Post Operative Pain ManagementNCT05880017
Thoracolumbar Interfascial Plane Block in Lumber Spine Surgery
A study testing Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block., Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block. and Bupivacain in people with Post Operative Pain Management, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare modified versus conventional thoracolumbar interfascial plane block for perioperative analgesia in lumber spine surgery. The main question it aims to answer is: Whether modified thoracolumbar interfascial plane block is as effective as the conventional block for… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Operative Pain Management
- What is being tested?
- Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block., Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block. and Bupivacain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 Jun 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes admitted to the OR of Ain Shams University Hospitals for lumber disc surgery.
- Age 18 to 70 year old.
- ASA classification I and II.
Who cannot join
- Age <18 or >70 years.
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- Psychiatric disorder.
- ASA classification III-V.
- Patients with cerebrovascular accidents.
Show all 9Show fewer
- Neuromuscular disorders, spine abnormalities.
- Spinal cord or head injuries.
- CNS tumours.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams university hospitals
Cairo, Al Abbassia, 11591
Diaaeldein M Haiba Ali Ibrahim, MD, +201006516286, diaaeldein@med.asu.edu.eg
About this study
Official title: Modified Versus Conventional Thoracolumbar Interfascial Plane Block for Perioperative Analgesia in Lumber Spine Surgery. A Randomized Controlled Study.
The goal of this clinical trial is to compare modified versus conventional thoracolumbar interfascial plane block for perioperative analgesia in lumber spine surgery.
The main question it aims to answer is:
- Whether modified thoracolumbar interfascial plane block is as effective as the conventional block for perioperative analgesia in lumber spine surgery.
60 patients were enrolled in the study, divided by simple random sampling into 3 groups.
Read the detailed description
Spinal surgeries are usually associated with marked postoperative pain that classically takes 3 days to recede.
Adequate perioperative pain control is significant for patients to encourage early mobilization and reduce postoperative adverse events. Discectomy, laminectomy, and spinal fixation are the most frequently performed spinal surgical procedures. Extensive dissection of tissues, ligaments, and bones is often performed during spinal surgeries, resulting in a significant degree of postoperative severe pain. Adequate pain management in these patients is challenging because most of them have already received ordinary analgesics and/or opioids to ameliorate preexistent chronic back pain. Pain following spine surgery can result from mechanical irritation, nerve compression, or postoperative inflammatory processes. It can be generated from different structures such as vertebrae, discs, ligaments, muscles, dural sleeves, and capsules of the facet joint. Innervation of these pain generators is from the dorsal rami of spinal nerves. Opioids are considered the standard method of analgesia and are commonly used as effective analgesics for the management of severe pain disorders. However, their widespread use is restricted because of their side effects such as nausea, vomiting, and respiratory distress, and acquired tolerance. Preemptive multimodal analgesic regimens that rely on the synergistic action of nonopioid agents given in lower doses have been used to improve postoperative pain management and reduce opioid consumption. Protocols for reducing pain after lumbar surgery recommend the use of regional anesthesia techniques to reduce opioid analgesic use to the minimum. Interfascial plane blocks have the potential to provide extended postoperative analgesia and to reduce opioid consumption and neuraxial-related motor block to a minimum. The use of thoracolumbar interfascial plane block TLIP block was first reported in 2015 by Hand et al. wherein they did a volunteer-based study and demarcated the area of sensory analgesia. Thereafter, Ueshima et al. reported two cases of spinal surgeries where TLIP block was administered. TLIP blocks the sensory component of the dorsal rami of the thoracolumbar nerves. These nerves emerge mainly through the interface between the multifidus (MF) and longissimus (LG) muscles. Blocking these nerves provides good analgesia after spine surgeries. TLIP modification where we inject the anaesthetics between the longissimus and iliocostalis muscles after having advanced the needles at a 15 angle in a medial to lateral direction. This modified method has several advantages. 1.Advancing the needle from a medial to lateral direction eliminates the risk of possible inadvertent neuraxial injection. 2.Injecting between the iliocostalis and longissimus muscles results in a dermatomal area of analgesia similar to that obtained with an injection made between the multifidus and longissimus muscles. Both conventional and modified techniques are assumed to be effective and safe.
The primary outcome measure is postoperative pain intensity expressed as A numerical rating scale (NRS) score at time zero (time of extubation), time 1 ( time of delivery to PACU), every 2 hours during the first 6 hours then every 6 hours during the first 24 hours.
- Conditions
- Post Operative Pain Management
- Being tested
- Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block., Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block., Morphine for peritoperative analgesia (control group)., Bupivacain
- Keywords
- Thoracolumber, Interfascial plane, Lumber discectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block.Procedure or surgery
Patients will be placed in a prone position; modified ultrasound guided TLIP block will be performed using a SonoSite 2-5 MHZ Curved array (C60X) transducer. The transducer will be positioned in a transverse midline position at the level of the L3 vertebra. After the identification of the spinous process and interspinous muscles, the probe will be moved laterally to identify longissimus (LG) and intercostalis muscles. After identifying the muscles and decontamination of the skin, the modified TLIP block will be performed under real-time ultrasound guidance using an insulated 90-mm 22G echogenic needle which will be inserted at a 15ºangle from the skin in-plane in a medial to lateral direction injecting the anesthetic locally between the longissimus and intercostalis muscles, which are easy to define using ultrasonography. After negative aspiration, injection will be in each side bilaterally in the interface between the LG and intercostalis muscles.
Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block.Procedure or surgery
Patients will be placed in a prone position; conventional ultrasound guided TLIP block will be performed using a SonoSite 2-5 MHZ Curved array (C60X) transducer. The transducer will be positioned in a transverse midline position at the level of the L3 vertebra. After the identification of the spinous process and interspinous muscles, the probe will be moved laterally to identify the multifidus (MF) and longissimus (LG) muscles. After identifying the muscles and decontamination of the skin, the TLIP block will be performed under real-time ultrasound guidance using an insulated 90-mm 22G echogenic needle which will be inserted at a 30ºangle from the skin in-plane lateral to the medial direction through the belly of the LG toward the MF muscle. After negative aspiration, injection will be done in each side bilaterally in the interface between the MF and LG muscles.
Morphine for peritoperative analgesia (control group).Drug
Morphine based analgesia, after emergence they will receive 5mg morphine IV as a start and the rest of the first 24 hours they will receive incremental dose of intravenous morphine according to pain score.
BupivacainDrug
As a local anesthetic will be injected in modified and conventional groups 20ml in each side.
| Study group | Role | What they receive |
|---|---|---|
| Modified Group | Active comparator | A total of 20 patients undergoing lumber spine surgery receiving modified ultrasound guided thoracolumbar interfascial plane (TLIP) block. Receives: Procedure: Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block.; Drug: Bupivacain |
| Conventional Group | Active comparator | A total of 20 patients undergoing lumber spine surgery receiving conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block. Receives: Procedure: Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block.; Drug: Bupivacain |
| Morphine Group | Active comparator | A total of 20 patients undergoing lumber spine surgery receiving morphine for peritoperative analgesia (control group). Receives: Drug: Morphine for peritoperative analgesia (control group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain intensity expressed as A numerical rating scale (NRS) score at time zero (time of extubation).
The numerical rating scale consists of a numeric version of the visual analogue scale. The most common form of the NRS is a horizontal line with an eleven point numeric range.
The numerical rating scale requires the patient to rate their pain on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Measured: Time 0 (Time of Extubation)
Secondary outcomes (6)
Pain intensity expressed as A numerical rating scale (NRS) score at time 1 (time of delivery to Post Anesthesia Care Unit PACU).
The numerical rating scale consists of a numeric version of the visual analogue scale. The most common form of the NRS is a horizontal line with an eleven point numeric range.
The numerical rating scale requires the patient to rate their pain on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Measured: Time 1 (30 minutes after extubation in the Post Anesthesia Care Unit (PACU).
Pain intensity expressed as A numerical rating scale (NRS) score at time 6 (6 hours postoperative).
The numerical rating scale consists of a numeric version of the visual analogue scale. The most common form of the NRS is a horizontal line with an eleven point numeric range.
The numerical rating scale requires the patient to rate their pain on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Measured: Time 6 (6 hours postoperative)
Pain intensity expressed as A numerical rating scale (NRS) score at time 24 (24 hours postoperative).
The numerical rating scale consists of a numeric version of the visual analogue scale. The most common form of the NRS is a horizontal line with an eleven point numeric range.
The numerical rating scale requires the patient to rate their pain on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Measured: Time 24 (24 hours postoperative)
Early ambulation.
Time of starting ambulation postoperative
Measured: Time of ambulation during first 24 hours postoperative
Time of first rescue analgesic.
As-needed dose of opioid (morphine) to provide relief of first breakthrough pain.
Measured: During First 24 hours postoperative.
Total dose of Postoperative morphine consumption during first 24 hours.
Dose of morphine in milligram
Measured: During first 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Dec 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain ManagementStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective , randomized controlled, comparative study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaaeldein Mahmoud Haiba, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880017
- Sponsor's protocol ID
- FMASU R 167/2022
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Versus Conventional Thoracolumbar Interfascial Plane Block for Perioperative Analgesia in Lumber Spine Surgery. A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05880017
- Acronym / sponsor ID
- FMASU R 167/2022
- Conditions
- Post Operative Pain Management
- Keywords
- Thoracolumber, Interfascial plane, Lumber discectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 30 May 2023 (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.
The goal of this clinical trial is to compare modified versus conventional thoracolumbar interfascial plane block for perioperative analgesia in lumber spine surgery.
The main question it aims to answer is:
- Whether modified thoracolumbar interfascial plane block is as effective as the conventional block for perioperative analgesia in lumber spine surgery.
60 patients were enrolled in the study, divided by simple random sampling into 3 groups.
Detailed description
Spinal surgeries are usually associated with marked postoperative pain that classically takes 3 days to recede.
Adequate perioperative pain control is significant for patients to encourage early mobilization and reduce postoperative adverse events. Discectomy, laminectomy, and spinal fixation are the most frequently performed spinal surgical procedures. Extensive dissection of tissues, ligaments, and bones is often performed during spinal surgeries, resulting in a significant degree of postoperative severe pain. Adequate pain management in these patients is challenging because most of them have already received ordinary analgesics and/or opioids to ameliorate preexistent chronic back pain. Pain following spine surgery can result from mechanical irritation, nerve compression, or postoperative inflammatory processes. It can be generated from different structures such as vertebrae, discs, ligaments, muscles, dural sleeves, and capsules of the facet joint. Innervation of these pain generators is from the dorsal rami of spinal nerves. Opioids are considered the standard method of analgesia and are commonly used as effective analgesics for the management of severe pain disorders. However, their widespread use is restricted because of their side effects such as nausea, vomiting, and respiratory distress, and acquired tolerance. Preemptive multimodal analgesic regimens that rely on the synergistic action of nonopioid agents given in lower doses have been used to improve postoperative pain management and reduce opioid consumption. Protocols for reducing pain after lumbar surgery recommend the use of regional anesthesia techniques to reduce opioid analgesic use to the minimum. Interfascial plane blocks have the potential to provide extended postoperative analgesia and to reduce opioid consumption and neuraxial-related motor block to a minimum. The use of thoracolumbar interfascial plane block TLIP block was first reported in 2015 by Hand et al. wherein they did a volunteer-based study and demarcated the area of sensory analgesia. Thereafter, Ueshima et al. reported two cases of spinal surgeries where TLIP block was administered. TLIP blocks the sensory component of the dorsal rami of the thoracolumbar nerves. These nerves emerge mainly through the interface between the multifidus (MF) and longissimus (LG) muscles. Blocking these nerves provides good analgesia after spine surgeries. TLIP modification where we inject the anaesthetics between the longissimus and iliocostalis muscles after having advanced the needles at a 15 angle in a medial to lateral direction. This modified method has several advantages. 1.Advancing the needle from a medial to lateral direction eliminates the risk of possible inadvertent neuraxial injection. 2.Injecting between the iliocostalis and longissimus muscles results in a dermatomal area of analgesia similar to that obtained with an injection made between the multifidus and longissimus muscles. Both conventional and modified techniques are assumed to be effective and safe.
The primary outcome measure is postoperative pain intensity expressed as A numerical rating scale (NRS) score at time zero (time of extubation), time 1 ( time of delivery to PACU), every 2 hours during the first 6 hours then every 6 hours during the first 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective , randomized controlled, comparative study.
| Arm | Type | Receives |
|---|---|---|
| Modified Group | Active comparator | Procedure: Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block., Drug: BupivacainA total of 20 patients undergoing lumber spine surgery receiving modified ultrasound guided thoracolumbar interfascial plane (TLIP) block. |
| Conventional Group | Active comparator | Procedure: Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block., Drug: BupivacainA total of 20 patients undergoing lumber spine surgery receiving conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block. |
| Morphine Group | Active comparator | Drug: Morphine for peritoperative analgesia (control group).A total of 20 patients undergoing lumber spine surgery receiving morphine for peritoperative analgesia (control group). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both sexes admitted to the OR of Ain Shams University Hospitals for lumber disc surgery.
- Age 18 to 70 year old.
- ASA classification I and II.
Key exclusion criteria (9 listed)
- Age <18 or >70 years.
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- Psychiatric disorder.
- ASA classification III-V.
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 |
|---|---|---|
| Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block.Patients will be placed in a prone position; modified ultrasound guided TLIP block will be performed using a SonoSite 2-5 MHZ Curved array (C60X) transducer. The transducer will be positioned in a transverse midline position at the level of the L3 vertebra. After the identification of the spinous process and interspinous muscles, the probe will be moved laterally to identify longissimus (LG) and intercostalis muscles. After identifying the muscles and decontamination of the skin, the modified TLIP block will be performed under real-time ultrasound guidance using an insulated 90-mm 22G echogenic needle which will be inserted at a 15ºangle from the skin in-plane in a medial to lateral direction injecting the anesthetic locally between the longissimus and intercostalis muscles, which are easy to define using ultrasonography. After negative aspiration, injection will be in each side bilaterally in the interface between the LG and intercostalis muscles. | Procedure or surgery | Modified Group |
| Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block.Patients will be placed in a prone position; conventional ultrasound guided TLIP block will be performed using a SonoSite 2-5 MHZ Curved array (C60X) transducer. The transducer will be positioned in a transverse midline position at the level of the L3 vertebra. After the identification of the spinous process and interspinous muscles, the probe will be moved laterally to identify the multifidus (MF) and longissimus (LG) muscles. After identifying the muscles and decontamination of the skin, the TLIP block will be performed under real-time ultrasound guidance using an insulated 90-mm 22G echogenic needle which will be inserted at a 30ºangle from the skin in-plane lateral to the medial direction through the belly of the LG toward the MF muscle. After negative aspiration, injection will be done in each side bilaterally in the interface between the MF and LG muscles. | Procedure or surgery | Conventional Group |
| Morphine for peritoperative analgesia (control group).Morphine based analgesia, after emergence they will receive 5mg morphine IV as a start and the rest of the first 24 hours they will receive incremental dose of intravenous morphine according to pain score. | Drug | Morphine Group |
| BupivacainAs a local anesthetic will be injected in modified and conventional groups 20ml in each side. | Drug | Conventional Group, Modified Group |
Primary outcome
postoperative pain intensity expressed as A numerical rating scale (NRS) score at time zero (time of extubation).
Time frame: Time 0 (Time of Extubation)
The numerical rating scale consists of a numeric version of the visual analogue scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. The numerical rating scale requires the patient to rate their pain on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
6 secondary outcomes
Pain intensity expressed as A numerical rating scale (NRS) score at time 1 (time of delivery to Post Anesthesia Care Unit PACU).
Time frame: Time 1 (30 minutes after extubation in the Post Anesthesia Care Unit (PACU).
Pain intensity expressed as A numerical rating scale (NRS) score at time 6 (6 hours postoperative).
Time frame: Time 6 (6 hours postoperative)
Pain intensity expressed as A numerical rating scale (NRS) score at time 24 (24 hours postoperative).
Time frame: Time 24 (24 hours postoperative)
Early ambulation.
Time frame: Time of ambulation during first 24 hours postoperative
Time of first rescue analgesic.
Time frame: During First 24 hours postoperative.
Total dose of Postoperative morphine consumption during first 24 hours.
Time frame: During first 24 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block., Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block. and Bupivacain in people with Post Operative Pain Management, run by Ain Shams 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 3 inclusion and 9 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 30 May 2023. 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?
Contact Diaaeldein Ibrahim, Lecturer (+201006516286, diaaeldein@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain intensity expressed as A numerical rating scale (NRS) score at time zero (time of extubation). (time frame: Time 0 (Time of Extubation)). 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 30 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.