Postoperative PainNCT05276908
Different Volumes of Local Anesthetics in Thoracolumbar Interfascial Plane Block
A study testing Thoracolumbar interfascial plane block (TLIP)Technique, Anesthetic Management and Bupivacaine Injection 10ml in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Ultrasound-guided thoracolumbar interfascial plane block (TLIP)was first described in 2015 by Hand et al which also target the dorsal rami of the thoracolumbar nerves as they pass through the paraspinal musculature(between the multifidus muscle (MF) and the longissimus muscle (LG)). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Thoracolumbar interfascial plane block (TLIP)Technique, Anesthetic Management and Bupivacaine Injection 10ml
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2022to 3 Dec 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ● Both gender
- Type of surgery: lumbar spine surgeries involving 1 up to 3 adjacent lumbar vertebrae
- Physical status ASA I, II.
- Age 18 to 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
Who cannot join
- ● Patients on preoperative opioid regimen for more than 1 month.
- Patients with history of previous surgical operations in the lumbar region.
- Patients with spinal deformities (eg. Scoliosis…..).
- Hypersensitivity to Bupivacaine.
- Extensive Lumbar spine surgeries like large tumor excisions, scoliosis correction or more than 2 level spine fixations.
- Patients with communication difficulties.
- Lumbar spine operations that will be performed with the patient in any position other than the prone position.
- Severe neurological compromise (severe muscle weakness such as foot drop or sphincter disorders such as urinary incontinence).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Two Different Volumes of Local Anesthetics in Ultrasound-guided Modified Approach of Thoracolumbar Block in Patients Undergoing Lumbar Spine Surgeries; a Randomized Controlled Trial.
Ultrasound-guided thoracolumbar interfascial plane block (TLIP)was first described in 2015 by Hand et al which also target the dorsal rami of the thoracolumbar nerves as they pass through the paraspinal musculature(between the multifidus muscle (MF) and the longissimus muscle (LG)). The block was performed bilaterally at the level of L3 and they reported a reproducible area of anesthesia to pinprick in a mean (SD) area covering 137.4 (71.0) cm2 of the lower back (including the midline) after 20 minutes of the block. This procedure has subsequently been modified by Ueshima H et al in 2016 by targeting the injection in the plane between the longissimus and iliocostalis muscles (mTLIP) which helps avoiding the spread of local anesthetics to the ventral ramus and neuraxial space, thus, the modified TLIP block is considered to be a more refined version of the original TLIP block and safer and easier to perform.
There are limited number of studies investigating the analgesic efficacy of mTLIP block however, no previous study has demonstrated the ideal local anesthetic volume for this block in lumber spine surgery. Moreover, this technique is considered new regional anesthetic techniques and so both of them should be involved in further studies, on the other hand the comparison between both of them at the same study wasn't discussed before, and so we will proceed at this study.
Read the detailed description
The aim of this study is to compare the post-operative analgesic efficacy of two different volumes of local anesthetics in bilateral modified thoracolumbar interfascial plane block in lumbar spine surgeries.
Prospective randomized double blinded study The study will be conducted in Kasr Alainy hospital orthopedic surgical theater. Adult patients undergoing lumbar spine surgeries involving 1 up to 3 adjacent lumbar vertebrae (eg. laminectomy, discectomy …). at Kasr Alainy hospital.
- Conditions
- Postoperative Pain
- Being tested
- Thoracolumbar interfascial plane block (TLIP)Technique, Anesthetic Management, Bupivacaine Injection 10ml, Bupivacaine Injection 20ml
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracolumbar interfascial plane block (TLIP)TechniqueProcedure or surgery
A curvilinear array ultrasound probe (Siemens ACUSON X300 Ultrasound System) will be placed at the targeted lumbar level.The corresponding spinous process and interspinal muscles will be identified, and the probe will be slided laterally to identify the longissimus muscle and iliocostalis muscle. Under ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a medial to lateral orientation through the belly of longissimus muscle toward the iliocostalis muscle. Hydro-dissection with 2-3 ml of isotonic saline solution will confirm the correct needle tip position and, after negative aspiration, 0.25 % bupivacaine will be injected slowly whilst carefully monitoring the spread of local anesthetic into the fascial plane between the longissimus and iliocostalis muscles. The same procedure will be repeated on the contralateral side.
Anesthetic ManagementProcedure or surgery
Induction:
Induction of general anesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of atracurium.
Maintenance:
Anesthesia will be maintained with inhaled isoflurane 0.8% in oxygen enriched air (FiO2=0.5). Maintenance doses of 0.1 m\kg atracurium will be provided every 30 minutes. Then the patient will be placed in prone position.
Bupivacaine Injection 10mlDrug
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side).
Bupivacaine Injection 20mlDrug
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side).
| Study group | Role | What they receive |
|---|---|---|
| mTLIP10 | Experimental | patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side). Receives: Procedure: Thoracolumbar interfascial plane block (TLIP)Technique; Procedure: Anesthetic Management; Drug: Bupivacaine Injection 10ml |
| mTLIP20 | Experimental | patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side). Receives: Procedure: Thoracolumbar interfascial plane block (TLIP)Technique; Procedure: Anesthetic Management; Drug: Bupivacaine Injection 20ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption in the first 24 hours postoperative
Measured: 24 hours
Secondary outcomes (2)
Time to first rescue analgesia
measured from time of block administration to time of rescue analgesia administration
Measured: 24 hours
Numeric Pain Rating Scale
Pain scale of managmet when zero indicates no pain and ten indicates maximum pain both at rest and during movement: 30 minutes,2, 4,6, 8, 12, 16, 20 and 24postoperatively.
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 posted14 Mar 2022
- Study start3 Mar 2022
- Primary completion3 Nov 2022
- Study completion3 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant M. Abdelhamid, Cairo University
- Investigators
- Bassant Abdelhamid, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276908
- Sponsor's protocol ID
- MD-307-2020
- Status last verified
- Dec 2022
- First submitted
- 28 Feb 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ammar MA, Taeimah M. Evaluation of thoracolumbar interfascial plane block for postoperative analgesia after herniated lumbar disc surgery: A randomized clinical trial. Saudi J Anaesth. 2018 Oct-Dec;12(4):559-564. doi: 10.4103/sja.SJA_177_18.
PubMed 30429737Li C, Jia J, Qin Z, Tang Z. The use of ultrasound-guided modified thoracolumbar interfascial plane (TLIP) block for multi-level lumbar spinal surgery. J Clin Anesth. 2018 May;46:49-51. doi: 10.1016/j.jclinane.2018.01.018. Epub 2018 Mar 26. No abstract available.
PubMed 29414616Abdelhamid B, Ayman E, Nabil T, Hamimy WI, El-Monem Morsy MA. Analgesic efficacy of two different volumes of local anaesthetics in ultrasound-guided modified approach to the thoracolumbar interfascial plane block in patients undergoing lumbar spine surgeries: a randomized controlled trial. Anaesthesiol Intensive Ther. 2023;55(5):358-365. doi: 10.5114/ait.2023.134196.
PubMed 38282503
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Two Different Volumes of Local Anesthetics in Ultrasound-guided Modified Approach of Thoracolumbar Block in Patients Undergoing Lumbar Spine Surgeries; a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05276908
- Acronym / sponsor ID
- MD-307-2020
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Dec 2022 (actual)
- First posted
- 14 Mar 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.
Ultrasound-guided thoracolumbar interfascial plane block (TLIP)was first described in 2015 by Hand et al which also target the dorsal rami of the thoracolumbar nerves as they pass through the paraspinal musculature(between the multifidus muscle (MF) and the longissimus muscle (LG)). The block was performed bilaterally at the level of L3 and they reported a reproducible area of anesthesia to pinprick in a mean (SD) area covering 137.4 (71.0) cm2 of the lower back (including the midline) after 20 minutes of the block. This procedure has subsequently been modified by Ueshima H et al in 2016 by targeting the injection in the plane between the longissimus and iliocostalis muscles (mTLIP) which helps avoiding the spread of local anesthetics to the ventral ramus and neuraxial space, thus, the modified TLIP block is considered to be a more refined version of the original TLIP block and safer and easier to perform.
There are limited number of studies investigating the analgesic efficacy of mTLIP block however, no previous study has demonstrated the ideal local anesthetic volume for this block in lumber spine surgery. Moreover, this technique is considered new regional anesthetic techniques and so both of them should be involved in further studies, on the other hand the comparison between both of them at the same study wasn't discussed before, and so we will proceed at this study.
Detailed description
The aim of this study is to compare the post-operative analgesic efficacy of two different volumes of local anesthetics in bilateral modified thoracolumbar interfascial plane block in lumbar spine surgeries.
Prospective randomized double blinded study The study will be conducted in Kasr Alainy hospital orthopedic surgical theater. Adult patients undergoing lumbar spine surgeries involving 1 up to 3 adjacent lumbar vertebrae (eg. laminectomy, discectomy …). at Kasr Alainy hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mTLIP10 | Experimental | Procedure: Thoracolumbar interfascial plane block (TLIP)Technique, Procedure: Anesthetic Management, Drug: Bupivacaine Injection 10mlpatients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side). |
| mTLIP20 | Experimental | Procedure: Thoracolumbar interfascial plane block (TLIP)Technique, Procedure: Anesthetic Management, Drug: Bupivacaine Injection 20mlpatients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ● Both gender
Key exclusion criteria (8 listed)
- ● Patients on preoperative opioid regimen for more than 1 month.
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 |
|---|---|---|
| Thoracolumbar interfascial plane block (TLIP)TechniqueA curvilinear array ultrasound probe (Siemens ACUSON X300 Ultrasound System) will be placed at the targeted lumbar level.The corresponding spinous process and interspinal muscles will be identified, and the probe will be slided laterally to identify the longissimus muscle and iliocostalis muscle. Under ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a medial to lateral orientation through the belly of longissimus muscle toward the iliocostalis muscle. Hydro-dissection with 2-3 ml of isotonic saline solution will confirm the correct needle tip position and, after negative aspiration, 0.25 % bupivacaine will be injected slowly whilst carefully monitoring the spread of local anesthetic into the fascial plane between the longissimus and iliocostalis muscles. The same procedure will be repeated on the contralateral side. | Procedure or surgery | mTLIP10, mTLIP20 |
| Anesthetic ManagementInduction: Induction of general anesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of atracurium. Maintenance: Anesthesia will be maintained with inhaled isoflurane 0.8% in oxygen enriched air (FiO2=0.5). Maintenance doses of 0.1 m\kg atracurium will be provided every 30 minutes. Then the patient will be placed in prone position. | Procedure or surgery | mTLIP10, mTLIP20 |
| Bupivacaine Injection 10mlpatients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side). | Drug | mTLIP10 |
| Bupivacaine Injection 20mlpatients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side). | Drug | mTLIP20 |
Primary outcome
Total morphine consumption in the first 24 hours postoperative
Time frame: 24 hours
2 secondary outcomes
Time to first rescue analgesia
Time frame: 24 hours
Numeric Pain Rating Scale
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 19 Dec 2022.
- Background: PubMed 30429737Ammar MA, Taeimah M. Evaluation of thoracolumbar interfascial plane block for postoperative analgesia after herniated lumbar disc surgery: A randomized clinical trial. Saudi J Anaesth. 2018 Oct-Dec;12(4):559-564. doi: 10.4103/sja.SJA_177_18.
- Background: PubMed 29414616Li C, Jia J, Qin Z, Tang Z. The use of ultrasound-guided modified thoracolumbar interfascial plane (TLIP) block for multi-level lumbar spinal surgery. J Clin Anesth. 2018 May;46:49-51. doi: 10.1016/j.jclinane.2018.01.018. Epub 2018 Mar 26. No abstract available.
- Derived from this study: PubMed 38282503Abdelhamid B, Ayman E, Nabil T, Hamimy WI, El-Monem Morsy MA. Analgesic efficacy of two different volumes of local anaesthetics in ultrasound-guided modified approach to the thoracolumbar interfascial plane block in patients undergoing lumbar spine surgeries: a randomized controlled trial. Anaesthesiol Intensive Ther. 2023;55(5):358-365. doi: 10.5114/ait.2023.134196.
- 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.
Bassant Abdelhamid principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracolumbar interfascial plane block (TLIP)Technique, Anesthetic Management and Bupivacaine Injection 10ml in people with Postoperative Pain, run by Cairo 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 5 inclusion and 8 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 19 Dec 2022. 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?
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 morphine consumption in the first 24 hours postoperative (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05276908, which also lists 3 linked publications.
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 19 Dec 2022.