Lung CancerNCT06618599
Mid-transverse Process Combined With Erector Spinae Block Versus Paravertebral Plane Block
A study testing Mid-transverse process to pleura block combined with erector spinae block and paravertebral block in people with Lung Cancer, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare efficacy of Mid-transverse process to pleura block combined with erector spinae block versus paravertebral plane block in cancer patients undergoing thoracotomy surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Mid-transverse process to pleura block combined with erector spinae block and paravertebral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Jan 2027
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lung cancer patients for thoracotomy surgeries.
- Physical status American Society of Anesthesiologists (ASA )II, III.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2
Who cannot join
- Patient refusal
- physical status ASA IV,
- Age \<18 years or \>65 years
- BMI \< 20 kg/m2 and \>35 kg/m2
- Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
- History of psychological disorders and/or chronic pain.
- Contraindication to regional anesthesia e.g., local sepsis, pre- existing peripheral neuropathies, and coagulopathy.
- Severe respiratory, cardiac, hepatic or renal disease.
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
Cairo University
Cairo, 11835
sayed M abed, MD degree, +201226806532, sydabed2020@outlook.com
About this study
Official title: Analgesic Effect of Mid-transverse Process to Pleura Block Combined With Erector Spinae Block Versus Paravertebral Plane Block in Thoracic Surgery for Lung Cancer Patients
This study aims to compare efficacy of Mid-transverse process to pleura block combined with erector spinae block versus paravertebral plane block in cancer patients undergoing thoracotomy surgeries.
Read the detailed description
Thoracic paravertebral block (TPVB) application has also been used in recent years due to the lower incidence of side effects. The erector spinae plane block (ESPB)has been used as a part of multimodal analgesia in recent years. In ESPB is aimed to treat the postoperative pain of the thoracoabdominal region by injecting a local anesthetic into the interfacial area under the erector spinae muscle . ESPB creates an effect that covers the posterior and lateral thorax by affecting the dorsal rami and branches of the spinal nerves . Midtransverse process to pleura (MTP) block is less invasive as the position of the needle in this block is midway between the transverse process' posterior border and the pleura. Due to fenestrations present in the superior costotransverse ligament (SCTL), the drug reaches the paravertebral space
- Conditions
- Lung Cancer
- Being tested
- Mid-transverse process to pleura block combined with erector spinae block, paravertebral block
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mid-transverse process to pleura block combined with erector spinae blockProcedure or surgery
The probe will be placed vertically 3 cm lateral to the T5 spinous process and the transverse process will be identified. The needle will be introduced in an in-plane fashion until the tip lay deep in the erector spinae muscle. One milliliter of normal saline will be injected to confirm the correct needle tip position by visualizing the spread under the erector spinae muscle. 20 mL of 0.25% bupivacaine will be injected .The needle will be directed aiming for the midpoint between the transverse process and pleura from cephalad to caudad. One milliliter of normal saline will be given to confirm the position of the needle tip, then a total of 20 ml of 0.25% ropivacaine will be injected
paravertebral blockProcedure or surgery
the transducer will be positioned laterally 3 cm to the midline at T5 spinous process, defining the spinous process, pleura, transverse process, the paravertebral (PV) space, and superior costotransverse ligament. The trapezius, rhomboid major, and erector spinae muscles will be recognized as superficial to the hyperechoic transverse process shadow. However, when the rhomboid major muscle disappeared, this indicated that we will be at the 7th thoracic vertebra's level. Local infiltration using 2-3 mL of 2.0% lignocaine will be done. A spinal 22-gauge needle will be injected at the cephalic side of the transducer using an in-plane technique, and the needle directed towards the costotransverse ligament (CTL). The passage of the needle through the CTL will be associated with a pop, informing that the superior costotransverse ligament will be passed. Following a 3 mL testing dose of normal saline containing epinephrine (1:200,000), 30 mL bupivacaine 0.25% injected.
| Study group | Role | What they receive |
|---|---|---|
| Group 1:midtransverse to pleura block combined with erector spinae block | Experimental | Patients received ipsilateral Ultrasound guided midtransverse block with injection of 20 ml bupivacaine 0.25% and ipsilateral Ultrasound guided ESPB block with injection of 20 ml bupivacaine 0.25% Receives: Procedure: Mid-transverse process to pleura block combined with erector spinae block |
| Group 2: paravertebral block | Experimental | Patients received ipsilateral Ultrasound guided paravertebral plane block with injection of 30 ml bupivacaine 0.25%. Receives: Procedure: paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue score changes during rest and cough for the three groups.
the score of visual analogue score, with minimum score of 0 and maximum of 10, with higher scores meaning more severe pain
Measured: for 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 posted1 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
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 Lung CancerStudies 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
- Model description
- Group 1: received ipsilateral Ultrasound guided midtransverse block and ipsilateral Ultrasound guided ESPB block Group 2: paravertebral block(PVB): Patients received ipsilateral Ultrasound guided paravertebral plane block .
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Mahmoud Abed, Cairo University
- Investigators
- sayed M Abed, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618599
- Sponsor's protocol ID
- analgesia in thoracotomy
- Status last verified
- Aug 2026
- First submitted
- 26 Sep 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: starting from march 2025
Publications
Zengin M, Alagoz A. Comparison of Thoracic Epidural Analgesia and Thoracic Paravertebral Block Applications in the Treatment of Acute Pain After Thoracotomy in Geriatric Patients. Cureus. 2021 Oct 22;13(10):e18982. doi: 10.7759/cureus.18982. eCollection 2021 Oct.
PubMed 34820237Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
PubMed 26509324Liu L, Ni XX, Zhang LW, Zhao K, Xie H, Zhu J. Effects of ultrasound-guided erector spinae plane block on postoperative analgesia and plasma cytokine levels after uniportal VATS: a prospective randomized controlled trial. J Anesth. 2021 Feb;35(1):3-9. doi: 10.1007/s00540-020-02848-x. Epub 2020 Sep 4.
PubMed 32886200
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Mid-transverse Process to Pleura Block Combined With Erector Spinae Block Versus Paravertebral Plane Block in Thoracic Surgery for Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT06618599
- Acronym / sponsor ID
- analgesia in thoracotomy
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Oct 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.
This study aims to compare efficacy of Mid-transverse process to pleura block combined with erector spinae block versus paravertebral plane block in cancer patients undergoing thoracotomy surgeries.
Detailed description
Thoracic paravertebral block (TPVB) application has also been used in recent years due to the lower incidence of side effects. The erector spinae plane block (ESPB)has been used as a part of multimodal analgesia in recent years. In ESPB is aimed to treat the postoperative pain of the thoracoabdominal region by injecting a local anesthetic into the interfacial area under the erector spinae muscle . ESPB creates an effect that covers the posterior and lateral thorax by affecting the dorsal rami and branches of the spinal nerves . Midtransverse process to pleura (MTP) block is less invasive as the position of the needle in this block is midway between the transverse process' posterior border and the pleura. Due to fenestrations present in the superior costotransverse ligament (SCTL), the drug reaches the paravertebral space
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Group 1: received ipsilateral Ultrasound guided midtransverse block and ipsilateral Ultrasound guided ESPB block Group 2: paravertebral block(PVB): Patients received ipsilateral Ultrasound guided paravertebral plane block .
| Arm | Type | Receives |
|---|---|---|
| Group 1:midtransverse to pleura block combined with erector spinae block | Experimental | Procedure: Mid-transverse process to pleura block combined with erector spinae blockPatients received ipsilateral Ultrasound guided midtransverse block with injection of 20 ml bupivacaine 0.25% and ipsilateral Ultrasound guided ESPB block with injection of 20 ml bupivacaine 0.25% |
| Group 2: paravertebral block | Experimental | Procedure: paravertebral blockPatients received ipsilateral Ultrasound guided paravertebral plane block with injection of 30 ml bupivacaine 0.25%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- lung cancer patients for thoracotomy surgeries.
- Physical status American Society of Anesthesiologists (ASA )II, III.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2
Key exclusion criteria (8 listed)
- Patient refusal
- physical status ASA IV,
- Age \<18 years or \>65 years
- BMI \< 20 kg/m2 and \>35 kg/m2
- Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
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 |
|---|---|---|
| Mid-transverse process to pleura block combined with erector spinae blockThe probe will be placed vertically 3 cm lateral to the T5 spinous process and the transverse process will be identified. The needle will be introduced in an in-plane fashion until the tip lay deep in the erector spinae muscle. One milliliter of normal saline will be injected to confirm the correct needle tip position by visualizing the spread under the erector spinae muscle. 20 mL of 0.25% bupivacaine will be injected .The needle will be directed aiming for the midpoint between the transverse process and pleura from cephalad to caudad. One milliliter of normal saline will be given to confirm the position of the needle tip, then a total of 20 ml of 0.25% ropivacaine will be injected | Procedure or surgery | Group 1:midtransverse to pleura block combined with erector spinae block |
| paravertebral blockthe transducer will be positioned laterally 3 cm to the midline at T5 spinous process, defining the spinous process, pleura, transverse process, the paravertebral (PV) space, and superior costotransverse ligament. The trapezius, rhomboid major, and erector spinae muscles will be recognized as superficial to the hyperechoic transverse process shadow. However, when the rhomboid major muscle disappeared, this indicated that we will be at the 7th thoracic vertebra's level. Local infiltration using 2-3 mL of 2.0% lignocaine will be done. A spinal 22-gauge needle will be injected at the cephalic side of the transducer using an in-plane technique, and the needle directed towards the costotransverse ligament (CTL). The passage of the needle through the CTL will be associated with a pop, informing that the superior costotransverse ligament will be passed. Following a 3 mL testing dose of normal saline containing epinephrine (1:200,000), 30 mL bupivacaine 0.25% injected. | Procedure or surgery | Group 2: paravertebral block |
Primary outcome
visual analogue score changes during rest and cough for the three groups.
Time frame: for 24 hours postoperative
the score of visual analogue score, with minimum score of 0 and maximum of 10, with higher scores meaning more severe pain
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 1 Sep 2026.
- Background: PubMed 34820237Zengin M, Alagoz A. Comparison of Thoracic Epidural Analgesia and Thoracic Paravertebral Block Applications in the Treatment of Acute Pain After Thoracotomy in Geriatric Patients. Cureus. 2021 Oct 22;13(10):e18982. doi: 10.7759/cureus.18982. eCollection 2021 Oct.
- Background: PubMed 26509324Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
- Background: PubMed 32886200Liu L, Ni XX, Zhang LW, Zhao K, Xie H, Zhu J. Effects of ultrasound-guided erector spinae plane block on postoperative analgesia and plasma cytokine levels after uniportal VATS: a prospective randomized controlled trial. J Anesth. 2021 Feb;35(1):3-9. doi: 10.1007/s00540-020-02848-x. Epub 2020 Sep 4.
- https://jag.journalagent.com/scie/pdfs/SCIE-68926-RESEARCH\_ARTICLE-BUKAGIKIRAN.pdfLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. starting from march 2025
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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.
sayed M Abed 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 Mid-transverse process to pleura block combined with erector spinae block and paravertebral block in people with Lung Cancer, 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 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: looking for participants now, as of the sponsor's last update on 1 Sep 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?
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 sayed M abed, MD degree (+201226806532, sydabed2020@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue score changes during rest and cough for the three groups. (time frame: for 24 hours postoperative). 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 NCT06618599, 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 1 Sep 2026.