Mid-Transverse Process BlockNCT06331143
Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion
A study testing Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block and Morphine in people with Mid-Transverse Process Block and Intrathecal Morphine, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the analgesic efficacy of mid-transverse process to pleura (MTP) block and intrathecal morphine in idiopathic scoliosis patients undergoing posterior spinal fusion surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mid-Transverse Process Block, Intrathecal Morphine, Idiopathic Scoliosis
- What is being tested?
- Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block and Morphine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Mar 2024to 4 Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Idiopathic scoliosis patients undergoing posterior spinal fusion surgery.
Who cannot join
- Patient with morbid obesity (body mass index >40 kg/m2).
- Patients with pre-existing infection at block site.
- Known allergy to study drugs.
- Coagulation disorder.
- History of psychiatric illness.
- Pre-existing neurological deficits.
- Presence of any pre-operative pain or history of chronic pain.
- History of regular analgesic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion: A Randomized Clinical Trial
The aim of this study is to compare the analgesic efficacy of mid-transverse process to pleura (MTP) block and intrathecal morphine in idiopathic scoliosis patients undergoing posterior spinal fusion surgery.
Read the detailed description
The postoperative period for idiopathic scoliosis patients undergoing posterior spinal fusion (PSF) is fraught with challenges, including adequate postoperative pain control and prolonged hospitalization.
Intrathecal opioids have been used to manage postoperative pain in pediatric patients for a wide variety of surgeries , including adolescent and adult PSF. Multimodal analgesic (MMA) regimens using several drugs and techniques are considered to be necessary for postoperative pain relief.
The mid-transverse process to pleura (MTP) block was first described as a modified paravertebral block in 2017. The local anesthetics (LAs) are administered between the transverse process and the pleura. This results in a LA spread to the dorsal and ventral rami in the paravertebral space through the fenestrations in the superior costotransverse ligament at the level of injection, and frequently to adjacent levels.
- Conditions
- Mid-Transverse Process Block, Intrathecal Morphine, Idiopathic Scoliosis, Posterior Spinal Fusion
- Being tested
- Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block, Morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) BlockDevice
Patients will receive MTP block after induction of anesthesia.
MorphineDrug
Patients will receive intrathecal morphine in a dose of 12 μg/kg (max 1000 μg) immediately after induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Mid-Transverse Process block (MTP) group | Experimental | Patients will receive mid-transverse process to pleura (MTP) block after induction of anesthesia. Receives: Device: Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block |
| Intrathecal morphine (IM) group | Experimental | Patients will receive intrathecal morphine in a dose of 12 μg/kg (max 1000 μg) immediately after induction of anesthesia. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Degree of pain will be assessed by the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
It will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.
Measured: 24 hours postoperative
Secondary outcomes (4)
Heart rate
Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
Measured: Till the end of surgery.
Mean arterial pressure
Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
Measured: Till the end of surgery.
Patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
It will be assessed 24 hours after surgery.
Measured: 24 hours postoperative.
Complications
Complications such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication.
Measured: 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start28 Mar 2024
- Primary completion4 Jan 2026
- Study completion4 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid-Transverse Process BlockStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
- Investigators
- Mohammed S ElSharkawy, MD, Principal investigator, Faculty of Medicine, Tanta University, Tanta, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331143
- Sponsor's protocol ID
- 36264PR551/2/24
- Status last verified
- Jan 2026
- First submitted
- 17 Mar 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06331143
- Acronym / sponsor ID
- 36264PR551/2/24
- Conditions
- Mid-Transverse Process Block, Intrathecal Morphine, Idiopathic Scoliosis, Posterior Spinal Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 4 Jan 2026 (actual)
- Study completion
- 4 Jan 2026 (actual)
- First posted
- 26 Mar 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.
The aim of this study is to compare the analgesic efficacy of mid-transverse process to pleura (MTP) block and intrathecal morphine in idiopathic scoliosis patients undergoing posterior spinal fusion surgery.
Detailed description
The postoperative period for idiopathic scoliosis patients undergoing posterior spinal fusion (PSF) is fraught with challenges, including adequate postoperative pain control and prolonged hospitalization.
Intrathecal opioids have been used to manage postoperative pain in pediatric patients for a wide variety of surgeries , including adolescent and adult PSF. Multimodal analgesic (MMA) regimens using several drugs and techniques are considered to be necessary for postoperative pain relief.
The mid-transverse process to pleura (MTP) block was first described as a modified paravertebral block in 2017. The local anesthetics (LAs) are administered between the transverse process and the pleura. This results in a LA spread to the dorsal and ventral rami in the paravertebral space through the fenestrations in the superior costotransverse ligament at the level of injection, and frequently to adjacent levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mid-Transverse Process block (MTP) group | Experimental | Device: Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) BlockPatients will receive mid-transverse process to pleura (MTP) block after induction of anesthesia. |
| Intrathecal morphine (IM) group | Experimental | Drug: MorphinePatients will receive intrathecal morphine in a dose of 12 μg/kg (max 1000 μg) immediately after induction of anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Idiopathic scoliosis patients undergoing posterior spinal fusion surgery.
Key exclusion criteria (8 listed)
- Patient with morbid obesity (body mass index >40 kg/m2).
- Patients with pre-existing infection at block site.
- Known allergy to study drugs.
- Coagulation disorder.
- History of psychiatric illness.
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 |
|---|---|---|
| Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) BlockPatients will receive MTP block after induction of anesthesia. | Device | Mid-Transverse Process block (MTP) group |
| MorphinePatients will receive intrathecal morphine in a dose of 12 μg/kg (max 1000 μg) immediately after induction of anesthesia. | Drug | Intrathecal morphine (IM) group |
Primary outcome
Degree of pain
Time frame: 24 hours postoperative
Degree of pain will be assessed by the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). It will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.
4 secondary outcomes
Heart rate
Time frame: Till the end of surgery.
Mean arterial pressure
Time frame: Till the end of surgery.
Patient satisfaction
Time frame: 24 hours postoperative.
Complications
Time frame: 24 hours postoperative.
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 29 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
Mohammed S ElSharkawy, MD principal investigator
Faculty of Medicine, Tanta University, Tanta, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block and Morphine in people with Mid-Transverse Process Block and Intrathecal Morphine, 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 4 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 29 Jan 2026. 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?
Degree of pain (time frame: 24 hours postoperative). 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 29 Jan 2026.