External Oblique Intercostal Plane BlockNCT06431880
External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain
A study testing External oblique intercostal plane block and Thoracic paravertebral block in people with External Oblique Intercostal Plane Block and Thoracic Paravertebral Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effectiveness of analgesia achieved by external oblique intercostal plane block (EOIPB)and thoracic paravertebral block (TPVB) for postoperative pain management in patients undergoing open thoracotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- External Oblique Intercostal Plane Block, Thoracic Paravertebral Block, Post Thoracotomy Pain
- What is being tested?
- External oblique intercostal plane block and Thoracic paravertebral block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2024to 1 Jun 2025
- 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-III.
- Scheduled for open thoracotomy
Who cannot join
- Patients with neurological or intellectual disability.
- Infection at the injection site.
- Opioid addiction.
- Allergic reaction to local anesthetics.
- Coagulation abnormalities.
- Drug abuse.
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- Pregnancy.
- Severe liver and/or renal failure.
- Uncontrolled hypertension.
- Severe cardiovascular problems.
- Diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tanta University Hospitals
Tanta, El-Gharbia Governorate, Egypt, 31527
About this study
Official title: External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain: A Randomized Non-inferiority Trial
The aim of this study is to compare the effectiveness of analgesia achieved by external oblique intercostal plane block (EOIPB)and thoracic paravertebral block (TPVB) for postoperative pain management in patients undergoing open thoracotomy.
Read the detailed description
Acute thoracotomy pain is multifactorial in nature. It involves nociceptive and neuropathic mechanisms originating from somatic and visceral afferents. The main sources of pain are intercostal nerves, the vagus nerve and phrenic nerve in the pleura, the superficial cervical plexus, and the brachial plexus in the ipsilateral shoulder.
- Conditions
- External Oblique Intercostal Plane Block, Thoracic Paravertebral Block, Post Thoracotomy Pain
- Being tested
- External oblique intercostal plane block, Thoracic paravertebral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External oblique intercostal plane blockOther
Patients will receive external oblique intercostal plane block
Thoracic paravertebral blockOther
Patients will receive thoracic paravertebral block
| Study group | Role | What they receive |
|---|---|---|
| External oblique intercostal plane block | Experimental | Patients will receive external oblique intercostal plane block. Receives: Other: External oblique intercostal plane block |
| Thoracic paravertebral block | Experimental | Patients will receive thoracic paravertebral block. Receives: Other: Thoracic paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Rescue analgesia of morphine will be given as 2 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the numeric rating scale < 4. numeric rating scale will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.
Measured: 24 hours postoperatively
Secondary outcomes (6)
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: Intraoperative
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
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
Time to the 1st rescue analgesia
All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of morphine will be given as 2 mg bolus if the numeric rating scale > 3 to be repeated after 30 min if pain persists until the numeric rating scale < 4. NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively
Measured: 24 hours postoperatively
Degree of pain
Degree of pain will be measured using numeric rating scale (NRS) (0 represents "no pain" while 10 represents "the worst pain imaginable").NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.
Measured: 24 hours postoperatively
Complications
Complications such as bradycardia, hypotension, nausea, vomiting, respiratory depression, local anesthetic systemic toxicity (LAST) or any other complication will be recorded.
Measured: 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start30 May 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for External Oblique Intercostal Plane 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
- 90 participants (actual)
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
- NCT06431880
- Sponsor's protocol ID
- 36246PR638/4/24
- Status last verified
- Aug 2025
- First submitted
- 16 May 2024
- Last updated
- 19 Aug 2025
- 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 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain: A Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06431880
- Acronym / sponsor ID
- 36246PR638/4/24
- Conditions
- External Oblique Intercostal Plane Block, Thoracic Paravertebral Block, Post Thoracotomy Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 29 May 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 effectiveness of analgesia achieved by external oblique intercostal plane block (EOIPB)and thoracic paravertebral block (TPVB) for postoperative pain management in patients undergoing open thoracotomy.
Detailed description
Acute thoracotomy pain is multifactorial in nature. It involves nociceptive and neuropathic mechanisms originating from somatic and visceral afferents. The main sources of pain are intercostal nerves, the vagus nerve and phrenic nerve in the pleura, the superficial cervical plexus, and the brachial plexus in the ipsilateral shoulder.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External oblique intercostal plane block | Experimental | Other: External oblique intercostal plane blockPatients will receive external oblique intercostal plane block. |
| Thoracic paravertebral block | Experimental | Other: Thoracic paravertebral blockPatients will receive thoracic paravertebral block. |
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-III.
- Scheduled for open thoracotomy
Key exclusion criteria (11 listed)
- Patients with neurological or intellectual disability.
- Infection at the injection site.
- Opioid addiction.
- Allergic reaction to local anesthetics.
- Coagulation abnormalities.
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 |
|---|---|---|
| External oblique intercostal plane blockPatients will receive external oblique intercostal plane block | Other | External oblique intercostal plane block |
| Thoracic paravertebral blockPatients will receive thoracic paravertebral block | Other | Thoracic paravertebral block |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
Rescue analgesia of morphine will be given as 2 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the numeric rating scale < 4. numeric rating scale will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.
6 secondary outcomes
Intraoperative fentanyl consumption
Time frame: Intraoperative
Mean arterial pressure
Time frame: Till the end of surgery
Heart rate
Time frame: Till the end of surgery
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Complications
Time frame: 24 hour postoperatively
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 19 Aug 2025.
- 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.
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 External oblique intercostal plane block and Thoracic paravertebral block in people with External Oblique Intercostal Plane Block and Thoracic Paravertebral Block, 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 11 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 19 Aug 2025. 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?
Total morphine consumption (time frame: 24 hours postoperatively). 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 19 Aug 2025.