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.
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.
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.
- Conditions
- Analgesia, Lumbar Spine Disease
- Being tested
- Propofol, Fentanyl, Rocuronium, Sevoflurane, Erector spinae plane block
- 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 group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Patients 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 block | Active comparator | Patients 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 block | Active comparator | Patients 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.
Total postoperative fentanyl requirements
Total postoperative fentanyl requirements
Measured: 24 hours
Secondary outcomes (3)
pain score at rest and during movement
pain score at rest and during movement using numercal rating score
Measured: 24 hours
time of first postoperative analgesic request
time of first postoperative analgesic request
Measured: 24 hours
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.
- First posted27 Oct 2022
- Study start20 Oct 2022
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Mogahed, Tanta University
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound Guided Erector Spinae Block vs Thoracolumbar Interfascial Plane Block in Lumbar Spine Surgeries;Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05596227
- Acronym / sponsor ID
- 35634/8/22
- Conditions
- Analgesia, Lumbar Spine Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of this Study will be to compare Ultrasound guided erector spinae block vs thoracolumbar interfascial plane (TLIP) block in lumbar spine surgeries.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Propofol, Drug: Fentanyl, Drug: Rocuronium, Drug: SevofluranePatients will not recieve either erector spinae plane block nor thoracolumbar interfascial plane block |
| Erector spinae plane block | Active comparator | Drug: Propofol, Drug: Fentanyl, Drug: Rocuronium, Drug: Sevoflurane, Other: Erector spinae plane blockPatients will recieve ultrasound guided erector spinae plane block. |
| Thoracolumbar interfascial plane block | Active comparator | Drug: Propofol, Drug: Fentanyl, Drug: Rocuronium, Drug: Sevoflurane, Other: Thoracolumbar interfascial plane blockPatients will recieve ultrasound guided thoracolumbar interfascial plane block. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing lumbar spine surgery
- American Society of Anesthesiologists (ASA) classification as ASA I-II.
Key exclusion criteria (6 listed)
- coagulation abnormality
- anticoagulant treatment,
- allergies to local anesthetics,
- skin infections at the site of block area,
- pregnancy or lactation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: Intravenous anesthesiaInduction of anesthesia will be by IV propofol (2-2.5 mg/kg) | Drug | Erector spinae plane block, Thoracolumbar interfascial plane block, control group |
| FentanylAlso: Intravenous narcoticFentanyl will be injected during the induction of anesthesia (1-1.5 mg/kg) | Drug | Erector spinae plane block, Thoracolumbar interfascial plane block, control group |
| RocuroniumAlso: Muscle relaxantRocuronium will be injected during induction of anesthesia (0.6 mg/ kg) | Drug | Erector spinae plane block, Thoracolumbar interfascial plane block, control group |
| SevofluraneAlso: Inhalational anestheticSevoflurane inhalationa anesthesia will be used for maintainance of anesthesia | Drug | Erector spinae plane block, Thoracolumbar interfascial plane block, control group |
| Erector spinae plane blockIn 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. | Other | Erector spinae plane block |
| Thoracolumbar interfascial plane blockIn 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. | Other | Thoracolumbar interfascial plane block |
Primary outcome
Total postoperative fentanyl requirements
Time frame: 24 hours
Total postoperative fentanyl requirements
3 secondary outcomes
pain score at rest and during movement
Time frame: 24 hours
time of first postoperative analgesic request
Time frame: 24 hours
opioids side effects
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.