Lumbar Disc SurgeryPhase 4NCT06690021
Comparing The Effect of Adding Dexmedetomidine to Bupivacaine in Classical and Modified Thoracolumbar Interfascial Plane Block on Postoperative Pain in Patients Undergoing Lumbar Disc Surgeries
A Phase 4 study testing Dexmedetomidine in people with Lumbar Disc Surgery, run by Assiut University.
Trial summary
Spinal surgeries are frequently conducted to stabilize the vertebrae and discs of the spine. These surgeries typically require substantial manipulation of subcutaneous tissues, bones, and ligaments . Postoperative pain relates to mechanical irritation, compression, and postoperative inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Surgery
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age >18 years old
- Both sex
- Patients who were in risk-scoring groups I-II of the American Society of Anesthesiologists (ASA)
Who cannot join
- • Patient refusal.
- coagulation disorders that affect the blood's clotting activities e.g.: Hemophilia.
- skin lesions or infection at site of proposed needle.
- known allergy to local anesthetics or dexmedetomidine.
- patients suffering from mental disease as cannot Assess the Visual Analogue Scale (VAS) that measures pain intensity as, mental retardation \& psychosis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Spinal surgeries are frequently conducted to stabilize the vertebrae and discs of the spine. These surgeries typically require substantial manipulation of subcutaneous tissues, bones, and ligaments . Postoperative pain relates to mechanical irritation, compression, and postoperative inflammation. The uncontrolled pain could promote the development of chronic persistent pain and worsen independence, mood, and quality of life. Effective pain management facilitates early mobilisation and accelerates hospital discharge. this study aim to investigate the effectiveness of a mixture of dexmedetomidine and bupivacaine in classical thoracolumbar interfascial plane block compare to modified thoracolumbar interfascial plane block on postoperative pain in patients undergoing lumbar disc surgeries.
Read the detailed description
Postoperative pain control after spinal surgeries has been a topic of interest for researchers in the past decade. Indeed, poor pain control can not only impact patient satisfaction but also delay rehabilitation and increase healthcare costs.
The thoracolumbar interfascial plane (TLIP) block was defined by Hand et al. for reducing pain following spinal surgery. In this block, the anesthetic drug is administered between the multifidus and longissimus muscles to target the dorsal ramus of the thoracolumbar nerves. The TLIP block was later modified by Ahiskalioglu et al., with the involvement of the administration of a local anesthetic between the longissimus and iliocostalis, which was observed to demonstrate a dermatomal dispersion similar to that by the TLIP block.
Dexmedetomidine is highly specific and highly selective a2-adrenoceptive agonist and it's action is selective to the CNS without the unwanted effect on the CVS that would result from a activation . It has been found that, in many experimental and clinical regional block practices, the addition of dexmedetomidine to the local anesthetic reduces tissue and nerve damage, increases duration of sensory and motor block, and reduces postoperative pain.
- Conditions
- Lumbar Disc Surgery
- Being tested
- Dexmedetomidine
- Keywords
- Dexmedetomidine, Classical and Modified Thoracolumbar Interfascial Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Thoracolumbar Interfascial Plane Block using Bupivacaine and dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Classical Thoracolumbar Interfascial Plane Block Receives: Drug: Dexmedetomidine |
| group 2 | Experimental | Modified Thoracolumbar Interfascial Plane Block Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
total opioid consumption
To assess the total perioperative (intraoperative and 24 h postoperative) opioid consumption in the first 24 h.
Measured: 24 hours
Secondary outcomes (1)
post operative VAS score
Postoperative pain will be assessed using an 11-point (0=no pain and 10=worst pain) VAS scale. VAS for pain at rest and when coughing will be assessed serially at 1, 2, 4, 8, 16 and 24 h after surgery
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 posted15 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohand Mohamed Fathy Salem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690021
- Sponsor's protocol ID
- Dexmedetomidine TLIP lumbar
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 30429737Sarvesh B, Shivaramu BT, Sharma K, Agarwal A. Addition of Dexmedetomidine to Ropivacaine in Subcostal Transversus Abdominis Plane Block Potentiates Postoperative Analgesia among Laparoscopic Cholecystectomy Patients: A Prospective Randomized Controlled Trial. Anesth Essays Res. 2018 Oct-Dec;12(4):809-813. doi: 10.4103/aer.AER_141_18.
PubMed 30662112Nasr DA, Abdelhamid HM. The efficacy of caudal dexmedetomidine on stress response and postoperative pain in pediatric cardiac surgery. Ann Card Anaesth. 2013 Apr-Jun;16(2):109-14. doi: 10.4103/0971-9784.109744.
PubMed 23545865Tantri AR, Sukmono RB, Lumban Tobing SDA, Natali C. Comparing the Effect of Classical and Modified Thoracolumbar Interfascial Plane Block on Postoperative Pain and IL-6 Level in Posterior Lumbar Decompression and Stabilization Surgery. Anesth Pain Med. 2022 Apr 12;12(2):e122174. doi: 10.5812/aapm-122174. eCollection 2022 Apr.
PubMed 36061531Mondal S, Pandey RK, Kumar M, Sharma A, Darlong V, Punj J. Analgesic efficacy of classical thoracolumbar interfascial plane block versus modified thoracolumbar interfascial plane block in patients undergoing lumbar disc surgeries: A comparative, randomised controlled trial. Indian J Anaesth. 2024 Apr;68(4):366-373. doi: 10.4103/ija.ija_1153_23. Epub 2024 Mar 13.
PubMed 38586260Khan MA, Gupta M, Sharma S, Kasaudhan S. A comparative study of ultrasound assisted versus landmark technique for combined spinal-epidural anaesthesia in patients undergoing lower limb orthopaedic surgery. Indian J Anaesth. 2022 Apr;66(4):272-277. doi: 10.4103/ija.ija_775_21. Epub 2022 Apr 20.
PubMed 35663223
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing The Effect of Adding Dexmedetomidine to Bupivacaine in Classical and Modified Thoracolumbar Interfascial Plane Block on Postoperative Pain in Patients Undergoing Lumbar Disc Surgeries
- ClinicalTrials.gov ID
- NCT06690021
- Acronym / sponsor ID
- Dexmedetomidine TLIP lumbar
- Conditions
- Lumbar Disc Surgery
- Keywords
- Dexmedetomidine, Classical and Modified Thoracolumbar Interfascial Plane Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 15 Nov 2024 (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.
Spinal surgeries are frequently conducted to stabilize the vertebrae and discs of the spine. These surgeries typically require substantial manipulation of subcutaneous tissues, bones, and ligaments . Postoperative pain relates to mechanical irritation, compression, and postoperative inflammation. The uncontrolled pain could promote the development of chronic persistent pain and worsen independence, mood, and quality of life. Effective pain management facilitates early mobilisation and accelerates hospital discharge. this study aim to investigate the effectiveness of a mixture of dexmedetomidine and bupivacaine in classical thoracolumbar interfascial plane block compare to modified thoracolumbar interfascial plane block on postoperative pain in patients undergoing lumbar disc surgeries.
Detailed description
Postoperative pain control after spinal surgeries has been a topic of interest for researchers in the past decade. Indeed, poor pain control can not only impact patient satisfaction but also delay rehabilitation and increase healthcare costs.
The thoracolumbar interfascial plane (TLIP) block was defined by Hand et al. for reducing pain following spinal surgery. In this block, the anesthetic drug is administered between the multifidus and longissimus muscles to target the dorsal ramus of the thoracolumbar nerves. The TLIP block was later modified by Ahiskalioglu et al., with the involvement of the administration of a local anesthetic between the longissimus and iliocostalis, which was observed to demonstrate a dermatomal dispersion similar to that by the TLIP block.
Dexmedetomidine is highly specific and highly selective a2-adrenoceptive agonist and it's action is selective to the CNS without the unwanted effect on the CVS that would result from a activation . It has been found that, in many experimental and clinical regional block practices, the addition of dexmedetomidine to the local anesthetic reduces tissue and nerve damage, increases duration of sensory and motor block, and reduces postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: DexmedetomidineClassical Thoracolumbar Interfascial Plane Block |
| group 2 | Experimental | Drug: DexmedetomidineModified Thoracolumbar Interfascial Plane Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Age >18 years old
Key exclusion criteria (5 listed)
- • Patient refusal.
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 |
|---|---|---|
| DexmedetomidineThoracolumbar Interfascial Plane Block using Bupivacaine and dexmedetomidine | Drug | group 1, group 2 |
Primary outcome
total opioid consumption
Time frame: 24 hours
To assess the total perioperative (intraoperative and 24 h postoperative) opioid consumption in the first 24 h.
1 secondary outcome
post operative VAS score
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Results publication: 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.
- Results publication: PubMed 30662112Sarvesh B, Shivaramu BT, Sharma K, Agarwal A. Addition of Dexmedetomidine to Ropivacaine in Subcostal Transversus Abdominis Plane Block Potentiates Postoperative Analgesia among Laparoscopic Cholecystectomy Patients: A Prospective Randomized Controlled Trial. Anesth Essays Res. 2018 Oct-Dec;12(4):809-813. doi: 10.4103/aer.AER_141_18.
- Results publication: PubMed 23545865Nasr DA, Abdelhamid HM. The efficacy of caudal dexmedetomidine on stress response and postoperative pain in pediatric cardiac surgery. Ann Card Anaesth. 2013 Apr-Jun;16(2):109-14. doi: 10.4103/0971-9784.109744.
- Results publication: PubMed 36061531Tantri AR, Sukmono RB, Lumban Tobing SDA, Natali C. Comparing the Effect of Classical and Modified Thoracolumbar Interfascial Plane Block on Postoperative Pain and IL-6 Level in Posterior Lumbar Decompression and Stabilization Surgery. Anesth Pain Med. 2022 Apr 12;12(2):e122174. doi: 10.5812/aapm-122174. eCollection 2022 Apr.
- Results publication: PubMed 38586260Mondal S, Pandey RK, Kumar M, Sharma A, Darlong V, Punj J. Analgesic efficacy of classical thoracolumbar interfascial plane block versus modified thoracolumbar interfascial plane block in patients undergoing lumbar disc surgeries: A comparative, randomised controlled trial. Indian J Anaesth. 2024 Apr;68(4):366-373. doi: 10.4103/ija.ija_1153_23. Epub 2024 Mar 13.
- Results publication: PubMed 35663223Khan MA, Gupta M, Sharma S, Kasaudhan S. A comparative study of ultrasound assisted versus landmark technique for combined spinal-epidural anaesthesia in patients undergoing lower limb orthopaedic surgery. Indian J Anaesth. 2022 Apr;66(4):272-277. doi: 10.4103/ija.ija_775_21. Epub 2022 Apr 20.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Lumbar Disc Surgery, run by Assiut University.
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 5 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: opening soon, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohand Mohamed Fathy Salem (+2 01121482878, Mohanad.16266396@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total opioid consumption (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 NCT06690021, which also lists 6 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 15 Nov 2024.