Skip to main content
OpenTrials
Completed

NCT Number: NCT06246292

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

faculty of medicine, Alexandria Unverisity

Alexandria, 21521, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Ultrasound-guided ESPB

Procedure

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.

Anatomical landmark-guided ESPB

Procedure

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.

Primary outcomes

  1. To compare the success rate of both landmark-guided ESPB and ultrasound-guided ESPB techniques for analgesia in breast surgery

    Time frame: 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 outcomes

  1. To compare the dermatomal block spread in both groups

    Time frame: 30 minutes after regional block procedure.

    Assessment of the number of blocked cutaneous sensory dermatomes from T1 to T10.

  2. To compare the analgesic effectiveness in both groups

    Time frame: 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.

  3. To compare the technique-related complications in both groups

    Time frame: During the regional block procedure.

    Assessment of occurrence of adverse effects.

  4. To compare the analgesic effectiveness in both groups

    Time frame: The first 24 hours postoperatively.

    The time (minutes) to the first intravenous patient-controlled analgesia (IV-PCA) demand dose.

  5. To compare the analgesic effectiveness in both groups

    Time frame: intra- and 24 hours postoperatively

    Total fentanyl opioid consumption (microgram).

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2024
Registry last updated
Jul 30, 2024

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.