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

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06246292
• Other study ID #: IRB number: 00012098
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 248
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nerve Block

Intervention

Procedure:
• Ultrasound-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.
• Anatomical 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.

Locations

Country	Name	City	State
Egypt	faculty of medicine, Alexandria Unverisity	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the success rate of both landmark-guided ESPB and ultrasound-guided ESPB techniques for analgesia in breast surgery	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).	30 minutes after regional block procedure
Secondary	To compare the dermatomal block spread in both groups	Assessment of the number of blocked cutaneous sensory dermatomes from T1 to T10.	30 minutes after regional block procedure.
Secondary	To compare the analgesic effectiveness in both groups	Assessment of rest visual analog score (VAS) for surgical site pain (0 -10) 2.	The first 24 hours postoperatively at 1, 3, 6, 12, and 24 hours.
Secondary	To compare the technique-related complications in both groups	Assessment of occurrence of adverse effects.	During the regional block procedure.
Secondary	To compare the analgesic effectiveness in both groups	The time (minutes) to the first intravenous patient-controlled analgesia (IV-PCA) demand dose.	The first 24 hours postoperatively.
Secondary	To compare the analgesic effectiveness in both groups	Total fentanyl opioid consumption (microgram).	intra- and 24 hours postoperatively