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Effectiveness of Bilateral Ultrasound-Guided Erector Spinae Plane Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110210
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Abdalla, 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

Condition or disease Intervention/treatment Phase
Erector Spinae Plane Block Drug: Bilateral Ultrasound-Guided Erector Spinae Plane Block Drug: Morphine Consumption Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Care Provider)
Masking Description: Prospective randomized double blinded clinical study on humans
Primary Purpose: Diagnostic
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
Actual Study Start Date : September 8, 2019
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: 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.
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Intraoperative and postoperative Opiate consumption [ Time Frame: Up to 24 hours ]
    Intraoperative fentanyl and postoperative morphine consumption


Secondary Outcome Measures :
  1. Time of the first postoperative analgesic request . [ Time Frame: Up to 24 hours ]
    Time of the first postoperative analgesic request (duration of the block).

  2. Visual Analouge score [ Time Frame: Up to 24 hours ]
    Visual Analouge score score postoperative where 0=No Pain (better outcome) and 10=Intractable Pain (worse outcome)

  3. Block onset [ Time Frame: Up to 24 hours ]
    Onset of the block



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110210


Locations
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Egypt
Ahmed Abdalla Mohamed
Cairo, Egypt, 11451
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Abdalla Mohamed, M.D Cairo University
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Responsible Party: Ahmed Abdalla, Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT04110210    
Other Study ID Numbers: MD-80-2019
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Still Working

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents