Effectiveness of Bilateral Ultrasound-Guided Erector Spinae Plane Block

NCT ID: NCT04110210

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-08
• Study Completion Date: 2020-07-10

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

Conditions

Erector Spinae Plane Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Group A(Ultrasound guided ESP block after indtiucon of GA).

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.

Group Type: ACTIVE_COMPARATOR

Bilateral Ultrasound-Guided Erector Spinae Plane Block

Intervention Type: DRUG

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.

Group B(GA with conventional analgesia)

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 Type: ACTIVE_COMPARATOR

Morphine Consumption

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdalla

Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Abdalla Mohamed, M.D

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Ahmed Abdalla Mohamed

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MD-80-2019

Identifier Type: -

Identifier Source: org_study_id