic techniques and treatment regimens, prognosis in breast cancer is improving, with the 5-year survival of patients diagnosed with primary breast cancer having increased to approximately 85%. Persistent post-surgical pain states in this group is reported in 30-50% of patients, up to half of whom may have pain well beyond 5 years. Over one-third of patients who underwent breast cancer surgery have inadequately controlled acute post-operative pain. There are several ways to manage pain after mastectomy. Common systemic medications, particularly opioids, have different side effects, such as itching, nausea, vomiting and respiratory depression. Non-steroidal anti-inflammatory drugs are associated with impaired renal function and hemorrhagic disorders. Regional anesthesia has been believed as one of the formats for effective perioperative pain control. Regional blocks using ultrasound-guide has become a perfect supplement to general anesthesia for extending analgesia after modified radical mastectomy. The advantage includes post-operative pain relief prolongation, a decrease in analgesic requirement post-operatively, a reduction in nausea and vomiting scores and probability for ambulatory discharge and hospital stay. The complex innervation of breast tissues poses a great challenge for the anesthesiologists to provide adequate perioperative analgesia by ultrasound guided regional blocks. Thoracic epidural, interscalene brachial plexus block, paravertebral block, pectoral nerve I and pectoral nerve II blocks have been used in different studies with good results. There are also technically simple regional blocks as ultrasound-guided Serratus anterior Plane (US-guided SAP) block and erector spinae plane (US-guided ESP) block which can be used effectively for this purpose. Forero et al. described ultrasound-guided Erector Spinae Plane (US-ESP) block as a novel analgesic technique in which local anesthetic injection is done beneath the erector spinae muscle. Previous studies reported effective postoperative pain reduction with ESP block after radical mastectomy surgery. Nevertheless, few studies have compared the efficacy of ESP block with another block technique. The Serratus Anterior Plane block (SAP) provides anterolateral and partial posterior thoracic wall analgesia, affecting dermatomes from T2 to T9. SAP is affecting predominantly the lateral cutaneous branches of the thoracic intercostal nerves, along with intercostobrachial, thoracodorsal and long thoracic nerves. The block is performed further posteriorly and caudally than Pectoral Nerve Block-2, where the target nerves are located between the serratus anterior and the latissimus dorsi muscles.

Interventions

PROCEDUREErector Spinae Plane Block

Patient will receive 20 ml of bupivacaine 0.25 % through Erector Spinae Plane Block approach

PROCEDURESerratus Anterior Plane Block

Patient will receive 20 ml of bupivacaine 0.25 % through Serratus Anterior Plane Block approach.

patient will receive general anesthesia

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

The patients will be divided randomly by a computer-generated randomization table into three equal groups

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Written informed consent from the patient. * Age: 21 - 60 years old. * Gender: female patients. * Body mass index: \< 35 kg/m2. * Physical status: ASA grade I-II (American society of anesthiologists). * Type of operation: unilateral modified radical mastectomy operation.

Exclusion criteria

* • Patient with known history of allergy to study drugs. * Chronic use of analgesics or drug dependence. * Patients not able to understand pain assessment test. * Anatomical abnormalities. * Neuropathic disease. * Pregnancy or breast feeding. * Other contraindication of regional anesthesia e.g. septic focus at site of injection. * patient with coagulopathy or on anticoagulant therapy.

Design outcomes

Primary

MeasureTime frameDescription
time of first analgesia requirementduring 24 hours postoperativefirst time patient asks rescue analgesia and total morphine consumption post-operative.

Secondary

MeasureTime frameDescription
onset of Sensory block.within 20 minutes after blocktime needed for onset of sensory block.
assessment of sensory blockwithin 8 hours after giving blockquality and duration of block

Other

MeasureTime frameDescription
dynamic pain scoresat 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively.Visual analog scale (VAS) of 0-10, where 0= No pain and 10= Maximum worst pain.
Static pain scoresat 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively.Visual analog scale (VAS) of 0-10, where 0= No pain and 10= Maximum worst pain.

Countries

Egypt

Contacts

Primary ContactAsmaa M Galal Eldin, MD
asmaa.galal79@gmail.com01200726092
Backup Contactsara H Yousif, master
Saraheikal10@gmail.com01015051856

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026