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Erector Spinae Plane Block in Scoliotic Adolescents

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: NCT03968146
Recruitment Status : Completed
First Posted : May 30, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
maged gamal, Kasr El Aini Hospital

Brief Summary:
For scoliotic surgeries, Erector Spinae Plane Block (ESPB) can add to the multimodal approach for perioperative pain management with decreasing the opioids requirement, improving recovery and decreasing ICU stay.

Condition or disease Intervention/treatment Phase
Scoliosis Idiopathic Scoliosis; Adolescence Erector Spinae Plane Block Procedure: Erector Spinae Plane Block Drug: Fentanyl Drug: additional Fentanyl Drug: Morphine Drug: rescue Morphine Drug: pethidine Drug: Ketorolac Drug: Acetaminophen Phase 2

Detailed Description:

All patients will be assessed clinically and investigated for Pulmonary function test and Echocardiography. 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) and liver function tests.

an online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the two study groups. Random allocation numbers will be concealed in opaque closed envelops.participants and those assessing/analyzing the outcome(s) will be blind to group assignment.

Eutectic Mixture of Local Anesthetics (EMLA) cream will be applied to the site of venous puncture. After insertion of venous access, all children will receive midazolam at a dose of 0.1 mg/Kg. Intraoperative monitoring will include continuous electrocardiogram (ECG), pulse oximetry, invasive arterial blood pressure, end-tidal carbon dioxide (CO2), inhaled gas analyzer and temperature monitoring.

General anesthesia will be induced in both groups (Erector Spinae group and control group) using propofol 2.5 mg/kg over 20-30 seconds, atracurium 0.5 mg/kg to facilitate endotracheal intubation and fentanyl 1 µg/kg. Anesthesia will be maintained using isoflurane (1 MAC) and atracurium infused as 0.5 mg/kg/hr. All patients will receive IV ranitidine 2 mg/kg, ondansetron 0.1 mg/kg, cefotaxime 50 mg/kg and acetaminophen 15 mg/kg. An arterial catheter and a urinary catheter will be placed. Then patients will be turned to the prone position.

In group E: will receive Erector Spinae Plane Block (ESPB) In group C: control group will receive another dose of fentanyl 1 µg/kg 1 minute before start of skin incision. After end of surgery and emergence from anesthesia, patients will receive continuous intravenous morphine with 0.03 mg/kg/hr.

In both groups, if the analgesia obtained from both methods of ESBP or IV fentanyl was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg). Total blood loss, duration of surgery, number of vertebral levels fixed, total fentanyl consumed will be recorded. After completion of surgical procedure and emergence from anesthesia the patient will be referred to post-anaesthesia care unit (PACU). Quality of analgesia will be assessed immediately postoperative and then at 4, 8, 12, 16, and 24 hours postoperatively in the Intensive Care Unit (ICU) by using VAS pain score. All patients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours, ketorolac from second day 15 mg q 6 hours, not to exceed 5 days. Patients will also receive ranitidine 2 mg/kg q 12 hours. Vital signs and urinary output will be monitored. Morphine IV will be given as rescue analgesia (20 µg/kg) in all study groups if visual analogue scale (VAS) pain score more than 3. The total maximum hourly morphine is 0.75 mg/kg/hr. After reaching maximum hourly morphine and the patient is still in pain, pethidine will be used as a rescue at 0.5 mg/kg. Morphine will be stopped if maximum hourly dose is reached or the patient becomes sedated (Ramsay score >2), has a ventilatory rate of <12 bpm, or an oxygen saturation of <95%, or has a serious adverse event (allergy, hypotension, severe vomiting).

Patients will be continuously monitored in the PACU and ICU. Naloxone and full resuscitation equipment are available. Time of first need for morphine and total 24 hr morphine consumption will be recorded. Complications e.g nausea, vomiting, pruritis or respiratory depression will be recorded.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Ultrasound Guided Erector Spinae Plane Block in Scoliotic Adolescents Undergoing Posterior Spine Instrumentation . A Randomized Controlled Trial
Actual Study Start Date : June 18, 2019
Actual Primary Completion Date : November 5, 2019
Actual Study Completion Date : December 2, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Fentanyl

Arm Intervention/treatment
Active Comparator: Group E
patients will receive Erector Spinae plane block in addition to intravenous fentanyl
Procedure: Erector Spinae Plane Block
The linear multi-frequency 6-13 megahertz transducer will be used. In the prone position,under aseptic conditions, the probe will be placed in a longitudinal position 2-3 cm lateral to the vertebral column. The transverse processes of the vertebrae at (mid) level of surgery, the Erector Spinae muscle and the psoas muscle are identified. A 22 gauge echogenic needle will be inserted in an in plane technique in a cephalad to caudad direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, A test dose of 5% dextrose in water can expand the fascial plane and confirm needle-tip location prior to injection of local anaesthetic. Then, 0.5 ml/kg of bupivacaine 0.25% with 0.1 mg/kg dexamethasone and adrenaline 1 : 200000 will be injected between erector spinea muscle and transverse process, taking in consideration not exceeding the toxic dose of bupivacaine; 4 mg/kg . the same procedure will be repeated on the contralateral side.

Drug: Fentanyl
patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg).
Other Name: fentanyl for induction and maintenance

Drug: rescue Morphine
Morphine IV will be given as rescue analgesia (20 µg/kg) in all study groups if VAS pain score more than 3. The total maximum hourly morphine is 0.75 mg/kg/hr.

Drug: pethidine
After reaching maximum hourly morphine and the patient is still in pain, pethidine will be used as a rescue at 0.5 mg/kg.

Drug: Ketorolac
patients will receive IV ketorolac from the postoperative second day 15 mg q 6 hours, not to exceed 5 days.

Drug: Acetaminophen
patients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours

Group C
Control group will receive only intravenous fentanyl.
Drug: Fentanyl
patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg).
Other Name: fentanyl for induction and maintenance

Drug: additional Fentanyl
patients will receive another dose of fentanyl 1 µg/kg 1 minute before start of skin incision.

Drug: Morphine
After end of surgery and emergence from anesthesia, patients will receive continuous intravenous morphine with 0.03 mg/kg/hr.
Other Name: morphine infusion

Drug: rescue Morphine
Morphine IV will be given as rescue analgesia (20 µg/kg) in all study groups if VAS pain score more than 3. The total maximum hourly morphine is 0.75 mg/kg/hr.

Drug: pethidine
After reaching maximum hourly morphine and the patient is still in pain, pethidine will be used as a rescue at 0.5 mg/kg.

Drug: Ketorolac
patients will receive IV ketorolac from the postoperative second day 15 mg q 6 hours, not to exceed 5 days.

Drug: Acetaminophen
patients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours




Primary Outcome Measures :
  1. Total morphine consumption [ Time Frame: the first 24 hours post-operative period. ]
    Total postoperative rescue morphine consumption in mg/kg for each group in the first 24 hours post-operative period.


Secondary Outcome Measures :
  1. Total fentanyl consumption [ Time Frame: intraoperative period ]
    Total intraoperative fentanyl consumption in mcg/kg for each group.

  2. Visual Analogue Scale [ Time Frame: the first 24 hours post-operative period. ]
    the visual analogue scale (VAS) is for Pain assessment It is a * total 10 cm * linear scale for pain it ranges from minimum ( 0 for no pain at all ) to maximum ( 10 for the worst pain imaginable ) higher number values indicate worst outcome. For example, as the patient mark the scale nearer to maximum, this indicate more severe pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American society of Anesthesia classification (ASA) I-II
  • Patients undergoing dorsal spine instrumentation for scoliosis.

Exclusion Criteria:

  • Refusal of block.
  • Bleeding tendency with prothrombin concentration PC less than 75 % or platelet count less than 150,000/µL.
  • Skin lesion, wounds or infection at the puncture site.
  • Known allergy to local anaesthetic drugs.

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): NCT03968146


Locations
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Egypt
Cairo University Hospitals
Cairo, Egypt
Sponsors and Collaborators
Kasr El Aini Hospital

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Responsible Party: maged gamal, anethesia demonstrator, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03968146    
Other Study ID Numbers: N-15-2019
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Acetaminophen
Ketorolac
Ketorolac Tromethamine
Fentanyl
Meperidine
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action