ThoracotomyNCT05238688
Efficacy of Ipsilateral High Thoracic Ultrasound-guided Erector Spinae Plane Block in Thoracic Cancer Surgeries
A study testing Thoracic Epidural Analgesia (TEA) group and Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group in people with Thoracotomy and Erector Spinae Plane Block, run by Cairo University at 1 site in Egypt.
Trial summary
To evaluate the effectiveness of ultrasound guided Erector Spinae Plane Block (ESPB) in controlling post thoracotomy ipsilateral shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thoracotomy, Erector Spinae Plane Block, Thoracic Cancer
- What is being tested?
- Thoracic Epidural Analgesia (TEA) group and Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2022to 1 Aug 2023
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status class I and II.
- Age ≥ 18 and ≤ 60 Years.
- Patients undergoing thoracic surgery e.g.: metastatectomy, lobectomy, pneumonectomy or pleuro-pneumonectomy.
Who cannot join
- Patient refusal.
- Local infection at the puncture site.
- Coagulopathy with the international normalized ratio (INR) ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities and deficiency of factor II) - acquired (e.g. impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency \& therapeutic anticoagulants drugs).
- Unstable cardiovascular disease.
- History of psychiatric and cognitive disorders.
- Patients allergic to medication used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Ipsilateral High Thoracic Ultrasound-guided Erector Spinae Plane Block in Preventing Post-thoracotomy Shoulder Pain in Thoracic Cancer Surgeries: A Prospective Randomized Controlled Study
To evaluate the effectiveness of ultrasound guided Erector Spinae Plane Block (ESPB) in controlling post thoracotomy ipsilateral shoulder pain.
Read the detailed description
The aim of thoracotomy surgery is to explore the thoracic cavity and manage different pathologies including pulmonary, diaphragmatic, mediastinal, esophageal and vascular pathologies. It can be performed posterolaterally, anterolaterally or even anteriorly.
Post-thoracotomy Ipsilateral Shoulder Pain could undermine pain management in the post-thoracotomy patient.
Erector spinae plane block is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016. It is an inter-fascial plane block, but it may be classified as a paraspinal block due to its mechanism of action and injection site. It has been reported for a variety of indications, as in thoracic neuropathic pain and in postoperative analgesia after major open abdominal surgery. Erector spinae plane block has been successfully used to treat chronic shoulder pain, and the local anesthetic spread was reported to reach the level of C3 when it was performed at T2.
Ultrasound imaging made the practice of regional anesthesia easier in visualization and identification of usual and unusual position of nerves, blood vessels, needle during its passage through the tissues, as well as deposition and spread of local anesthetics in the desired plane and around the desired nerve.
- Being tested
- Thoracic Epidural Analgesia (TEA) group, Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Epidural Analgesia (TEA) groupProcedure or surgery
Under full aseptic conditions while the patient is in setting position, skin infiltration will be done with 2 ml of 1% lidocaine an 18-G Tuohy needle with a 20-G catheter (Perifix, B.Braun, Germany) will be inserted through the T6-T7 interspace, and the epidural space located using the loss of resistance technique. The catheter then advanced approximately 3 cm cephalic. A test dose of 3 ml of 1% lidocaine containing epinephrine in a ratio of 1:200,000 administered to detect unintentional intrathecal . After negative response, 15 ml of 0.25% epidural bupivacine will be injected and the patient will be turned to the supine position.
Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) groupProcedure or surgery
Thoracic Epidural Analgesia will be done at first. Then, the ultrasound probe will be placed longitudinally 2-3 cm lateral to the T2 spinous process in the sagittal line. The T2 spinous process will be identified by counting down anatomically from the vertebral prominens (C7), and the T2 transverse process will be visualized by counting down from the first rib via real-time ultrasound guidance. The erector spinae muscle will be visualized above the T2 transverse process. The needle will be inserted in a caudal cranial direction using the in-plane technique. A dose of 5 mL normal saline will be injected into the inter-fascial area between the erector spinae muscle and the transverse process for the correction of the injection site (hydro-dissection). After hydro-dissection, 15 mL of 0.25% bupivacaine will be injected here, and the linear spread of the solution will be visualized in the inter-fascial plane.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Epidural Analgesia (TEA) group | Experimental | Patients in this group will receive Thoracic Epidural analgesia. Receives: Procedure: Thoracic Epidural Analgesia (TEA) group |
| Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group | Experimental | Patients in this group will receive Thoracic Epidural analgesia in addition to high thoracic ultrasound-guided erector spinae plane block (ESPB). Receives: Procedure: Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with ipsilateral shoulder pain.
Percentage of patients with ipsilateral shoulder pain with a Visual Analogue Scale (VAS) ≥ 3 where (0 = no pain and 10 = severe pain) in the first postoperative hour.
Measured: one hour postoperatively
Secondary outcomes (6)
Time to first rescue analgesia
Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg)
Measured: 24 hours postoperatively
Changes in postoperative heart rate
Heart rate will be recorded before block performance and before induction of anesthesia, intraoperatively every 10 min till the end of surgery and after surgery at T (30 min in Post-Anesthesia Care Unit (PACU), 2, 4, 6, 12, 24 hours).
Measured: Preoperatively, intraoperatively, and 24 hours postoperatively
Changes in postoperative in mean arterial blood pressure
Mean arterial blood pressure will be recorded before block performance and before induction of anesthesia, intraoperatively every 10 min till the end of surgery and after surgery at T (30 min in Post-Anesthesia Care Unit (PACU), 2, 4, 6, 12, 24 hours).
Measured: Preoperatively, intraoperatively, and 24 hours postoperatively.
Total intra-operative fentanyl consumption.
In case of an elevation of heart rate or mean arterial blood pressure ≥ 20% of the baseline will be treated by fentanyl 0.5 μg / kg.
Measured: intraoperatively
Changes in postoperative oxygen saturation
Mean oxygen saturation at predetermined time intervals (1, 2, 6, 12 and 24 hours).
Measured: 24 hours postoperatively
Complications occurrence
Adverse events as bradycardia, hypotension, failed block, local anesthetic toxicity, drowsiness and dizziness.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start12 Aug 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Mahmoud Sami Salahaldin Megahed, Cairo University
- Investigators
- Muhammad Megahed, MSc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238688
- Sponsor's protocol ID
- AP2109-30108
- Status last verified
- Feb 2024
- First submitted
- 3 Feb 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will be available upon a reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Ipsilateral High Thoracic Ultrasound-guided Erector Spinae Plane Block in Preventing Post-thoracotomy Shoulder Pain in Thoracic Cancer Surgeries: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05238688
- Acronym / sponsor ID
- AP2109-30108
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 14 Feb 2022 (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.
To evaluate the effectiveness of ultrasound guided Erector Spinae Plane Block (ESPB) in controlling post thoracotomy ipsilateral shoulder pain.
Detailed description
The aim of thoracotomy surgery is to explore the thoracic cavity and manage different pathologies including pulmonary, diaphragmatic, mediastinal, esophageal and vascular pathologies. It can be performed posterolaterally, anterolaterally or even anteriorly.
Post-thoracotomy Ipsilateral Shoulder Pain could undermine pain management in the post-thoracotomy patient.
Erector spinae plane block is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016. It is an inter-fascial plane block, but it may be classified as a paraspinal block due to its mechanism of action and injection site. It has been reported for a variety of indications, as in thoracic neuropathic pain and in postoperative analgesia after major open abdominal surgery. Erector spinae plane block has been successfully used to treat chronic shoulder pain, and the local anesthetic spread was reported to reach the level of C3 when it was performed at T2.
Ultrasound imaging made the practice of regional anesthesia easier in visualization and identification of usual and unusual position of nerves, blood vessels, needle during its passage through the tissues, as well as deposition and spread of local anesthetics in the desired plane and around the desired nerve.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Epidural Analgesia (TEA) group | Experimental | Procedure: Thoracic Epidural Analgesia (TEA) groupPatients in this group will receive Thoracic Epidural analgesia. |
| Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group | Experimental | Procedure: Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) groupPatients in this group will receive Thoracic Epidural analgesia in addition to high thoracic ultrasound-guided erector spinae plane block (ESPB). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status class I and II.
- Age ≥ 18 and ≤ 60 Years.
- Patients undergoing thoracic surgery e.g.: metastatectomy, lobectomy, pneumonectomy or pleuro-pneumonectomy.
Key exclusion criteria (6 listed)
- Patient refusal.
- Local infection at the puncture site.
- Coagulopathy with the international normalized ratio (INR) ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities and deficiency of factor II) - acquired (e.g. impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency \& therapeutic anticoagulants drugs).
- Unstable cardiovascular disease.
- History of psychiatric and cognitive 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 |
|---|---|---|
| Thoracic Epidural Analgesia (TEA) groupUnder full aseptic conditions while the patient is in setting position, skin infiltration will be done with 2 ml of 1% lidocaine an 18-G Tuohy needle with a 20-G catheter (Perifix, B.Braun, Germany) will be inserted through the T6-T7 interspace, and the epidural space located using the loss of resistance technique. The catheter then advanced approximately 3 cm cephalic. A test dose of 3 ml of 1% lidocaine containing epinephrine in a ratio of 1:200,000 administered to detect unintentional intrathecal . After negative response, 15 ml of 0.25% epidural bupivacine will be injected and the patient will be turned to the supine position. | Procedure or surgery | Thoracic Epidural Analgesia (TEA) group |
| Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) groupThoracic Epidural Analgesia will be done at first. Then, the ultrasound probe will be placed longitudinally 2-3 cm lateral to the T2 spinous process in the sagittal line. The T2 spinous process will be identified by counting down anatomically from the vertebral prominens (C7), and the T2 transverse process will be visualized by counting down from the first rib via real-time ultrasound guidance. The erector spinae muscle will be visualized above the T2 transverse process. The needle will be inserted in a caudal cranial direction using the in-plane technique. A dose of 5 mL normal saline will be injected into the inter-fascial area between the erector spinae muscle and the transverse process for the correction of the injection site (hydro-dissection). After hydro-dissection, 15 mL of 0.25% bupivacaine will be injected here, and the linear spread of the solution will be visualized in the inter-fascial plane. | Procedure or surgery | Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group |
Primary outcome
Percentage of patients with ipsilateral shoulder pain.
Time frame: one hour postoperatively
Percentage of patients with ipsilateral shoulder pain with a Visual Analogue Scale (VAS) ≥ 3 where (0 = no pain and 10 = severe pain) in the first postoperative hour.
6 secondary outcomes
Time to first rescue analgesia
Time frame: 24 hours postoperatively
Changes in postoperative heart rate
Time frame: Preoperatively, intraoperatively, and 24 hours postoperatively
Changes in postoperative in mean arterial blood pressure
Time frame: Preoperatively, intraoperatively, and 24 hours postoperatively.
Total intra-operative fentanyl consumption.
Time frame: intraoperatively
Changes in postoperative oxygen saturation
Time frame: 24 hours postoperatively
Complications occurrence
Time frame: 24 hours 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 7 Feb 2024.
- Individual participant dataSharing planned: Yes. This study will be available upon a reasonable request from the corresponding author.
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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.
Muhammad Megahed, MSc 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 Thoracic Epidural Analgesia (TEA) group and Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group in people with Thoracotomy and Erector Spinae Plane Block, 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 3 inclusion and 6 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 7 Feb 2024. 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?
Percentage of patients with ipsilateral shoulder pain. (time frame: one hour 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 7 Feb 2024.