Post-thoracotomy Pain SyndromeNCT05409144
Impact of Thoracic Epidural Versus Serratus Anterior Plane Block Versus Erector Spinae Plane Block on Incidence of PTPS
A study testing Thoracic epidural infusion, Erector Spinae Plane Block and Serratus Anterior Plane Block in people with Post-thoracotomy Pain Syndrome and Erector Spinae Plane Block, run by National Cancer Institute, Egypt.
Trial summary
The aim of this study is to evaluate the impact of Ultrasound-guided Erector Spinae plane block compared to Ultrasound-guided serratus anterior plane block on the emergence of post-thoracotomy pain syndrome in patients undergoing lobectomy for lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-thoracotomy Pain Syndrome, Erector Spinae Plane Block, Serratus Anterior Plane Block
- What is being tested?
- Thoracic epidural infusion, Erector Spinae Plane Block and Serratus Anterior Plane Block
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2022to 1 Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age (18-65) Years
- Physical status American Society of Anesthesiologists Classification II, III
- Patients undergoing lobectomy through lateral thoracotomy
- Body mass index (BMI): (20-40) kg/m2
Who cannot join
- Patient refusal.
- Age <18 years or >65 years
- Body mass index (BMI) <20 kg/m2 and >40 kg/m2
- Known sensitivity or contraindication to drugs used in the study
- Contraindication to regional anesthesia e.g. local infection at site of introduction, pre-existing peripheral neuropathies and coagulopathy.
- Pregnancy.
Show all 13Show fewer
- Physical status American Society of Anesthesiologists Classification IV
- patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
- patients with a history of drug abuse
- patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
- patients with a history of thoracic surgery through lateral thoracotomy; and patients with recurrent chest malignancies within 3 months.
- All patients who developed severe intra- or post-operative bleeding or required postoperative mechanical ventilation were also excluded from the study.
- Thoracic spine disorders or deformity.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Thoracic Epidural Infusion Versus Continuous Serratus Anterior Plane Block Versus Continuous Erector Spinae Plane Block on Incidence of Post Thoracotomy Pain Syndrome: A Randomized Controlled Trial
The aim of this study is to evaluate the impact of Ultrasound-guided Erector Spinae plane block compared to Ultrasound-guided serratus anterior plane block on the emergence of post-thoracotomy pain syndrome in patients undergoing lobectomy for lung cancer.
Read the detailed description
Lung cancer has the highest incidence of all malignancies worldwide and accounts for approximately 13% of all cancer cases. Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the main therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing as is the incidence of post-thoracotomy pain. In addition to amputation and mastectomy, thoracotomy is considered the main etiology of severe and long-term acute and chronic post-surgical pain syndromes (CPSPs). The prevalence of post-thoracotomy pain syndrome (PTPS) is widely variable (30%-50%) and may range from 11% to 80%, according to other studies.
The International Association for the Study of Pain (IASP) has defined post-thoracotomy pain syndrome as "pain that recurs or persists along the thoracotomy scar at least 2 months after the procedure". In addition, post-thoracotomy pain syndrome is mostly described with neuropathic manifestations along the thoracotomy scar and in the mammary, inframammary, ipsilateral scapular and interscapular areas.
The ultrasound-guided erector spinae plane (ESP) block is a novel technique for thoracic analgesia that promises to be a relatively simple and safe alternative to more complex and invasive techniques of neural blockade.
- Being tested
- Thoracic epidural infusion, Erector Spinae Plane Block, Serratus Anterior Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic epidural infusionProcedure or surgery
Upon locating the desired site spot, lidocaine 1% must be injected into the skin and underlying tissues to decrease the discomfort with the advancement of the epidural needle. Once achieving local anesthesia, the epidural needle advanced with its stylet in place and with its bevel point cephalad; this will ultimately contribute to the proper location of the epidural catheter. The epidural needle must be advanced through the skin, subcutaneous tissue, supraspinous, and interspinous ligaments. Once there, the stylet must be removed, and the Loss of Resistance syringe (filled up with saline, air, or both) must be attached to the needle. The needle must be advanced while applying pressure to the plunger. Once the ligamentum flavum is pierced, a loss in resistance will be noted; this is the epidural space, and 5 to 10 cc of saline is injected to expand the epidural space; this may decrease the risk of vascular injury.
Erector Spinae Plane BlockDevice
The block-level will be at T5. The ultrasound probe will be placed on the back in a transverse orientation to identify the tip of the T5 transverse process; these are recognizable as flat, squared-off acoustic shadows with only a very faint image of the pleura visible. The tip of the transverse process will be centered on the ultrasound screen and the probe will then be rotated into a longitudinal orientation to produce a parasagittal view, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius, erector spinae muscle and T5 transverse process. 3ml lidocaine 1% will be used on skin and subcutaneous fat, Echogenic block needle will be inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T5 transverse process.
Serratus Anterior Plane BlockDevice
The block is performed with full aseptic precautions. Arm abduction is preferred. The ultrasound probe will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, with the indicator oriented toward the operator's left. With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, then, 3ml lidocaine 1% will be used for skin and subcutaneous fat, using ultrasound guidance, a 38-mm 22-gauge regional block needle is going to be advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid intravascular injection 30ml of levobupivacaine 0.25% will be injected anteriorly to the rib and deep into the serratus anterior muscle.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic epidural infusion group | Experimental | Patients will receive thoracic epidural preoperative Receives: Procedure: Thoracic epidural infusion |
| Erector Spinae Plane Block group | Experimental | Patients will receive Ultrasound-guided Erector Spinae Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25% and insertion of a catheter Receives: Device: Erector Spinae Plane Block |
| Serratus Anterior Plane Block group | Experimental | Patients will receive Ultrasound-guided Serratus Anterior Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25%. Receives: Device: Serratus Anterior Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients developing post-thoracotomy pain syndrome
The incidence of patients developing post-thoracotomy pain syndrome according to grading system for neuropathic pain (GSNP
Measured: 12 weeks postoperatively
Secondary outcomes (11)
Morphine consumption
The total amount of morphine consumed postoperatively for 48 hours.
Measured: 48 hours Postoperatively
Fentanyl consumption
Total amount of fentanyl consumed intraoperative
Measured: Intraoperatively
Post-thoracotomy pain syndrome severity
Severity of Post-thoracotomy pain syndrome according to Grading system for neuropathic pain (GSNP)
Measured: 12 weeks postoperatively
Patient's Quality of life
Patient's Quality of life according to the Flanagan Quality of Life Scale (QOLS)
Measured: 12 weeks postoperatively
Postoperative Patient's activity level
Postoperative Patient's activity level according to Barthel Activities of Daily Living scale (ADL)
Measured: 12 weeks postoperatively
Heart rate
Heart rate will be recorded
Measured: Intraoperatively
Mean arterial blood pressure
Mean arterial blood pressure will be recorded
Measured: Intraoperatively
Nausea and vomiting
Postoperative nausea and vomiting (PONV) will be recorded
Measured: 24 hours postopertivley
Post-operative pain
Post-operative pain will be assessed by the Numeric Rating Scale (NRS)
Measured: 24 hours postopratively
Time taken till 1st rescue analgesic request
The time till administration of first rescue analgesia will be recorded
Measured: 24 hours postopratively
Postoperative pulmonary complications
Postoperative pulmonary complications will be recorded
Measured: 24 hours postopratively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start20 Jun 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-thoracotomy Pain SyndromeStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Shaban Mohammed, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409144
- Sponsor's protocol ID
- AP2202-30106
- Status last verified
- Jun 2022
- First submitted
- 3 Jun 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available under a reasonable request from the author
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Thoracic Epidural Infusion Versus Continuous Serratus Anterior Plane Block Versus Continuous Erector Spinae Plane Block on Incidence of Post Thoracotomy Pain Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05409144
- Acronym / sponsor ID
- AP2202-30106
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 20 Jun 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 8 Jun 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.
The aim of this study is to evaluate the impact of Ultrasound-guided Erector Spinae plane block compared to Ultrasound-guided serratus anterior plane block on the emergence of post-thoracotomy pain syndrome in patients undergoing lobectomy for lung cancer.
Detailed description
Lung cancer has the highest incidence of all malignancies worldwide and accounts for approximately 13% of all cancer cases. Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the main therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing as is the incidence of post-thoracotomy pain. In addition to amputation and mastectomy, thoracotomy is considered the main etiology of severe and long-term acute and chronic post-surgical pain syndromes (CPSPs). The prevalence of post-thoracotomy pain syndrome (PTPS) is widely variable (30%-50%) and may range from 11% to 80%, according to other studies.
The International Association for the Study of Pain (IASP) has defined post-thoracotomy pain syndrome as "pain that recurs or persists along the thoracotomy scar at least 2 months after the procedure". In addition, post-thoracotomy pain syndrome is mostly described with neuropathic manifestations along the thoracotomy scar and in the mammary, inframammary, ipsilateral scapular and interscapular areas.
The ultrasound-guided erector spinae plane (ESP) block is a novel technique for thoracic analgesia that promises to be a relatively simple and safe alternative to more complex and invasive techniques of neural blockade.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thoracic epidural infusion group | Experimental | Procedure: Thoracic epidural infusionPatients will receive thoracic epidural preoperative |
| Erector Spinae Plane Block group | Experimental | Device: Erector Spinae Plane BlockPatients will receive Ultrasound-guided Erector Spinae Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25% and insertion of a catheter |
| Serratus Anterior Plane Block group | Experimental | Device: Serratus Anterior Plane BlockPatients will receive Ultrasound-guided Serratus Anterior Plane Block preoperative with an injection of 30 ml levobupivacaine 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)
- Age (18-65) Years
- Physical status American Society of Anesthesiologists Classification II, III
- Patients undergoing lobectomy through lateral thoracotomy
- Body mass index (BMI): (20-40) kg/m2
Key exclusion criteria (13 listed)
- Patient refusal.
- Age <18 years or >65 years
- Body mass index (BMI) <20 kg/m2 and >40 kg/m2
- Known sensitivity or contraindication to drugs used in the study
- Contraindication to regional anesthesia e.g. local infection at site of introduction, pre-existing peripheral neuropathies and coagulopathy.
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 infusionUpon locating the desired site spot, lidocaine 1% must be injected into the skin and underlying tissues to decrease the discomfort with the advancement of the epidural needle. Once achieving local anesthesia, the epidural needle advanced with its stylet in place and with its bevel point cephalad; this will ultimately contribute to the proper location of the epidural catheter. The epidural needle must be advanced through the skin, subcutaneous tissue, supraspinous, and interspinous ligaments. Once there, the stylet must be removed, and the Loss of Resistance syringe (filled up with saline, air, or both) must be attached to the needle. The needle must be advanced while applying pressure to the plunger. Once the ligamentum flavum is pierced, a loss in resistance will be noted; this is the epidural space, and 5 to 10 cc of saline is injected to expand the epidural space; this may decrease the risk of vascular injury. | Procedure or surgery | Thoracic epidural infusion group |
| Erector Spinae Plane BlockThe block-level will be at T5. The ultrasound probe will be placed on the back in a transverse orientation to identify the tip of the T5 transverse process; these are recognizable as flat, squared-off acoustic shadows with only a very faint image of the pleura visible. The tip of the transverse process will be centered on the ultrasound screen and the probe will then be rotated into a longitudinal orientation to produce a parasagittal view, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius, erector spinae muscle and T5 transverse process. 3ml lidocaine 1% will be used on skin and subcutaneous fat, Echogenic block needle will be inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T5 transverse process. | Device | Erector Spinae Plane Block group |
| Serratus Anterior Plane BlockThe block is performed with full aseptic precautions. Arm abduction is preferred. The ultrasound probe will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, with the indicator oriented toward the operator's left. With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, then, 3ml lidocaine 1% will be used for skin and subcutaneous fat, using ultrasound guidance, a 38-mm 22-gauge regional block needle is going to be advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid intravascular injection 30ml of levobupivacaine 0.25% will be injected anteriorly to the rib and deep into the serratus anterior muscle. | Device | Serratus Anterior Plane Block group |
Primary outcome
Incidence of patients developing post-thoracotomy pain syndrome
Time frame: 12 weeks postoperatively
The incidence of patients developing post-thoracotomy pain syndrome according to grading system for neuropathic pain (GSNP
11 secondary outcomes
Morphine consumption
Time frame: 48 hours Postoperatively
Fentanyl consumption
Time frame: Intraoperatively
Post-thoracotomy pain syndrome severity
Time frame: 12 weeks postoperatively
Patient's Quality of life
Time frame: 12 weeks postoperatively
Postoperative Patient's activity level
Time frame: 12 weeks postoperatively
Heart rate
Time frame: Intraoperatively
Mean arterial blood pressure
Time frame: Intraoperatively
Nausea and vomiting
Time frame: 24 hours postopertivley
Post-operative pain
Time frame: 24 hours postopratively
Time taken till 1st rescue analgesic request
Time frame: 24 hours postopratively
Postoperative pulmonary complications
Time frame: 24 hours postopratively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: Yes. The data will be available under a reasonable request from the author
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.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic epidural infusion, Erector Spinae Plane Block and Serratus Anterior Plane Block in people with Post-thoracotomy Pain Syndrome and Erector Spinae Plane Block, run by National Cancer Institute, 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 13 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: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abdelfattah, M.Sc (1222332541 ext. +20, Dr.ahmed.sha3ban@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients developing post-thoracotomy pain syndrome (time frame: 12 weeks 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 8 Jun 2022.