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Erector Spinae Block Versus Local Field Block in Lumbar Spine Surgeries

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Erector spinae plane block
local field block
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring postoperative pain, Erector spinae plane block, lumbar spine surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients 18-65 years old.
  • Patients undergoing Lumbar spine surgery (L1-L5).
  • American society of anesthesiologists classification (ASA) I and II.
  • BMI < 35
  • Duration of surgery less than 3 hours

Exclusion Criteria:

  • Patient's refusal.
  • Bleeding disorders (platelets count < 150,000; INR >1.5; PC< 60%) and coagulopathies.
  • Skin lesion, wounds or infection at the injection site.
  • Known allergy to local anesthetic drugs.
  • Chronic opioid users.
  • Patients with pre-operative opioid consumption.
  • Patients on long term therapy of Corticosteroids

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Erector spinae plane group

    local field block

    Arm Description

    The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of L3. a curvilinear ultrasound transducer will be placed sagittal 3 cm lateral to L3 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 20 mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected. The procedure will be repeated following the same steps on the other side. The surgical intervention will be then allowed 20 minutes after finishing the block procedure

    For the preincisional local field block, a 23-gauge needle is used to infiltrate 20mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected in the subcutaneous space and in the paravertebral muscles on each side of the spinous processes of the presumed surgical approach.

    Outcomes

    Primary Outcome Measures

    duration of postoperative analgesia
    Time to first analgesic request

    Secondary Outcome Measures

    cumulative 24 hour opioid consumption
    the amount of Nalbuphine consumed by the patient in the first 24 hours postoperative
    pain assessment using VAS score at 15minutes, 30 minutes,1,2,4,8,12,24 hours postoperative
    The visual analog scale(VAS) score is a validated,subjective measure for acute and chronic pain, scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and"worst pain".
    presence of any complications
    bradycardia,hypotension, arrythmia
    patient satisfaction with anesthesia
    11 point score , where 0=unsatisfied and 10=most satisfied
    surgeon satisfaction for surgical field accessibility
    likert 5 point scale, where 1=very unsatisfied and 5=vry satisfied

    Full Information

    First Posted
    October 3, 2022
    Last Updated
    October 4, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05570565
    Brief Title
    Erector Spinae Block Versus Local Field Block in Lumbar Spine Surgeries
    Official Title
    Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Preincisional Local Field Block for Perioperative Analgesia in Lumbar Spine Surgeries; Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    January 2023 (Anticipated)
    Study Completion Date
    January 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Major lumbar spine surgeries are associated with significant postoperative pain that may last for days,So In this study, we intend to evaluate if preventive analgesia with a single injection dose of ultrasound guided bilateral erector spinae is a safe and better method of peri-operative analgesia for lumbar spine surgeries than preincisional local field block.
    Detailed Description
    Patients scheduled for lumbar spine surgery will be recruited and a written informed consent will be obtained from patients. All patients will be assessed clinically and investigated for exclusion of any of the above mentioned contraindications. Laboratory work needed will be: Complete blood count (CBC); prothrombin time and concentration (PT& PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT) , liver function tests and kidney function tests . ● Operating Room preparation & Equipment: The ultrasound used will be curvilinear high-frequency ultrasound transducer (Siemens acuson x300 3-5 MHz ultrasound) • Methods: General anaesthesia will be induced. 1.5 μg/kg fentanyl based on lean body weight with maximum dose of 200 μg and 2 mg/kg propofol will be given based on total body weight. Tracheal intubation will be facilitated with 0.5 mg/kg atracurium based on ideal body weight. Volume controlled ventilation will be adjusted to maintain normocapnia . Anesthesia will be maintained by using 1.5% isoflurane in a mixture of oxygen and air (50/50) and atracurium top ups at a dose of 0.1mg/kg every 30 minutes. Patients will be placed in the prone position on a Relton Hall frame or padded bolsters. In group (A): local field block For the preincisional local field block, a 23-gauge needle is used to infiltrate 20mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected in the subcutaneous space and in the paravertebral muscles on each side of the spinous processes of the presumed surgical approach. In group (B): Bilateral Ultrasound guided Erector spinae group. The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of L3. a curvilinear high-frequency ultrasound transducer will be placed sagittal 3 cm lateral to L3 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 20 mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected. The procedure will be repeated following the same steps on the other side. The surgical intervention will be then allowed 20 minutes after finishing the block procedure. All participants will be given 1 gram of intravenous paracetamol with maximum dose of 4 gm every 24 hour, together with 4 mg ondansetron 10 min prior to the end of surgery for postoperative nausea and vomiting prophylaxis. Failed block (increase in HR and mean arterial blood pressure (MABP)>20% from base line with skin incision) will be treated by 0.5 ug/kg of fentanyl as top-up doses and increasing isoflurane concentration in case of inadequate response to fentanyl. After skin closure , the patient will be turned to supine position,then inhalational anesthesia will be discontinued and reversal of muscle relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be administered intravenous after return of patient's spontaneous breathing .the patient will be extubated awake, Patients will then be transferred to post anesthesia care unit (PACU) for 60 min to complete recovery and monitoring. At any time hypotension (defined as a decrease in mean arterial pressure (MAP) >25% from baseline value or systolic arterial pressure (SAP <100 mmHg)) will be treated with 5 mg IV bolus ephedrine and repeated every 3 minutes until the hypotension resolved. Bradycardia (HR <50 beats per minute) will be treated with atropine 0.5 mg IV. Rescue analgesia : Intra operative: 0.5ug /kg of fentanyl as top-up doses at any time if blood pressure and heart rate increased by more than 20% from baseline reading . Post-operative : In the PACU ; VAS will be assessed 15 minutes after extubation and if the score is exceeding 4/10 , rescue analgesia in the form of Nalbuphine 0.1mg/kg will be given .another dose of Nalbuphine 0.1mg/kg can be given in the PACU if the score still more than 4 after 30 minutes of the 1st dose. After discharging from the PACU; the analgesic plan will be intravenous paracetamol 1gm every 8hours and ketorolac 0.5mg/kg/6hours as a standard regimen , Nalbuphine 0.1mg/kg will be given as rescue analgesia on demand or at any time if VAS score exceeding 4(maximum 20mg per dose and 160mg in 24 hours)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    postoperative pain, Erector spinae plane block, lumbar spine surgery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Erector spinae plane group
    Arm Type
    Experimental
    Arm Description
    The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of L3. a curvilinear ultrasound transducer will be placed sagittal 3 cm lateral to L3 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 20 mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected. The procedure will be repeated following the same steps on the other side. The surgical intervention will be then allowed 20 minutes after finishing the block procedure
    Arm Title
    local field block
    Arm Type
    Active Comparator
    Arm Description
    For the preincisional local field block, a 23-gauge needle is used to infiltrate 20mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected in the subcutaneous space and in the paravertebral muscles on each side of the spinous processes of the presumed surgical approach.
    Intervention Type
    Procedure
    Intervention Name(s)
    Erector spinae plane block
    Intervention Description
    ultrasound guided injection of local anesthestics drugs (mixture of lidocaine and bupivacaine) in the Erector spinae plane which lies between the Erector spinae muscle and lumbar transverse process
    Intervention Type
    Procedure
    Intervention Name(s)
    local field block
    Intervention Description
    infiltration of local anesthestic drugs( mixture of lidocaine and bupivacaine) in the surgical field before surgical incision
    Primary Outcome Measure Information:
    Title
    duration of postoperative analgesia
    Description
    Time to first analgesic request
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    cumulative 24 hour opioid consumption
    Description
    the amount of Nalbuphine consumed by the patient in the first 24 hours postoperative
    Time Frame
    24 hours
    Title
    pain assessment using VAS score at 15minutes, 30 minutes,1,2,4,8,12,24 hours postoperative
    Description
    The visual analog scale(VAS) score is a validated,subjective measure for acute and chronic pain, scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and"worst pain".
    Time Frame
    24 hours
    Title
    presence of any complications
    Description
    bradycardia,hypotension, arrythmia
    Time Frame
    evey 10 minutes intraoperative till end of surgery (up to 2 hours)
    Title
    patient satisfaction with anesthesia
    Description
    11 point score , where 0=unsatisfied and 10=most satisfied
    Time Frame
    24 hours
    Title
    surgeon satisfaction for surgical field accessibility
    Description
    likert 5 point scale, where 1=very unsatisfied and 5=vry satisfied
    Time Frame
    2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients 18-65 years old. Patients undergoing Lumbar spine surgery (L1-L5). American society of anesthesiologists classification (ASA) I and II. BMI < 35 Duration of surgery less than 3 hours Exclusion Criteria: Patient's refusal. Bleeding disorders (platelets count < 150,000; INR >1.5; PC< 60%) and coagulopathies. Skin lesion, wounds or infection at the injection site. Known allergy to local anesthetic drugs. Chronic opioid users. Patients with pre-operative opioid consumption. Patients on long term therapy of Corticosteroids
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdelmoneim A Abdelmoneim, lecturer
    Phone
    01004392046
    Ext
    202
    Email
    abdelmoneim_adel@kasralainy.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohamed A Elshazly, lecturer
    Phone
    01016109777
    Ext
    202
    Email
    DR.mohamed.elshazly8686@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abdelmoneim A Abdelmoneim, lecturer
    Organizational Affiliation
    Anesthesia department , cairo university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Erector Spinae Block Versus Local Field Block in Lumbar Spine Surgeries

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