Ultrasound Guided BlockNCT05999734
Mid-transverse Process to Pleura Block in Pediatric Thoracotomy
A study testing Bupivacaine in people with Ultrasound Guided Block and Pediatric Surgery, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the effectiveness of analgesia of US guided MTP block in pediatrics undergoing thoracotomy. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Ultrasound Guided Block, Pediatric Surgery, Analgesia
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jun 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The study will include 50 pediatric patients of both sexes aged from 5 to 15 years old with American Society of Anesthesiologists physical status I\& II undergoing elective open thoracotomy.
Who cannot join
- Refusal of parents.
- Repeated thoracotomy.
- Emergency surgery.
- Mechanically ventilated patients.
- Bleeding disorders.
- Allergy to study drugs.
- Infection at the site of the needle puncture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Mid-Transverse Process to Pleura Block for Analgesia in Pediatric Thoracotomy: A Randomized Controlled Study
The aim of this study is to assess the effectiveness of analgesia of US guided MTP block in pediatrics undergoing thoracotomy.
Read the detailed description
Pain following surgery is a universal phenomenon which up to now is often underestimated and undertreated especially in pediatrics. Any postoperative analgesic technique should meet three criteria, which are effectiveness, universal applicability and safety.
Thoracotomy is widely known to cause severe acute pain. This pain can be very distressing for both children and their parents. If not treated properly, it may acutely cause ventilation-perfusion disorder and hypoxemia, together with a change in lung mechanics. It may lead to a delay in recovery, with some long-term sequelae. As a part of multimodal analgesia, many regional blocks have been described.
Regional anesthesia techniques are increasingly used in all surgical settings. Even in the context of thoracic surgery, new peripheral regional anesthesia techniques are being tested as alternatives to those already used. This proliferation of new techniques is explained, on the one hand, by the evolution of surgical techniques, which are becoming less and less invasive, and on the other hand, by the frequency and severity of the complications induced by thoracic epidural anesthesia and paravertebral block - currently the gold standards in context of pediatric setting.
Paravertebral block (PVB) has gained more popularity than other regional analgesic techniques including epidural for perioperative analgesia in pediatric surgery. Thoracic PVB provides adequate postoperative analgesia with favorable adverse effects. The use of thoracic PVB is associated with decreased pain severity and opioid consumption in both adults and children.
Many clinicians hesitate to apply the PVB technique due to the risk of serious complications such as pneumothorax. Therefore, the safest and most effective methods are being tried by clinicians. In a study conducted on cadavers claimed that mid-transverse process to pleura (MTP) block (an injection point midway between the pleura and posterior border of the transverse process) provides a paravertebral block due to the paravertebral spread of the local anesthetic agent through fenestrations and septations in the superior costotransverse ligament. They thought that MTP block may be as effective as PVB in postoperative pain management with less risk of possible complications.
- Conditions
- Ultrasound Guided Block, Pediatric Surgery, Analgesia
- Being tested
- Bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Mid transverse process to pleural block
Before skin incision, under complete aseptic precautions and sterilization, the patient will be placed in a lateral position. The spinous process of the fourth thoracic vertebra will be identified and marked. The ultrasound guided MTP block will be done by high frequency linear transducer will be placed in position just lateral to the spinous processes of thoracic vertebra target of the paravertebral space. A 50 mm 22-gauge echogenic needle will be inserted in an in plane technique from a caudal to a cephalad direction and will be advanced. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml normal saline will be injected. Once the needle tip has been confirmed and after careful aspiration to demonstrate the absence of air or blood, 0.5mL/kg 0.25% bupivacaine will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing pediatric thoracotomy will receive general anesthesia alone. | No intervention | the patients will receive general anesthesia alone. Anesthesia will be induced by inhalation of sevoflurane at 8% concentration which will decreased gradually down to 2% concentration carried by 100% oxygen, with loss of consciousness; a peripheral intra venous cannula with suitable size will be inserted, then the neuromuscular blockade will be facilitated by cisatracurium 0.15 mg/ kg to allow tracheal intubation with appropriate sized endotracheal tube. Fentanyl 1μg/ kg will be given and anesthesia will be maintained with air and O2 (50:50) and along with 2% end tidal concentration of sevoflurane to control the depth of anesthesia. At the end of surgery residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes. |
| general anesthesia and ultrasound guided MTP block | Active comparator | midpoint between the transverse process and the pleura 0.5mL/kg 0.25% bupivacaine will be injected. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total dose of morphine consumption in the first postoperative 24 hours.
The total dose of morphine consumption in the first postoperative 24 hours.
Measured: 24 hours postoperative
Secondary outcomes (3)
Pain will be assessed by the face, legs, activity, cry and consolability (FLACC) score in children at 1, 2, 6, 12, 18 and 24 hours postoperative.
Pain will be assessed by the face, legs, activity, cry and consolability (FLACC) score in children at 1, 2, 6, 12, 18 and 24 hours postoperative.The scale is scored in a range of 0 to 10 with 0 representing no pain, 10 representing the maxim
Measured: 1, 2, 6, 12, 18 and 24 hours postoperative.
Total intraoperative fentanyl consumption (μ/kg) starting from induction of anesthesia till the end of surgery.
Total intraoperative fentanyl consumption (μ/kg) starting from induction of anesthesia till the end of surgery.
Measured: from induction of anesthesia till the end of surgery.
Diaphragmatic excursion will be measured preoperative and postoperative in post anesthesia care unit (PACU).
Diaphragmatic excursion will be measured preoperative and postoperative in post anesthesia care unit (PACU).
Measured: Immediately 15 minutes preoperative and 15 minutes postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jan 2024
- Primary completion1 Aug 2024
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Guided 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Salah Eldin Gawish, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999734
- Sponsor's protocol ID
- MTP block
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Mid-Transverse Process to Pleura Block for Analgesia in Pediatric Thoracotomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05999734
- Acronym / sponsor ID
- MTP block
- Conditions
- Ultrasound Guided Block, Pediatric Surgery, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 21 Aug 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 aim of this study is to assess the effectiveness of analgesia of US guided MTP block in pediatrics undergoing thoracotomy.
Detailed description
Pain following surgery is a universal phenomenon which up to now is often underestimated and undertreated especially in pediatrics. Any postoperative analgesic technique should meet three criteria, which are effectiveness, universal applicability and safety.
Thoracotomy is widely known to cause severe acute pain. This pain can be very distressing for both children and their parents. If not treated properly, it may acutely cause ventilation-perfusion disorder and hypoxemia, together with a change in lung mechanics. It may lead to a delay in recovery, with some long-term sequelae. As a part of multimodal analgesia, many regional blocks have been described.
Regional anesthesia techniques are increasingly used in all surgical settings. Even in the context of thoracic surgery, new peripheral regional anesthesia techniques are being tested as alternatives to those already used. This proliferation of new techniques is explained, on the one hand, by the evolution of surgical techniques, which are becoming less and less invasive, and on the other hand, by the frequency and severity of the complications induced by thoracic epidural anesthesia and paravertebral block - currently the gold standards in context of pediatric setting.
Paravertebral block (PVB) has gained more popularity than other regional analgesic techniques including epidural for perioperative analgesia in pediatric surgery. Thoracic PVB provides adequate postoperative analgesia with favorable adverse effects. The use of thoracic PVB is associated with decreased pain severity and opioid consumption in both adults and children.
Many clinicians hesitate to apply the PVB technique due to the risk of serious complications such as pneumothorax. Therefore, the safest and most effective methods are being tried by clinicians. In a study conducted on cadavers claimed that mid-transverse process to pleura (MTP) block (an injection point midway between the pleura and posterior border of the transverse process) provides a paravertebral block due to the paravertebral spread of the local anesthetic agent through fenestrations and septations in the superior costotransverse ligament. They thought that MTP block may be as effective as PVB in postoperative pain management with less risk of possible complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing pediatric thoracotomy will receive general anesthesia alone. | No intervention | –the patients will receive general anesthesia alone. Anesthesia will be induced by inhalation of sevoflurane at 8% concentration which will decreased gradually down to 2% concentration carried by 100% oxygen, with loss of consciousness; a peripheral intra venous cannula with suitable size will be inserted, then the neuromuscular blockade will be facilitated by cisatracurium 0.15 mg/ kg to allow tracheal intubation with appropriate sized endotracheal tube. Fentanyl 1μg/ kg will be given and anesthesia will be maintained with air and O2 (50:50) and along with 2% end tidal concentration of sevoflurane to control the depth of anesthesia. At the end of surgery residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes. |
| general anesthesia and ultrasound guided MTP block | Active comparator | Drug: Bupivacainemidpoint between the transverse process and the pleura 0.5mL/kg 0.25% bupivacaine will be injected. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The study will include 50 pediatric patients of both sexes aged from 5 to 15 years old with American Society of Anesthesiologists physical status I\& II undergoing elective open thoracotomy.
Key exclusion criteria (7 listed)
- Refusal of parents.
- Repeated thoracotomy.
- Emergency surgery.
- Mechanically ventilated patients.
- Bleeding disorders.
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 |
|---|---|---|
| BupivacaineAlso: Mid transverse process to pleural blockBefore skin incision, under complete aseptic precautions and sterilization, the patient will be placed in a lateral position. The spinous process of the fourth thoracic vertebra will be identified and marked. The ultrasound guided MTP block will be done by high frequency linear transducer will be placed in position just lateral to the spinous processes of thoracic vertebra target of the paravertebral space. A 50 mm 22-gauge echogenic needle will be inserted in an in plane technique from a caudal to a cephalad direction and will be advanced. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml normal saline will be injected. Once the needle tip has been confirmed and after careful aspiration to demonstrate the absence of air or blood, 0.5mL/kg 0.25% bupivacaine will be injected. | Drug | general anesthesia and ultrasound guided MTP block |
Primary outcome
The total dose of morphine consumption in the first postoperative 24 hours.
Time frame: 24 hours postoperative
The total dose of morphine consumption in the first postoperative 24 hours.
3 secondary outcomes
Pain will be assessed by the face, legs, activity, cry and consolability (FLACC) score in children at 1, 2, 6, 12, 18 and 24 hours postoperative.
Time frame: 1, 2, 6, 12, 18 and 24 hours postoperative.
Total intraoperative fentanyl consumption (μ/kg) starting from induction of anesthesia till the end of surgery.
Time frame: from induction of anesthesia till the end of surgery.
Diaphragmatic excursion will be measured preoperative and postoperative in post anesthesia care unit (PACU).
Time frame: Immediately 15 minutes preoperative and 15 minutes 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 22 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine in people with Ultrasound Guided Block and Pediatric Surgery, 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 1 inclusion and 7 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 22 Jul 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?
The total dose of morphine consumption in the first postoperative 24 hours. (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 22 Jul 2026.