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Ultrasound Guided Serratus Anterior Plane Block Versus Ultrasound Guided Thoracic Epidural Analgesia

Ultrasound Guided Serratus Anterior Plane Block Versus Ultrasound Guided Thoracic Epidural Analgesia for Conservative Breast Surgery: A Comparative Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07807605
Enrollment
70
Registered
2026-09-08
Start date
2023-01-10
Completion date
2023-06-10
Last updated
2026-09-08

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

Conditions

Breast Cancer

Brief summary

Regional/local analgesic techniques are an important component of a multimodal analgesic strategy, with the aim of reducing opioid requirements and opioid-related adverse events. This change parallels quality improvement initiatives and the Enhanced Recover after Surgery. Breast conserving surgery with radiation therapy is today standard therapy for low grade breast cancer. It is safe and preferred therapeutic procedure in all early detected breast cancers ,because it provide the same level of overall survival rates as seen in patients treated with mastectomy ,have been found by several prospective and randomized studies and number of clinical trials .

Detailed description

Acute post-surgical pain leads to delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic persistent post-operative pain in almost half of the patients. Post-operative pain, stress and use of morphine have been elucidated as factors responsible for increased risk of metastasis. Hence, an effective perioperative pain management of patients undergoing breast surgery is essential. Regional blocks have been considered as one of the modalities for effective perioperative pain control. They have an opioid-sparing effect, and allow early mobilisation and early discharge from hospital. Ultrasound-guided muscle plane blocks have changed the practice of regional anesthesia for breast surgeries. Different variations of Pecs block have been described with an aim to provide anesthesia and analgesia of the hemi thorax. Recently described serratus anterior plane (SAP) block was designed to target primarily the thoracic intercostal nerves, providing complete analgesia to the lateral part of the thorax. Compared with Pecs-II, the needle is placed more caudally and posteriorly in SAP block and local anesthetic (LA) is deposited either superficial or deep to the serratus anterior muscle. Serratus Anterior Plane (SAP) block has been described recently as injection of local Anesthetic (LA) in mid axillary line at the level of the 5th rib either superficial or deep to the serratus anterior (SA) muscle. The intention is to block the thoracic intercostal nerves to provide complete analgesia of the lateral part of the chest. There are some clinical reports validating its use in breast surgeries. Although serratus anterior plane (SAP) block affects the long thoracic nerve of bell supplying serratus anterior (SA) but there is no mention of blocking the thoracodorsal nerve supplying latissmus dorsi (LD).The thoracodorsal nerve is the sole nerve that supplies latissmus dorsi (LD) and forms a plexus between serratus anterior (SA)and latissmus dorsi (LD). On the other hand, regarding thoracic epidural analgesia, the results from MRI studies indicate that the spinal cord lies anteriorly within its thecal sac in the thoracic curve and the following measures were found: 5.19 mm in T2, 7.75 mm in T5 and 5.88 mm in T10, this let us say, sufficient distance to permit the careful advancement of a needle (accidentally or intentionally) without reaching the cord and administer anesthetic for a segmental spinal anesthesia. This anatomical explanation was proposed for the absence of spinal cord injury during an accidental perforation during attempted thoracic epidural.

Interventions

DRUGBupivacaine 0.25% Injectable Solution

to compare and evaluate safety, efficacy, benefits and complications of thoracic epidural analgesia and serratus anterior plane block in patients undergoing Conservative breast surgery under general anesthesia.

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* patients of the American Society of Anesthesiology physical status (І and ІІ) Female patients. * Female patients diagnosed with breast malignancy * Patients with Body weight: patients with body mass index less than 35.

Exclusion criteria

* Uncooperative patient, those with any contraindication for spinal or epidural anesthesia (systemic coagulopathy-local infection) * Patients with body mass index \>35 * Patients with chronic obstructive pulmonary disease * Patients with anatomic abnormalities * Patients with allergy to study drugs

Design outcomes

Primary

MeasureTime frameDescription
Post Operative Painfrom 2 hous till 24 hours after the surgerythe duration of effective analgesia from the block till the first analgesic dose is required.the severity of postoperative pain as assessed by the visual analogue scale ((0 = no pain, 10 = most imaginable pain) at 1, 4, 8, 12, and 24 hours after the completion of the surgery.

Countries

Egypt

Contacts

STUDY_CHAIRMahmoud Attia Ali, Professor

Anesthesiology,Surgical intensive care & pain management,Faculty of Medicine,Beni-Suef University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026