Effectiveness of Bilateral Ultrasound-Guided Erector Spinae Plane Block

Early Phase 1

Completed

• Conditions: Erector Spinae Plane Block
• Interventions: Drug: Morphine Consumption; Drug: Bilateral Ultrasound-Guided Erector Spinae Plane Block

• Registration Number: NCT04110210
• Lead Sponsor: Cairo University

Brief Summary

The proposed mechanism of action of the ESPB is via blockade of the dorsal and ventral rami of the spinal nerves and sympathetic nerve fibers. Radiographic evidence suggests that local anesthetic injected into at the ESP spreads both cranially and caudally as the plane is continuous along the vertebral column . ESPB reportshave demonstrated analgesia at cervical, thoracic, and lumbar levels for procedures such aspyeloplasty, lipoma excision, breast reconstruction,malignant mesothelioma, inguinal hernia repairs, and hip reconstructions

Detailed Description

One of these local analgesia is the erector spinae plane block (ESPB). it was first described in 2016 as a regional block for the treatment of thoracic neuropathic pain. This has shown promise as an alternative to neuraxial blockade for a variety of surgeries with good effect. In addition, the block has a reduced risk of epidural hematoma, direct spinal cord injury, and central infection .

The proposed mechanism of action of the ESPB is via blockade of the dorsal and ventral rami of the spinal nerves and sympathetic nerve fibers. Radiographic evidence suggests that local anesthetic injected into at the ESP spreads both cranially and caudally as the plane is continuous along the vertebral column . ESPB reportshave demonstrated analgesia at cervical, thoracic, and lumbar levels for procedures such aspyeloplasty, lipoma excision, breast reconstruction,malignant mesothelioma, inguinal hernia repairs, and hip reconstructions

Study Timeline

• Study First Submitted: 2019-03-15
• Study Start: 2019-09-08
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-10-01
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-10
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Patients aged from 18 to 60 years.
• Genders eligible for study: both sexes.
• ASA I-II.
• Undergoing lumbar spine surgeries in any 2 levels(L1-L5).
• BMI from 18.5 to 30 kg/m2

Exclusion Criteria

• Patient refusal
• Contraindications to regional anesthesia (Bleeding disorders, Use of any anti-coagulants, local infection, etc.).
• Known allergy to local anesthetics.
• ASA III-IV.
• Patients aged less than 18 or more than 60.
• Body mass index >35.
• Patients with difficulty in evaluating their level of pain.
• Patients with secondary surgery or surgery involving more than two intervertebral spaces were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B(GA with conventional analgesia)	Morphine Consumption	After operation, patients will be transferred to post anesthesia care unit (PACU) for complete recovery and monitoring. The pain VAS scores between the studied groups will be registered every 4 hours for 24 hours postoperatively. A standard postoperative analgesia regimen will be prescribed as paracetamol 1gm every 6 hours and ketorolac 30mg every 8 hours in the first 24 hours postoperatively. Morphine 2.5 mg will be given as a rescue analgesic dose if visual analogue score was ≥ 3 or when patient suffering from pain between the assessment intervals in both groups not exceeding 0.1 mg/kg in a period of 6 hours. Metoclopramide 0.15 mg/kg IV will be prescribed for patients complaining of nausea or vomiting.
Group A(Ultrasound guided ESP block after indtiucon of GA).	Bilateral Ultrasound-Guided Erector Spinae Plane Block	Following skin sterilization and local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle is inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact was made with the transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle is confirmed by injecting 0.5-1 ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total of 20ml bupivacaine 0.25% are then injected into the ESP. The procedure is repeated on the contralateral side.

Primary Outcome Measures

Name	Time	Method
Intraoperative and postoperative Opiate consumption	Up to 24 hours	Intraoperative fentanyl and postoperative morphine consumption

Secondary Outcome Measures

Name	Time	Method
Block onset	Up to 24 hours	Onset of the block
Time of the first postoperative analgesic request .	Up to 24 hours	Time of the first postoperative analgesic request (duration of the block).
Visual Analouge score	Up to 24 hours	Visual Analouge score score postoperative where 0=No Pain (better outcome) and 10=Intractable Pain (worse outcome)

Trial Locations

Locations (1)

Ahmed Abdalla Mohamed; 🇪🇬 Cairo, Egypt