ThoracotomyPhase 2/3thoracotomyNCT06831578
Compare the Perioperative Analgesic Effect of Ultrasound Guided Thoracic Paravertebral Block and Ultrasound Guided Serratus Anterior Block in Patients Undergoing Thoracotomy
A Phase 2/3 study testing seratuse anterior plane block and paravertebral plane block in people with Thoracotomy and Thoracotomy Analgesia, run by Menoufia University at 2 sites in Egypt.
Trial summary
The aim of this study is to compare the perioperative analgesic effect of ultrasound guided thoracic paravertebral block and ultrasound guided serratus anterior block in patients undergoing thoracotomy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Thoracotomy, Thoracotomy Analgesia
- What is being tested?
- seratuse anterior plane block and paravertebral plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Dec 2023to 10 Feb 2025
- Phase
- Phase 2/3
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- : Patients 20 to 60 years old
- ASA physical status of class II and III.
Who cannot join
- Patients with severe respiratory disease
- preexisting neurologic deficit
- allergy to any of the study drug
- kypho-scoliosis
- presence of local infection
- on current chronic analgesic therapy, having history of opioid dependence'
Show all 9Show fewer
- patient refusal
- inablity to communicate with the investigators
- who will require postoperative mechanical ventilation .
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Menoufia university hospital
Shebeen Elkom, Menoufia
Menoufia faculty of medicine hospital
Shebin Elkom
About this study
Official title: Analgesic Efficacy of Ultrasound-guided Serratus Anterior Plane Block Versus Thoracic Paravertebral Plane Block in Patients Undergoing Thoracotomy
The aim of this study is to compare the perioperative analgesic effect of ultrasound guided thoracic paravertebral block and ultrasound guided serratus anterior block in patients undergoing thoracotomy.
Read the detailed description
randomized, comparative study General anesthesia will be conducted
- Conditions
- Thoracotomy, Thoracotomy Analgesia
- Being tested
- seratuse anterior plane block, paravertebral plane block
- Keywords
- analgesia, thoracotomy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seratuse anterior plane blockProcedure or surgery
after patient consenting, induction of anathesia Under sterile conditions, and while the patients will be still on the lateral position with the diseased side up after induction of anesthesia, a linear ultrasound transducer (10-12 MHz) will be placed in a sagittal plane over the mid-clavicular region of the thoracic cage. Then counting down ribs till the seventh rib will be identified in the mid-axillar]y line. The following muscles will be identified overlying the sixth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). The needle (22-G, 50-mm Touhy needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane deep to the serratus anterior muscle . Under continuous ultrasound guidance, 20 ml of 0.25% bupivacaine will be injected then a catheter will be threaded. A continuous infusion of 5 ml/hr of 0.125% bupivacaine will be then started through the catheter.
paravertebral plane blockProcedure or surgery
after concenting patient, induction of anathesia Paravertebral plan block will be performed while the patient is still in lateral position and a linear ultrasound transducer (10-12 MHz) will be used for ultrasound guidance. A sagittal or transverse image can be obtained at the appropriate vertebral level. After image optimization, the Tuohy needle is advanced in plane until the tip rests in the thoracic paravertebral space. Injection of small amounts of fluid (hydrodissection) will aid in needle tip location. Saline or local anesthetic is injected through the Tuohy needle. The endpoint for a successful block is anterior displacement of the pleura. 20 ml of 0.25% bupivacaine will be injected then a catheter will be threaded. A continuous infusion of 5 ml/hr of 0.125% bupivacaine will be then started through the catheter. The catheter is threaded through the Tuohy needle and its position is confirmed by injecting local anesthetic or small air bubbles. Pleural depression should agai
| Study group | Role | What they receive |
|---|---|---|
| serratus anterior plane block | Active comparator | Not described Receives: Procedure: seratuse anterior plane block |
| paravertebral plane block | Active comparator | Not described Receives: Procedure: paravertebral plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
with the use of the visual analouge scale (VAS) in the preoperative visit. Where 0 score as no pain and 10 as the worst imaginable pain.
Measured: postoperative up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start10 Dec 2023
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracotomyStudies of the same condition, open and under way.
- More trials run by Menoufia 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Consenting patients will be assigned randomly (1:1) into two groups. Both groups will receive general anesthesia and after induction an ultrasound guided serratu anterior plan block will be performed for one group and an ultrasound guided paravertebral plan block will be performed for the other. In both groups a loading dose of the local anesthetic (LA) solution( 20 ml of 0.25% bupivacaine ) will be injected before the surgical procedure
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohamed Hamza Sedky, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831578
- Sponsor's protocol ID
- 10/2024 ANESTH
- Acronym
- thoracotomy
- Status last verified
- May 2024
- First submitted
- 9 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ultrasound-guided Serratus Anterior Plane Block Versus Thoracic Paravertebral Plane Block in Patients Undergoing Thoracotomy
- ClinicalTrials.gov ID
- NCT06831578
- Acronym / sponsor ID
- thoracotomy / 10/2024 ANESTH
- Conditions
- Thoracotomy, Thoracotomy Analgesia
- Keywords
- analgesia, thoracotomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 18 Feb 2025 (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 perioperative analgesic effect of ultrasound guided thoracic paravertebral block and ultrasound guided serratus anterior block in patients undergoing thoracotomy.
Detailed description
randomized, comparative study General anesthesia will be conducted
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Consenting patients will be assigned randomly (1:1) into two groups. Both groups will receive general anesthesia and after induction an ultrasound guided serratu anterior plan block will be performed for one group and an ultrasound guided paravertebral plan block will be performed for the other. In both groups a loading dose of the local anesthetic (LA) solution( 20 ml of 0.25% bupivacaine ) will be injected before the surgical procedure
| Arm | Type | Receives |
|---|---|---|
| serratus anterior plane block | Active comparator | Procedure: seratuse anterior plane block |
| paravertebral plane block | Active comparator | Procedure: paravertebral plane block |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- : Patients 20 to 60 years old
- ASA physical status of class II and III.
Key exclusion criteria (9 listed)
- Patients with severe respiratory disease
- preexisting neurologic deficit
- allergy to any of the study drug
- kypho-scoliosis
- presence of local infection
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 |
|---|---|---|
| seratuse anterior plane blockafter patient consenting, induction of anathesia Under sterile conditions, and while the patients will be still on the lateral position with the diseased side up after induction of anesthesia, a linear ultrasound transducer (10-12 MHz) will be placed in a sagittal plane over the mid-clavicular region of the thoracic cage. Then counting down ribs till the seventh rib will be identified in the mid-axillar]y line. The following muscles will be identified overlying the sixth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). The needle (22-G, 50-mm Touhy needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane deep to the serratus anterior muscle . Under continuous ultrasound guidance, 20 ml of 0.25% bupivacaine will be injected then a catheter will be threaded. A continuous infusion of 5 ml/hr of 0.125% bupivacaine will be then started through the catheter. | Procedure or surgery | serratus anterior plane block |
| paravertebral plane blockafter concenting patient, induction of anathesia Paravertebral plan block will be performed while the patient is still in lateral position and a linear ultrasound transducer (10-12 MHz) will be used for ultrasound guidance. A sagittal or transverse image can be obtained at the appropriate vertebral level. After image optimization, the Tuohy needle is advanced in plane until the tip rests in the thoracic paravertebral space. Injection of small amounts of fluid (hydrodissection) will aid in needle tip location. Saline or local anesthetic is injected through the Tuohy needle. The endpoint for a successful block is anterior displacement of the pleura. 20 ml of 0.25% bupivacaine will be injected then a catheter will be threaded. A continuous infusion of 5 ml/hr of 0.125% bupivacaine will be then started through the catheter. The catheter is threaded through the Tuohy needle and its position is confirmed by injecting local anesthetic or small air bubbles. Pleural depression should agai | Procedure or surgery | paravertebral plane block |
Primary outcome
postoperative pain
Time frame: postoperative up to 24 hours
with the use of the visual analouge scale (VAS) in the preoperative visit. Where 0 score as no pain and 10 as the worst imaginable pain.
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 18 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing seratuse anterior plane block and paravertebral plane block in people with Thoracotomy and Thoracotomy Analgesia, run by Menoufia University at 2 sites 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 2 inclusion and 9 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 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
postoperative pain (time frame: postoperative up to 24 hours). 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 18 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.