Post Thoracotomy PainESPvsTPVBNCT07437027
Analgesic Efficiency of Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Patients Undergoing Lateral Thoracotomy Using Opoid Sparing Anesthesia
A study testing Group A :Thoracic paravertebral block and Erector Spinae Plane Block in people with Post Thoracotomy Pain, run by Cairo University at 1 site in Egypt.
Trial summary
AimoftheWork To assess the efficiency of Opoid free anaesthesia with paravertebral block compared to opoid free anaesthesia with erector spinae plane block in patients undergoing Thoracotomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Thoracotomy Pain
- What is being tested?
- Group A :Thoracic paravertebral block and Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Jul 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age between 18 and 70 .
- Patients with ASAII and IIIstatus.
- Patients undergoing open surgical Thoracotomy as in lobectomy, pneumonectomy, segmentectomy and decortication.
- Gender both males and females.
- 2.Exclusioncriteria
- Refusal of the patient.
Show all 11Show fewer
- Allergy to local anesthetic
- Infection of the skin at the site of local infiltration
- Cardiovascular problems (arrhythmia, heart block, SVT,AF, multiple extra systole).
- Any contraindication to regional anesthesia as coagulopathy
- Patients with chronic pain or on opoid medication preoperative
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eman Mamdouh Mahmoud Hussien (emanmmh), Assistant lecturer contact
About this study
Official title: Analgesic Efficiency of Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Patients Undergoing Lateral Thoracotomy Using Opoid Sparing Anesthesia . A Comparative Study
AimoftheWork To assess the efficiency of Opoid free anaesthesia with paravertebral block compared to opoid free anaesthesia with erector spinae plane block in patients undergoing Thoracotomy.
Read the detailed description
There is growing evidence showing that opoid-free anesthesia (OFA), including loco-regional anesthesia and non-opioid drugs, is feasible in several surgical settings. The surgeries for pathologies involving the lungs and mediastinum involves different types of thoracic surgical incision such as anterolateral or posterolateral.
Post thoracotomy pain affects 30%-50% of the patients undergoing thoracotomy.Poorly managed pain following thoracotomy can lead to increase the risk of complications such as lung collapse and chest infections due to altered mechanical functions of the lungs and ventilation-perfusion mismatch. 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.
So, Analgesia is a major determinant of balanced anesthesia and it is usually achieved by administering opioid agents, which are well tolerated and maintain hemodynamic stability in the perioperative period. However, perioperative opioid administration is not risk-free. Opioids are associated with life-threatening side effects such as respiratory depression, postoperative nausea and vomiting, opioid-induced hyperalgesia, constipation, urinary retention, immunomodulation and neurotoxicity. In addition, opioid prescription after surgery seems to trigger the development of opioid addiction, thus contributing to the widespread opioid misuse observed worldwide. Several studies found a correlation between postoperative opioid administration, the development of chronic pain and opioid addiction.
Therefore,opioid administration should be reduced or avoided as much as possible.
Thoracic epidural analgesia (TEA) is considered as the gold standard for thoracotomy pain(4)However, according to a recent systematic review, The thoracic paravertebral block (TPVB) has been shown to be as effective as TEA with reduction of the risks of minor complications compared to TEA.
Emerging research has shown that the novel erector spinaeplane block(ESPB) can be employed as a simple and safe alternative analgesic technique for acute postsurgical, post-traumatic, and chronic neuropathic thoracic pain in adults.
The goal of this study is to assess the Analgesic efficiency of erector spinae plane block versus thoracic paravertebral block in patients undergoing lateral thoracotomy using opoid sparing anesthesia.
- Conditions
- Post Thoracotomy Pain
- Being tested
- Group A :Thoracic paravertebral block, Erector Spinae Plane Block
- Keywords
- Opoid free anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A :Thoracic paravertebral blockProcedure or surgery
Ultrasound guided thoracic paravertebral block performed at the T5 level using 20 ml of 0.5% bupivacaine for postoperative analgesia in patients undergoing lateral thoracotomy
Erector Spinae Plane BlockProcedure or surgery
ultrasound guided erector spinae plane block will be performed at the T5 level using 20 ml of 0.5% bupivacaine as part of an opoid sparing anesthesia protocol for lateral thoracotomy
| Study group | Role | What they receive |
|---|---|---|
| Group A : thoracic para vertebral block | Experimental | Patients in this arm will receive ultrasound guided thoracic paravertebral block at the T5 level using 20 ml of 0.5% bupivacaine protocol for lateral thoracotomy Receives: Procedure: Group A :Thoracic paravertebral block |
| Group B : erector spinae plane block | Experimental | Patients in this arm will receive ultrasound guided erector spinae plane block at the T5 level using 20 ml of 0.5% bupivacaine as part of an opoid sparing anesthesia protocol for lateral thoracotomy Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption for the first 24 hours postoperative
Measured: Within the first 24 hours postoperative
Secondary outcomes (1)
Postoperative pain
Postoperative pain will be assessed using vas score at 0,2,6,12,24 hours post operative
Measured: At 0,2,6,12,24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Thoracotomy PainStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohamed Mustafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437027
- Sponsor's protocol ID
- Post thoracotomy pain
- Acronym
- ESPvsTPVB
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Doan LV, Augustus J, Androphy R, Schechter D, Gharibo C. Mitigating the impact of acute and chronic post-thoracotomy pain. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):1048-56. doi: 10.1053/j.jvca.2014.02.021. No abstract available.
PubMed 25107721Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
PubMed 18443635Marshall K, McLaughlin K. Pain Management in Thoracic Surgery. Thorac Surg Clin. 2020 Aug;30(3):339-346. doi: 10.1016/j.thorsurg.2020.03.001. Epub 2020 Apr 29.
PubMed 32593366Mamoun N, Wright MC, Bottiger B, Plichta R, Klinger R, Manning M, Raghunathan K, Gulur P. Pain Trajectories After Valve Surgeries Performed via Midline Sternotomy Versus Mini-Thoracotomy. J Cardiothorac Vasc Anesth. 2022 Sep;36(9):3596-3602. doi: 10.1053/j.jvca.2022.05.007. Epub 2022 May 10.
PubMed 35641410
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficiency of Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Patients Undergoing Lateral Thoracotomy Using Opoid Sparing Anesthesia . A Comparative Study
- ClinicalTrials.gov ID
- NCT07437027
- Acronym / sponsor ID
- ESPvsTPVB / Post thoracotomy pain
- Conditions
- Post Thoracotomy Pain
- Keywords
- Opoid free anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 27 Feb 2026 (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.
AimoftheWork To assess the efficiency of Opoid free anaesthesia with paravertebral block compared to opoid free anaesthesia with erector spinae plane block in patients undergoing Thoracotomy.
Detailed description
There is growing evidence showing that opoid-free anesthesia (OFA), including loco-regional anesthesia and non-opioid drugs, is feasible in several surgical settings. The surgeries for pathologies involving the lungs and mediastinum involves different types of thoracic surgical incision such as anterolateral or posterolateral.
Post thoracotomy pain affects 30%-50% of the patients undergoing thoracotomy.Poorly managed pain following thoracotomy can lead to increase the risk of complications such as lung collapse and chest infections due to altered mechanical functions of the lungs and ventilation-perfusion mismatch. 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.
So, Analgesia is a major determinant of balanced anesthesia and it is usually achieved by administering opioid agents, which are well tolerated and maintain hemodynamic stability in the perioperative period. However, perioperative opioid administration is not risk-free. Opioids are associated with life-threatening side effects such as respiratory depression, postoperative nausea and vomiting, opioid-induced hyperalgesia, constipation, urinary retention, immunomodulation and neurotoxicity. In addition, opioid prescription after surgery seems to trigger the development of opioid addiction, thus contributing to the widespread opioid misuse observed worldwide. Several studies found a correlation between postoperative opioid administration, the development of chronic pain and opioid addiction.
Therefore,opioid administration should be reduced or avoided as much as possible.
Thoracic epidural analgesia (TEA) is considered as the gold standard for thoracotomy pain(4)However, according to a recent systematic review, The thoracic paravertebral block (TPVB) has been shown to be as effective as TEA with reduction of the risks of minor complications compared to TEA.
Emerging research has shown that the novel erector spinaeplane block(ESPB) can be employed as a simple and safe alternative analgesic technique for acute postsurgical, post-traumatic, and chronic neuropathic thoracic pain in adults.
The goal of this study is to assess the Analgesic efficiency of erector spinae plane block versus thoracic paravertebral block in patients undergoing lateral thoracotomy using opoid sparing anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : thoracic para vertebral block | Experimental | Procedure: Group A :Thoracic paravertebral blockPatients in this arm will receive ultrasound guided thoracic paravertebral block at the T5 level using 20 ml of 0.5% bupivacaine protocol for lateral thoracotomy |
| Group B : erector spinae plane block | Experimental | Procedure: Erector Spinae Plane BlockPatients in this arm will receive ultrasound guided erector spinae plane block at the T5 level using 20 ml of 0.5% bupivacaine as part of an opoid sparing anesthesia protocol for lateral thoracotomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients age between 18 and 70 .
- Patients with ASAII and IIIstatus.
- Patients undergoing open surgical Thoracotomy as in lobectomy, pneumonectomy, segmentectomy and decortication.
- Gender both males and females.
- 2.Exclusioncriteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Group A :Thoracic paravertebral blockUltrasound guided thoracic paravertebral block performed at the T5 level using 20 ml of 0.5% bupivacaine for postoperative analgesia in patients undergoing lateral thoracotomy | Procedure or surgery | Group A : thoracic para vertebral block |
| Erector Spinae Plane Blockultrasound guided erector spinae plane block will be performed at the T5 level using 20 ml of 0.5% bupivacaine as part of an opoid sparing anesthesia protocol for lateral thoracotomy | Procedure or surgery | Group B : erector spinae plane block |
Primary outcome
Total morphine consumption for the first 24 hours postoperative
Time frame: Within the first 24 hours postoperative
1 secondary outcome
Postoperative pain
Time frame: At 0,2,6,12,24 hours post operative
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 27 Feb 2026.
- Background: PubMed 25107721Doan LV, Augustus J, Androphy R, Schechter D, Gharibo C. Mitigating the impact of acute and chronic post-thoracotomy pain. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):1048-56. doi: 10.1053/j.jvca.2014.02.021. No abstract available.
- Background: PubMed 18443635Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
- Background: PubMed 32593366Marshall K, McLaughlin K. Pain Management in Thoracic Surgery. Thorac Surg Clin. 2020 Aug;30(3):339-346. doi: 10.1016/j.thorsurg.2020.03.001. Epub 2020 Apr 29.
- Results publication: PubMed 35641410Mamoun N, Wright MC, Bottiger B, Plichta R, Klinger R, Manning M, Raghunathan K, Gulur P. Pain Trajectories After Valve Surgeries Performed via Midline Sternotomy Versus Mini-Thoracotomy. J Cardiothorac Vasc Anesth. 2022 Sep;36(9):3596-3602. doi: 10.1053/j.jvca.2022.05.007. Epub 2022 May 10.
- Individual participant dataSharing planned: Undecided
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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.
Eman Mamdouh Mahmoud Hussien (emanmmh), Assistant lecturer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A :Thoracic paravertebral block and Erector Spinae Plane Block in people with Post Thoracotomy Pain, 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 11 inclusion and 0 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: opening soon, as of the sponsor's last update on 27 Feb 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 Eman Mamdouh Mahmoud Hussien (emanmmh), Assistant lecturer (201002087146, Eman.mamdouh31@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption for the first 24 hours postoperative (time frame: Within the first 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 NCT07437027, which also lists 4 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 27 Feb 2026.