Clinical trial 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.
Official title: Erector Spinae Plane Block: Anatomical Landmark Versus Ultra-sounded Guided Technique, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Keywords: Nerve block
breast surgery
analgesia
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 248
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To compare the success rate of both landmark-guided ESPB and ultrasound-guided ESPB techniques for analgesia in breast surgery
timeFrame: 30 minutes after regional block procedure
Secondary outcomes:
measure: To compare the dermatomal block spread in both groups
timeFrame: 30 minutes after regional block procedure.
measure: To compare the analgesic effectiveness in both groups
timeFrame: The first 24 hours postoperatively at 1, 3, 6, 12, and 24 hours.
measure: To compare the technique-related complications in both groups
timeFrame: During the regional block procedure.
measure: To compare the analgesic effectiveness in both groups
timeFrame: The first 24 hours postoperatively.
measure: To compare the analgesic effectiveness in both groups
timeFrame: intra- and 24 hours postoperatively
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: faculty of medicine, Alexandria Unverisity
Study officials:
affiliation: University of Alexandria
name: Islam elbardan, Dr.
role: PRINCIPAL_INVESTIGATOR
References: