AzTrials
AzTrials

Retrolaminar BlockNCT04336111

Ultrasound Guided Bilateral Retrolaminar Block as Analgesia for Adolescent Idiopathic Scoliosis Correction

A study testing retrolaminar block in people with Retrolaminar Block and Analgesia, run by Tanta University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 10 to 65 years
Conditions the study is for
Retrolaminar Block, Analgesia, Adolescent
What is being tested?
retrolaminar block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteEgypt
Study dates
30 Dec 2023to 10 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with idiopathic adolescent scoliosis undergoing surgical correction

Who cannot join

  • Bleeding disorders (coagulopathy).
  • Mental dysfunction.
  • History of allergy to local anesthetics.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • tarek Abdel Lattif

    Tanta

    tarek Abdel Lattif, MD, 01003591332, dr.tarek311@yahoo.com

    Recruiting

Other trials in Egypt

About this study

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

Read the 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: -

  1. Demographic data.
  2. Time of the first dose of rescue analgesia (morphine at dose of 0.1 mg/kg).
  3. Total doses of postoperative morphine consumption.
  4. Number of patients received rescue analgesia.
  5. 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.
  6. Total doses intraoperative consumption of fentanyl.
  7. 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).
  8. First time of postoperative mobilization.
Being tested
retrolaminar block
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • retrolaminar blockProcedure or surgery

    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.

Study groups in NCT04336111
Study groupRoleWhat they receive
control groupNo interventionwill receive sham bilateral bilevel ultrasounded guided retrolaminar block at T4 and T10 after induction of anaesthesia in prone position.
retrolaminar blockExperimentalwill 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.
Receives: Procedure: retrolaminar block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to first analgesic request

    time to first analgesic request

    Measured: within 24 hrs postoperative

Secondary outcomes (2)
  1. intraoperative fentanyl consumption

    intraoperative fentanyl consumption

    Measured: intraoperative

  2. postoperative morphine consumption

    postoperative morphine consumption

    Measured: within 24 hrs postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2020
  2. Study start30 Dec 2023
  3. Primary completion31 Mar 2024
  4. Study completion10 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04336111
Sponsor's protocol ID
retrolaminar block
Status last verified
Apr 2024
First submitted
3 Apr 2020
Last updated
15 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing retrolaminar block in people with Retrolaminar Block and Analgesia, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to first analgesic request (time frame: within 24 hrs postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in