Multiple Mid-Transverse Process to PleuraNCT06820190
Analgesic Efficacy of Multiple Mid-Transverse Process to Pleura (MTP) Block and PCA in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion
A study testing Multiple Mid-Transverse Process to Pleura (MTP) Block and Morphine in people with Multiple Mid-Transverse Process to Pleura and PCA, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the analgesic efficacy of multiple mid-transverse process to pleura (MTP) block and PCA 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
- Multiple Mid-Transverse Process to Pleura, PCA, Idiopathic Scoliosis
- What is being tested?
- Multiple Mid-Transverse Process to Pleura (MTP) Block and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2025to 1 Dec 2026
- Phase
- Interventional
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
- Patients with pre-existing infection at block site.
- Known allergy to study drugs.
- Coagulation disorder.
- History of psychiatric illness.
- Pre-existing neurological deficits.
- Patient with morbid obesity (body mass index >40 kg/m2).
- Presence of any pre-operative pain or history of chronic pain.
- History of regular analgesic.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Mohammed S Elsharkawy, MD, 00201148207870, mselsharkawy@med.tanta.edu.eg
Saad A Moharam, MD
About this study
Official title: Comparison of Analgesic Efficacy of Multiple Mid-Transverse Process to Pleura (MTP) Block and PCA in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion: A Randomized Clinical Trial
This study aims to compare the analgesic efficacy of multiple mid-transverse process to pleura (MTP) block and PCA 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.
Regional anesthesia techniques, mainly epidural analgesia and, more recently, paravertebral blocks, became crucial parts of the multimodal analgesia (MMA) regimen after introducing ultrasound (US) in the regional anesthesia practice. Erector spinae plane (ESP) block and mid-transverse to pleura (MTP) block are the latest developments in postoperative pain therapy.
- Conditions
- Multiple Mid-Transverse Process to Pleura, PCA, Idiopathic Scoliosis, Posterior Spinal Fusion
- Being tested
- Multiple 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.
Multiple Mid-Transverse Process to Pleura (MTP) BlockOther
Patients will receive multiple mid-transverse process to pleura (MTP) block after induction of anesthesia.
MorphineDrug
Also called PCA
Patients will receive IV-PCA. Morphine is generally administered as an initial loading dose of 0.05-0.1 mg/kg before the end of surgery, with PCA settings of a bolus dose of 0.01-0.03 mg/kg, a lockout interval of 6-10 min, and a background infusion of 0.01-0.02 mg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| MTP group | Experimental | Patients will receive multiple mid-transverse process to pleura (MTP) block after induction of anesthesia. Receives: Other: Multiple Mid-Transverse Process to Pleura (MTP) Block |
| PCA group | Experimental | Patients will receive IV-PCA. Morphine is generally administered as an initial loading dose of 0.05-0.1 mg/kg before the end of surgery, with PCA settings of a bolus dose of 0.01-0.03 mg/kg, a lockout interval of 6-10 min, and a background infusion of 0.01-0.02 mg/kg/h. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
The degree of pain will be assessed using the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.
Measured: 24 hours postoperatively
Secondary outcomes (7)
Intraoperative fentanyl consumption
Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
Measured: Intraoperatively
Time to the first request for the rescue analgesia
Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).
Measured: 24 hours postoperatively
Total morphine consumption
Postoperative analgesia was provided by morphine (3 mg IV in Multiple Mid-Transverse Process to Pleura (MTP) Block group or 0.01 mg/kg bolus with a 15-min lockout in PCA group) to keep the Visual Analogue Scale (VAS) at rest less than 4.
Measured: 24 hours postoperatively
Mean arterial pressure
Mean arterial pressure will be recorded preoperatively, before the block is performed, and every 15 minutes until the end of the surgery.
Measured: Every 15 minutes until the end of the surgery (Up to 2 hours)
Heart rate
Heart rate will be recorded preoperatively, before the block is performed, and every 15 minutes until the end of the surgery.
Measured: Every 15 minutes until the end of the surgery (Up to 2 hours)
Degree of 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 postoperatively
Incidence of complications
Incidence of complications such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start12 Feb 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Mid-Transverse Process to PleuraStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820190
- Sponsor's protocol ID
- 36264PR1047/1/25
- Status last verified
- Jan 2026
- First submitted
- 6 Feb 2025
- Last updated
- 7 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.