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AnalgesiaNCT05596227

Ultrasound Guided Erector Spinae Block vs Thoracolumbar Interfascial Plane Block

A study testing Propofol, Fentanyl and Rocuronium in people with Analgesia and Lumbar Spine Disease, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aim of this Study will be to compare Ultrasound guided erector spinae block vs thoracolumbar interfascial plane (TLIP) block in lumbar spine surgeries. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Analgesia, Lumbar Spine Disease
What is being tested?
Propofol, Fentanyl and Rocuronium
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteEgypt
Study dates
20 Oct 2022to 20 Sep 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 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing lumbar spine surgery
  • American Society of Anesthesiologists (ASA) classification as ASA I-II.

Who cannot join

  • coagulation abnormality
  • anticoagulant treatment,
  • allergies to local anesthetics,
  • skin infections at the site of block area,
  • pregnancy or lactation,
  • refusal to participate in the study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mona Mohamed Mogahed

    Tanta, Elgharbia, 31511

Other trials in Egypt

About this study

Official title: Comparison Between Ultrasound Guided Erector Spinae Block vs Thoracolumbar Interfascial Plane Block in Lumbar Spine Surgeries;Randomized Controlled Trial

Aim of this Study will be to compare Ultrasound guided erector spinae block vs thoracolumbar interfascial plane (TLIP) block in lumbar spine surgeries.

Read the detailed description

A total of 180 patients who will be scheduled for single-level lumbar discectomy and laminectomy surgery under general anesthesia will be included in this trial between October 2022 to March 2023.

Inclusion criteria:

The participants will be aged between 20 and 65 years, and will be classified per the American Society of Anesthesiologists (ASA) classification as ASA I-II.

The exclusion criteria Will be a history of coagulation abnormality, anticoagulant treatment, allergies to local anesthetics, skin infections at the site of block area, pregnancy or lactation, and refusal to participate in the study.

A computer program will be used to randomize the participants into 3 groups. Each group (mTLIP block, ESPB, and control) will compose of 60 patients. All patients will be monitored with the standard ASA criteria, electrocardiography, noninvasive blood pressure, and pulse oximetry. Midazolam (2 mg) will be administered intravenously (IV) for sedation. Anesthesia induction will be performed with IV propofol (2-2.5 mg/kg), fentanyl (1-1.5 mg/kg), and rocuronium bromide (0.9 mg/ kg). The patients will be placed in the prone position following intubation. Sevoflurane will be used in a mixture of oxygen and fresh air for anesthesia maintenance. Fentanil will be administered for intraoperative analgesia according to the baseline heart rate and mean arterial pressure of the patients. The intraoperative data (heart rate, peripheral oxygen saturation, noninvasive arterial pressure, and end-tidal carbon dioxide level) will be recorded at 5-minute intervals during the operation. All patients will do lumbar spine surgery by the same surgical team using the same technique.

Block Technique After the induction of anesthesia, either the US-guided mTLIP block or ESPB will be performed in the prone position.A 22G sonovisible block needle with a length of 100 mm will be used to create a puncture. The control group will not receive any intervention. ESPB Technique. In the ESPB group, the probe will be placed in the parasagittal plane at the level of the L3 vertebrae. The spinous process will be visualized, and the probe will move 3 cm laterally from the midline. The erector spinae muscle will be visualized above the transverse process. The needle will be punctured in the craniocaudal direction using the in-plane technique. The needle will be directed superior to the transverse process. Then, 2 mL normal saline solution was injected into the deep fascia of the erector spinae muscle to confirm the proper injection site. After ensuring the location of the needle, 20 mL of 0.25% ropivacaine was administered. The same ESPB procedure will be performed on the other side. In total, 40 mL of 0.25% ropivacaine was administered. mTLIP Technique In the mTLIP group, the probe will be placed vertically at the L3 vertebrae level. The spinous process and the interspinous muscles (i.e., multifidus, longissimus, and iliocostalis) will be visualized as the anatomic guide points. The probe will move laterally to identify the longissimus and iliocostalis muscles. The needle will be inserted between the longissimus and iliocostalis in the medial-to-lateral direction using the in-plane technique. After confirming the location of the needle, 20 mL of 0.25% ropivacaine was administered. The same mTLIP procedure will be performed on the opposite side. In total, 40 mL of 0.25% ropivacaine will be administered. A dose of 1 g paracetamol and 100 mg of tramadol will be administered IV at the end of the surgery to all patients in the mTLIP, ESPB, and control groups. The patients will be extubated after exhibiting sufficient spontaneous respiration and will be transferred to the postanesthesia care unit (PACU). After they attained a modified Aldrete score of 12, the patients will be discharged from the PACU. Standard Postoperative Analgesia Protocol and Measurement of Pain. The postoperative analgesic treatment will be managed using the classic protocol of our department. At the PACU, a fentanyl patient-controlled analgesia (PCA) device will be attached to the patients. The PCA device will be prepared with the following protocol: no infusion dose, a 2-mL (10 µ/ml) bolus, a 20-minute lockout time, and a 4-hour limit of 200 mg. IV 1 g paracetamol was ordered every 6 hours postoperatively. A pain nurse anesthetist, who will be blinded to the trial, will evaluate and record the opioid consumption and the pain scores using a Visual Analog Scale (VAS; 0 = no pain, 10 = the most severe pain). Passive (at rest) and active (while mobilized) VAS scores were recorded at 2, 4, 6, 8 and16 hours during the postoperative period. If VAS was higher than or equal to 4, IV meperidine (0.5 mg/kg) will be administered as rescue analgesia within the postoperative 24-hour period. The opioid-related adverse effects (itching, nausea, vomiting, etc.) and the block procedure times will be also recorded. The block procedure time is defined as the time interval from the start of the visualization of the sonoanatomy to the injection of the local anesthetic solution.

Medical subject headings
Agnosia, Spinal Diseases

What participants receive

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

  • PropofolDrug

    Also called Intravenous anesthesia

    Induction of anesthesia will be by IV propofol (2-2.5 mg/kg)

  • FentanylDrug

    Also called Intravenous narcotic

    Fentanyl will be injected during the induction of anesthesia (1-1.5 mg/kg)

  • RocuroniumDrug

    Also called Muscle relaxant

    Rocuronium will be injected during induction of anesthesia (0.6 mg/ kg)

  • SevofluraneDrug

    Also called Inhalational anesthetic

    Sevoflurane inhalationa anesthesia will be used for maintainance of anesthesia

  • Erector spinae plane blockOther

    In the ESPB group, the probe will be placed in the parasagittal plane at the level of the L3 vertebrae. The spinous process will be visualized, and the probe will move 3 cm laterally from the midline. The erector spinae muscle will be visualized above the transverse process. The needle will be punctured in the craniocaudal direction using the in-plane technique. The needle will be directed superior to the transverse process . Then, 2 mL normal saline solution was injected into the deep fascia of the erector spinae muscle to confirm the proper injection site. After ensuring the location of the needle, 20 mL of 0.25% bupivacaine was administered. The same ESPB procedure will be performed on the other side. In total, 40 mL of 0.25% bupivacaine was administered.

  • Thoracolumbar interfascial plane blockOther

    In the mTLIP group, the probe will be placed vertically at the L3 vertebrae level. The spinous process and the interspinous muscles (i.e., multifidus, longissimus, and iliocostalis) will be visualized as the anatomic guide points. The probe will move laterally to identify the longissimus and iliocostalis muscles. The needle will be inserted between the longissimus and iliocostalis in the medial-to-lateral direction using the in-plane technique. After confirming the location of the needle, 20 mL of 0.25% bupivacaine was administered. The same mTLIP procedure will be performed on the opposite side. In total, 40 mL of 0.25% bupivacaine will be administered.

Study groups in NCT05596227
Study groupRoleWhat they receive
control groupPlacebo comparatorPatients will not recieve either erector spinae plane block nor thoracolumbar interfascial plane block
Receives: Drug: Propofol; Drug: Fentanyl; Drug: Rocuronium; Drug: Sevoflurane
Erector spinae plane blockActive comparatorPatients will recieve ultrasound guided erector spinae plane block.
Receives: Drug: Propofol; Drug: Fentanyl; Drug: Rocuronium; Drug: Sevoflurane; Other: Erector spinae plane block
Thoracolumbar interfascial plane blockActive comparatorPatients will recieve ultrasound guided thoracolumbar interfascial plane block.
Receives: Drug: Propofol; Drug: Fentanyl; Drug: Rocuronium; Drug: Sevoflurane; Other: Thoracolumbar interfascial plane block

What is being measured

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

  1. Total postoperative fentanyl requirements

    Total postoperative fentanyl requirements

    Measured: 24 hours

Secondary outcomes (3)
  1. pain score at rest and during movement

    pain score at rest and during movement using numercal rating score

    Measured: 24 hours

  2. time of first postoperative analgesic request

    time of first postoperative analgesic request

    Measured: 24 hours

  3. opioids side effects

    nausea , vomiting, respiratory depression and urine retension

    Measured: 24 hours

Timeline

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

  1. First posted27 Oct 2022
  2. Study start20 Oct 2022
  3. Primary completion20 Sep 2024
  4. Study completion20 Sep 2024

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05596227
Sponsor's protocol ID
35634/8/22
Status last verified
Nov 2024
First submitted
29 Sep 2022
Last updated
25 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Propofol, Fentanyl and Rocuronium in people with Analgesia and Lumbar Spine Disease, 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 25 Nov 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total postoperative fentanyl requirements (time frame: 24 hours). 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 25 Nov 2024.

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