Ultrasound Guided Bilateral Retrolaminar Block as Analgesia for Adolescent Idiopathic Scoliosis Correction
Primary Purpose
Retrolaminar Block, Analgesia, Adolescent
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
retrolaminar block
Sponsored by
About this trial
This is an interventional other trial for Retrolaminar Block
Eligibility Criteria
Inclusion Criteria:
- Patients with idiopathic adolescent scoliosis undergoing surgical correction
Exclusion Criteria:
- Bleeding disorders (coagulopathy).
- Mental dysfunction.
- History of allergy to local anesthetics.
Sites / Locations
- tarek Abdel LattifRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
retrolaminar block
Arm Description
will receive sham bilateral bilevel ultrasounded guided retrolaminar block at T4 and T10 after induction of anaesthesia in prone position.
will receive real bilateral bilevel ultrasounded guided retrolaminar block at T4 and T10 after induction of anaesthesia in prone position. The total desired volume used in the whole injection will be 40 ml containing 3mg / kg bupivacaine with adrenaline 2.5 2 µg/ml. The total 40 ml volume will be divided into 10 ml for each injection.
Outcomes
Primary Outcome Measures
time to first analgesic request
time to first analgesic request
Secondary Outcome Measures
intraoperative fentanyl consumption
intraoperative fentanyl consumption
postoperative morphine consumption
postoperative morphine consumption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04336111
Brief Title
Ultrasound Guided Bilateral Retrolaminar Block as Analgesia for Adolescent Idiopathic Scoliosis Correction
Official Title
Ultrasound Guided Bilateral Retrolaminar Block as Analgesia for Adolescent Idiopathic Scoliosis Correction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 4, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta 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
Scoliosis is a structural, tridimensional deformity of the spine. Characterized by lateral curvature and rotation of the vertebrae with functional limitations and cosmetic problems, idiopathic scoliosis, which accounts for 75% to 80% of all scoliosis, is the most common of all types. (1, 2) Surgical treatment is an effective way to correct severe spine deformity when the deformity progressively worsens and cannot be positively corrected by brace treatment. Spinal correction surgery is one of the most invasive surgical procedures and usually results in moderate to severe levels of postoperative pain. (3) Severe pain may induce implant complications such as construct dislodgement, broken instrumentation, and implant loosening which requires additional revision procedures These conditions adversely affect postoperative outcomes.(4) In the past several years, pain has become an important indicator for evaluating indicators of outcome and quality of life after surgery. Effective analgesia after surgery could improve patients' prognosis.(5) The retrolaminar block is a recently described ultrasound-guided technique in which local anesthetics is injected into the fascial plane between the posterior surface of the thoracic lamina and the overlying transverso-spinalis muscles. (2) The available evidence indicates that retrolaminar block is effective in reducing opioid requirements and improving the pain experience in a wide range of clinical settings. They are best employed as part of multimodal analgesia with other systemic analgesics
Detailed Description
-Preoperative: Evaluation of patients will be carried out through proper history taking, clinical examination and routine laboratory investigation and patients will be trained to use the Numerical Rating Scale (NRS 0= no pain, 10= intolerable pain) used for evaluation of pain intensity.
The patient is allowed to fast for 8 hours for solids and 2h for clear fluid. Before the study, all patients will be interviewed and will be briefed on the wake-up test procedure. They will be informed that they will be asked to open their eyes, move their fingers (hold the anesthesiologist's hand), move their toes, and finally, to remember a given color.
-Intraoperative: On arrival to operating roome, a 20 G peripheral IV cannula will be inserted. Electrocardiogram (ECG), noninvasive mean arterial blood pressure (MAP) and peripheral oxygen saturation will be attached and baseline data will be monitored and documented. Sedation will be given intravenously in the form of midazolam 0.02 mg/kg and IV fliud according to calculation of deficit and maintaince calculation.
After preoxygenation, anesthesia with IV propofol 2 mg/ kg and fentanyl 2 µg/kg will be administered for analgesia and cisatracurium 0.5 mg/ kg will be given intravenously to facilitate endotracheal intubation.
Central venous catheter will be inserted and attached for monitoring of CVP. Also, enotropy will be connected on the patientꞌs forehead and maintained between 40-60.
44 patients will be equally divided to two equal groups (22 patients for each group) Group 1: will receive sham bilateral bilevel ultrasounded guided retrolaminar block at T4 and T10 after induction of anaesthesia in prone position.
Group 2: will receive real bilateral bilevel ultrasounded guided retrolaminar block at T4 and T10 after induction of anaesthesia in prone position. The total desired volume used in the whole injection will be 40 ml containing 3mg / kg bupivacaine with adrenaline 2.5 2 µg/ml. The total 40 ml volume will be divided into 10 ml for each injection.
Maintaince of anaesthesia will be 50 : 50 % O2 to air and sevoflurane 2% and cisatracurium incremental every 30 min at dose of 0.1 mg/kg. I.V analgesia in form of incremental fentanyl 1 ug /kg when entropy increases more than 60 during surgery and 30 min before the wake-up test.
Wake up test: Before continuation of anesthesia, patients will be given a color to remember. After finishing the wake-up test, anesthesia will be induced using 3 mg/kg propofol and 0.1 mg/kg cisatracurium, whereas anesthesia will be maintained as described previously.
At the end of surgery, inhalational anesthetic agent will be turned off, residual neuromuscular block will be reversed with neostigmine 0.05 mg/kg and atropine 0.01 mg/kg then patients will be extubated and will be transferred to post anesthesia care unit (PACU).
Postoperative multimodal analgesia: will received paracetamol 10 mg/kg every 6 hours and intravenous diclofenac 1.5 mg/kg every 8 hours regularly.
All observations will be carried out by a single investigator, who is blinded to the study groups.
-In all groups, the following will be measured: -
Demographic data.
Time of the first dose of rescue analgesia (morphine at dose of 0.1 mg/kg).
Total doses of postoperative morphine consumption.
Number of patients received rescue analgesia.
Numerical Rating Scale (NRS) for pain that ranged from (0 = no pain) to (10 = intolerable pain). If score is >3 will need analgesia in the form of morphine 0.1 mg/kg will be given till NRS decreases to ≤3. NRS will be assessed and recorded on arrival to the Recovery Unit, 2, 4, 8, 12, 18, 24 h after the operation, by an anesthesiologist, who is blinded to the study groups.
Total doses intraoperative consumption of fentanyl.
Wake-up profile: On the surgeons' request for the intraoperative wake-up test, administration of sevoflurane will be stopped. (the quality of wake-up, return of spontaneous breathing, ability to open eyes on command, and ability to move hands and feet) and postoperative amnesia. Patients will be asked repeatedly during the wake-up test, at least every 15 s, to open their eyes and to move their hands and feet. The time elapsed from the interruption of anesthesia to the start of spontaneous breathing (T1), from the return of spontaneous breathing to eye opening on command (T2), and from eye opening to movement of hands and feet (T3) will be recorded in seconds using a stopwatch. The quality of the wake-up test will be evaluated on a three-point rank scale (7).
First time of postoperative mobilization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retrolaminar Block, Analgesia, Adolescent, Idiopathic Scoliosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
will receive sham bilateral bilevel ultrasounded guided retrolaminar block at T4 and T10 after induction of anaesthesia in prone position.
Arm Title
retrolaminar block
Arm Type
Experimental
Arm Description
will receive real bilateral bilevel ultrasounded guided retrolaminar block at T4 and T10 after induction of anaesthesia in prone position. The total desired volume used in the whole injection will be 40 ml containing 3mg / kg bupivacaine with adrenaline 2.5 2 µg/ml. The total 40 ml volume will be divided into 10 ml for each injection.
Intervention Type
Procedure
Intervention Name(s)
retrolaminar block
Intervention Description
will receive real bilateral bilevel ultrasounded guided retrolaminar block at T4 and T10 after induction of anaesthesia in prone position. The total desired volume used in the whole injection will be 40 ml containing 3mg / kg bupivacaine with adrenaline 2.5 2 µg/ml. The total 40 ml volume will be divided into 10 ml for each injection.
Primary Outcome Measure Information:
Title
time to first analgesic request
Description
time to first analgesic request
Time Frame
within 24 hrs postoperative
Secondary Outcome Measure Information:
Title
intraoperative fentanyl consumption
Description
intraoperative fentanyl consumption
Time Frame
intraoperative
Title
postoperative morphine consumption
Description
postoperative morphine consumption
Time Frame
within 24 hrs postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with idiopathic adolescent scoliosis undergoing surgical correction
Exclusion Criteria:
Bleeding disorders (coagulopathy).
Mental dysfunction.
History of allergy to local anesthetics.
Facility Information:
Facility Name
tarek Abdel Lattif
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tarek Abdel Lattif, MD
Phone
01003591332
Email
dr.tarek311@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Ultrasound Guided Bilateral Retrolaminar Block as Analgesia for Adolescent Idiopathic Scoliosis Correction
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