The Efficacy and Safety of Landmark-guided Compared to Ultrasound-guided Erector Spinae Plane Block Techniques for Analgesia in Female Patients After Breast Surgery.

Erector Spinae Plane Block: Anatomical Landmark Versus Ultra-sounded Guided Technique, a Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06246292

Enrollment

248

Registered

2024-02-07

Start date

2024-02-10

Completion date

2024-07-01

Last updated

2024-07-30

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

Conditions

Nerve Block

Keywords

Nerve block, breast surgery, analgesia

Brief summary

The erector spinae plane (ESP) block is a technique that helps alleviate acute pain. It involves injecting local anesthetic between the erector spinae muscle (ESM) and the vertebra's transverse process (TP). This technique can be guided by ultrasound or anatomical landmarks, and it can be performed while the patient is lying down, sitting or on their side.

Detailed description

Ultrasound guidance has established itself as the norm for regional anesthesia procedures, enabling live visualization of anatomical structures and enhancing the precision and safety of needle insertion. Conversely, the blind technique relies on anatomical landmarks and the ability to palpate to direct needle insertion. Although the blind technique might provide simplicity and efficiency, uncertainties persist concerning its precision and possible associated risks. As the popularity of the ESPB increases, a relevant query emerges: Should it be conducted with ultrasound guidance or through a non-guided technique? This study was designed to validate the efficacy and safety of a landmark-guided ESPB technique compared to an ultrasound-guided ESPB technique for analgesia in breast surgery. The hypothesis was that the ultrasound and anatomical landmark techniques for ESPB would provide equivalent analgesia. The study's primary objective was to compare the success rate of both techniques. The secondary objectives were to compare the dermatomal block spread, analgesic effectiveness, and technique-related complications.

Interventions

PROCEDUREUltrasound-guided ESPB

The ESPB is a truncal block guided by ultrasound, involving the injection of local anesthetic beneath the erector spinae muscle (ESM), positioned between the ESM and the transverse process (TP) of the vertebra.

PROCEDUREAnatomical landmark-guided ESPB

The ESPB is a truncal block guided by anatomical landmarks, involving the injection of local anesthetic beneath the erector spinae muscle (ESM), positioned between the ESM and the transverse process (TP) of the vertebra.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged 18 years or older. * Patients had an American Society of Anesthesiology (ASA) physical score of I-II. * Patients undergoing unilateral elective breast surgery.

Exclusion criteria

* Patients had a contraindication to an ESPB (including coagulopathy, recent anticoagulant medication usage, or infection at the needle puncture site). * Patients had a history of opioid addiction, preoperative opioid use, and allergies to study medications. * Obesity (body mass index exceeding 35 kg/m²). * If the placement of ESPB was not completed due to technique difficulties. * Patients who expressed a lack of willingness to participate in the study were not considered eligible for participation.

Design outcomes

Primary

Measure	Time frame	Description
To compare the success rate of both landmark-guided ESPB and ultrasound-guided ESPB techniques for analgesia in breast surgery	30 minutes after regional block procedure	The primary outcome was the binary outcome: therapeutic success or failure of ESPB techniques in achieving cutaneous sensory block for breast surgery (from T1 to T6).

Secondary

Measure	Time frame	Description
To compare the dermatomal block spread in both groups	30 minutes after regional block procedure.	Assessment of the number of blocked cutaneous sensory dermatomes from T1 to T10.
To compare the analgesic effectiveness in both groups	The first 24 hours postoperatively at 1, 3, 6, 12, and 24 hours.	Assessment of rest visual analog score (VAS) for surgical site pain (0 -10) 2.
To compare the technique-related complications in both groups	During the regional block procedure.	Assessment of occurrence of adverse effects.

Countries

Egypt

Outcome results

None listed

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