Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date December 3, 2019
Actual Study Start Date  ICMJE June 18, 2019
Actual Primary Completion Date November 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Total fentanyl consumption [ Time Frame: intraoperative period ]
    Total intraoperative fentanyl consumption in mcg/kg for each group.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • Total fentanyl consumption [ Time Frame: intraoperative period ]
    Total intraoperative fentanyl consumption in mcg/kg for each group.
  • Pain assessment score [ Time Frame: the first 24 hours post-operative period. ]
    In the Post Anesthesia Care Unit and Intensive Care Unit, patient will be asked to fulfill a questionnaire during the first 24 hours post-operative period using the visual analogue scale (VAS) for Pain assessment score which is a 10-cm linear analogue scale for pain, ranged from 0 for no pain at all to 10 for the worst pain imaginable.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Erector Spinae Plane Block in Scoliotic Adolescents
Official Title  ICMJE Ultrasound Guided Erector Spinae Plane Block in Scoliotic Adolescents Undergoing Posterior Spine Instrumentation . A Randomized Controlled Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Scoliosis Idiopathic
  • Scoliosis; Adolescence
  • Erector Spinae Plane Block
Intervention  ICMJE
  • 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: 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
Study Arms  ICMJE
  • Active Comparator: Group E
    patients will receive Erector Spinae plane block in addition to intravenous fentanyl
    Interventions:
    • Procedure: Erector Spinae Plane Block
    • Drug: Fentanyl
    • Drug: rescue Morphine
    • Drug: pethidine
    • Drug: Ketorolac
    • Drug: Acetaminophen
  • Group C
    Control group will receive only intravenous fentanyl.
    Interventions:
    • Drug: Fentanyl
    • Drug: additional Fentanyl
    • Drug: Morphine
    • Drug: rescue Morphine
    • Drug: pethidine
    • Drug: Ketorolac
    • Drug: Acetaminophen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2, 2019
Actual Primary Completion Date November 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03968146
Other Study ID Numbers  ICMJE N-15-2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party maged gamal, Kasr El Aini Hospital
Study Sponsor  ICMJE Kasr El Aini Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kasr El Aini Hospital
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP