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

NCT06246292 | Completed

• 1 other identifier: IRB number: 00012098
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Block

Keywords

Nerve block; breast surgery; analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• To compare the dermatomal block spread in both groups

  30 minutes after regional block procedure.

• To compare the analgesic effectiveness in both groups

  The first 24 hours postoperatively at 1, 3, 6, 12, and 24 hours.

• To compare the technique-related complications in both groups

  During the regional block procedure.

• To compare the analgesic effectiveness in both groups

  The first 24 hours postoperatively.

• To compare the analgesic effectiveness in both groups

  intra- and 24 hours postoperatively

Study Arms (2)

landmark guided ESPB technique

EXPERIMENTAL

The ESPB was performed using the landmarks described by Vadera et al. (5). Before initiating the block procedure, the spinous process of the T4 vertebra and a point situated 3 cm to its side are marked at the appropriate level. The needle was inserted perpendicularly to the skin and advanced in all planes until it contacts the vertebra's transverse process. The depth at which the thoracic vertebra's transverse process lies from the skin can vary, ranging from 2 to 4 cm, contingent upon the individual's physique. The needle tip was positioned between the erector spinae muscle and the transverse process. The volume of local anesthetics was injected in this plane.

Procedure: Anatomical landmark-guided ESPB

ultrasound-guided ESPB technique

ACTIVE COMPARATOR

The block was performed based on the original description by Forero et al. (2). A high-frequency linear transducer (MyLab 70 Xvision, Esaote SpA, Florence, Italy) was positioned in the parasagittal plane 2 cm lateral to the T4 vertebra. Once the transverse process and the overlying erector spinae muscle were visible on the ultrasound, the needle was introduced using the in-plane technique. The needle was inserted in the cranial-to-caudal direction until it reached the tip of the transverse process. Following a negative aspiration and a successful hydro dissection, the local anesthetic solution was injected beneath the erector spinae muscle's fascia.

Procedure: Ultrasound-guided ESPB

Interventions

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.

ultrasound-guided ESPB technique

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.

landmark guided ESPB technique

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

faculty of medicine, Alexandria Unverisity

Alexandria, 21521, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Islam elbardan, Dr.

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 7, 2024
• Study Start: February 10, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-01

Locations

EG (1)