Effectiveness of Bilateral Ultrasound-Guided Erector Spinae Plane Block

Erector Spinae Plane Block Clinical Trial

Official title:

Effectiveness of Bilateral Ultrasound-Guided Erector Spinae Plane Block in Intraoperative and Postoperative Pain Control in Lumbar Spine Surgeries.A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04110210
• Other study ID #: MD-80-2019
• Status: Completed
• Phase: Early Phase 1
• Start date: September 8, 2019
• Est. completion date: July 10, 2020

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 10, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erector Spinae Plane Block

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Ahmed Abdalla Mohamed	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative and postoperative Opiate consumption	Intraoperative fentanyl and postoperative morphine consumption	Up to 24 hours
Secondary	Time of the first postoperative analgesic request .	Time of the first postoperative analgesic request (duration of the block).	Up to 24 hours
Secondary	Visual Analouge score	Visual Analouge score score postoperative where 0=No Pain (better outcome) and 10=Intractable Pain (worse outcome)	Up to 24 hours
Secondary	Block onset	Onset of the block	Up to 24 hours