Effectiveness of Bilateral Ultrasound-Guided Erector Spinae Plane Block

NCT04110210 | Completed Early Phase 1 DMC

• 1 other identifier: MD-80-2019
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

• Intraoperative and postoperative Opiate consumption

  Intraoperative fentanyl and postoperative morphine consumption

  Up to 24 hours

Secondary Outcomes (3)

• Time of the first postoperative analgesic request .

  Up to 24 hours

• Visual Analouge score

  Up to 24 hours

• Block onset

  Up to 24 hours

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Drug: Bilateral Ultrasound-Guided Erector Spinae Plane Block

Group B(GA with conventional analgesia)

ACTIVE COMPARATOR

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.

Drug: Morphine Consumption

Interventions

Bilateral Ultrasound-Guided Erector Spinae Plane Block 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 A(Ultrasound guided ESP block after indtiucon of GA).

Morphine Consumption 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.

Group B(GA with conventional analgesia)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

Study Officials

• Ahmed Abdalla Mohamed, M.D

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Prospective randomized double blinded clinical study on humans
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: October 1, 2019
• Study Start: September 8, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 10, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-07

Locations

EG (1)