Post-thoracotomy Pain SyndromeNCT04531553
Erector Spinae Plane Block for Post-thoracotomy Pain Control
A study testing Thoracic epidural analgesia, ESPB with levobupivacaine and dexmedetomedine and ESPB with levobupivacaine in people with Post-thoracotomy Pain Syndrome, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
The thoracic epidural block (TEB) and thoracic paravertebral block (TPVB) are the most commonly used techniques for analgesia after thoracic surgery.Recently, erector spinae plane block (ESPB) was reported as a treatment for thoracic neuropathic pain.Dexmedetomidine has been primarily used for intra- venous sedation… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-thoracotomy Pain Syndrome
- What is being tested?
- Thoracic epidural analgesia, ESPB with levobupivacaine and dexmedetomedine and ESPB with levobupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2021to 15 Jun 2022
- 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
- Physical status ASA I and II.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
- Patient undergoing thoracotomy for cancer surgery (Lobectomy, Pneumonectomy, and Decortication).
Who cannot join
- Patient refusal
- Known sensitivity or contraindication to local anesthetics or dexmedetomidine.
- History of psychological disorders.
- Localized infection at the site of block.
- Coagulopathies with platelet count below 50,000 or an INR>1.5.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia and Pain medicine.National Cancer Institute
Cairo, 11796
About this study
Official title: The Impact of Ultrasound-Guided Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in the Management of Acute and Chronic Post-Thoracotomy Pain: A Randomized, Controlled Study
The thoracic epidural block (TEB) and thoracic paravertebral block (TPVB) are the most commonly used techniques for analgesia after thoracic surgery.Recently, erector spinae plane block (ESPB) was reported as a treatment for thoracic neuropathic pain.Dexmedetomidine has been primarily used for intra- venous sedation in intensive care settings. The unique analgesic properties of dexmedetomidine have encouraged the anesthesiologists to use it perineurally.
This study aims to evaluate the effect ultrasound erector spinae plane block with dexmedetomidine infusion in management of acute and chronic post thoracotomy pain.
Read the detailed description
The thoracic epidural block (TEB) and thoracic paravertebral block (TPVB) are the most commonly used techniques for analgesia after thoracic surgery. However, TEA has several adverse effects, such as hypotension, motor blockade, hematoma, and abscess and TPVB has a chance of epidural spread and pneumothorax, and multiple injections are needed if more than 4 dermatome analgesia is required. Recently, erector spinae plane block (ESPB) was reported as a treatment for thoracic neuropathic pain.
ESPB is a relatively simple technique with easily identified sonographic landmarks, and a catheter is easily inserted into the plane after distention induced by the injection. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade.
The selectivity of dexmedetomidine to the α2-receptors is eight times of its prototype, clonidine. Accordingly, dexmedetomidine is a more powerful sedative and analgesic drug than clonidine with less hemodynamic derangements from the α1-receptor activation. Dexmedetomidine has been primarily used for intra- venous sedation in intensive care settings. The unique analgesic properties of dexmedetomidine have encouraged the anesthesiologists to use it perineurally. Previous studies have declared that dexmedetomidine potentiates local anesthetic effect when administered by neuroaxial route.
This study aims to evaluate the effect ultrasound erector spinae plane block with dexmedetomidine infusion in management of acute and chronic post thoracotomy pain.
- Conditions
- Post-thoracotomy Pain Syndrome
- Being tested
- Thoracic epidural analgesia, ESPB with levobupivacaine and dexmedetomedine, ESPB with levobupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic epidural analgesiaProcedure or surgery
Patients will preoperatively receive thoracic epidural at the level T5 \& T6 with bolus 20 ml of levobupivacaine 0.25% then levobupivacaine 0.1% infused at a rate of 0.1 mL/Kg/hr until chest tube removal ( 5-6 days).
ESPB with levobupivacaine and dexmedetomedineProcedure or surgery
patients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% plus 0.5mic/Kg dexmedetomidine on the deep aspect of erector spinae muscle then catheter inserted. 20 ml bolus of levobupivacaine 0.1% with dexmedetomidine 0.5 μg/Kg was injected every 6 hours until chest tube removal.
ESPB with levobupivacaineProcedure or surgery
patients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% on the deep aspect of erector spinae muscle then catheter inserted.A 20 ml bolus of levobupivacaine 0.1% is injected every 6 hours until chest tube removal.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic epidural analgesia | Active comparator | Patients will preoperatively receive thoracic epidural at the level T5 \& T6 with bolus 20 ml of levobupivacaine 0.25% then levobupivacaine 0.1% infused at a rate of 0.1 mL/Kg/h until chest tube removal ( 5-6 days). Receives: Procedure: Thoracic epidural analgesia |
| ESPB with levobupivacaine | Active comparator | patients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% on the deep aspect of erector spinae muscle then catheter inserted.A 20 ml bolus of levobupivacaine 0.1% is injected every 6 hours until chest tube removal. Receives: Procedure: ESPB with levobupivacaine |
| ESPB with levobupivacaine and dexmedetomidine | Active comparator | patients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% plus 0.5mic/Kg dexmedetomidine on the deep aspect of erector spinae muscle then catheter inserted. 20 ml bolus of levobupivacaine 0.1% with dexmedetomidine 0.5 μg/Kg was injected every 6 hours until chest tube removal. Receives: Procedure: ESPB with levobupivacaine and dexmedetomedine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity score
measurement of Visual analogue score in a line 0 to 100 , where 0 indicates no pain and 100 indicates the worst pain.
Measured: 1 week
Secondary outcomes (1)
Number of patients who will develop post-thoracotomy pain syndrome.
Reporting the emergence of post-thoracotomy pain syndrome in all the studied patients.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start3 Mar 2021
- Primary completion28 May 2022
- Study completion15 Jun 2022
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Hanafy Shaker, National Cancer Institute, Egypt
- Investigators
- Ehab H Gendy, MD, Principal investigator, Assistant Professor of Anesthesia, intensive care and pain releif
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531553
- Sponsor's protocol ID
- ESPB for PTPS
- Status last verified
- Jul 2022
- First submitted
- 25 Aug 2020
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After submitting the paper authors are planning to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ultrasound-Guided Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in the Management of Acute and Chronic Post-Thoracotomy Pain: A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT04531553
- Acronym / sponsor ID
- ESPB for PTPS
- Conditions
- Post-thoracotomy Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 28 Aug 2020 (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 thoracic epidural block (TEB) and thoracic paravertebral block (TPVB) are the most commonly used techniques for analgesia after thoracic surgery.Recently, erector spinae plane block (ESPB) was reported as a treatment for thoracic neuropathic pain.Dexmedetomidine has been primarily used for intra- venous sedation in intensive care settings. The unique analgesic properties of dexmedetomidine have encouraged the anesthesiologists to use it perineurally.
This study aims to evaluate the effect ultrasound erector spinae plane block with dexmedetomidine infusion in management of acute and chronic post thoracotomy pain.
Detailed description
The thoracic epidural block (TEB) and thoracic paravertebral block (TPVB) are the most commonly used techniques for analgesia after thoracic surgery. However, TEA has several adverse effects, such as hypotension, motor blockade, hematoma, and abscess and TPVB has a chance of epidural spread and pneumothorax, and multiple injections are needed if more than 4 dermatome analgesia is required. Recently, erector spinae plane block (ESPB) was reported as a treatment for thoracic neuropathic pain.
ESPB is a relatively simple technique with easily identified sonographic landmarks, and a catheter is easily inserted into the plane after distention induced by the injection. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade.
The selectivity of dexmedetomidine to the α2-receptors is eight times of its prototype, clonidine. Accordingly, dexmedetomidine is a more powerful sedative and analgesic drug than clonidine with less hemodynamic derangements from the α1-receptor activation. Dexmedetomidine has been primarily used for intra- venous sedation in intensive care settings. The unique analgesic properties of dexmedetomidine have encouraged the anesthesiologists to use it perineurally. Previous studies have declared that dexmedetomidine potentiates local anesthetic effect when administered by neuroaxial route.
This study aims to evaluate the effect ultrasound erector spinae plane block with dexmedetomidine infusion in management of acute and chronic post thoracotomy pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thoracic epidural analgesia | Active comparator | Procedure: Thoracic epidural analgesiaPatients will preoperatively receive thoracic epidural at the level T5 \& T6 with bolus 20 ml of levobupivacaine 0.25% then levobupivacaine 0.1% infused at a rate of 0.1 mL/Kg/h until chest tube removal ( 5-6 days). |
| ESPB with levobupivacaine | Active comparator | Procedure: ESPB with levobupivacainepatients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% on the deep aspect of erector spinae muscle then catheter inserted.A 20 ml bolus of levobupivacaine 0.1% is injected every 6 hours until chest tube removal. |
| ESPB with levobupivacaine and dexmedetomidine | Active comparator | Procedure: ESPB with levobupivacaine and dexmedetomedinepatients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% plus 0.5mic/Kg dexmedetomidine on the deep aspect of erector spinae muscle then catheter inserted. 20 ml bolus of levobupivacaine 0.1% with dexmedetomidine 0.5 μg/Kg was injected every 6 hours until chest tube removal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Physical status ASA I and II.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
- Patient undergoing thoracotomy for cancer surgery (Lobectomy, Pneumonectomy, and Decortication).
Key exclusion criteria (5 listed)
- Patient refusal
- Known sensitivity or contraindication to local anesthetics or dexmedetomidine.
- History of psychological disorders.
- Localized infection at the site of block.
- Coagulopathies with platelet count below 50,000 or an INR>1.5.
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 analgesiaPatients will preoperatively receive thoracic epidural at the level T5 \& T6 with bolus 20 ml of levobupivacaine 0.25% then levobupivacaine 0.1% infused at a rate of 0.1 mL/Kg/hr until chest tube removal ( 5-6 days). | Procedure or surgery | Thoracic epidural analgesia |
| ESPB with levobupivacaine and dexmedetomedinepatients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% plus 0.5mic/Kg dexmedetomidine on the deep aspect of erector spinae muscle then catheter inserted. 20 ml bolus of levobupivacaine 0.1% with dexmedetomidine 0.5 μg/Kg was injected every 6 hours until chest tube removal. | Procedure or surgery | ESPB with levobupivacaine and dexmedetomidine |
| ESPB with levobupivacainepatients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% on the deep aspect of erector spinae muscle then catheter inserted.A 20 ml bolus of levobupivacaine 0.1% is injected every 6 hours until chest tube removal. | Procedure or surgery | ESPB with levobupivacaine |
Primary outcome
Pain intensity score
Time frame: 1 week
measurement of Visual analogue score in a line 0 to 100 , where 0 indicates no pain and 100 indicates the worst pain.
1 secondary outcome
Number of patients who will develop post-thoracotomy pain syndrome.
Time frame: 3 months
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 2 Aug 2022.
- Individual participant dataSharing planned: No. After submitting the paper authors are planning to share IPD
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.
Ehab H Gendy, MD principal investigator
Assistant Professor of Anesthesia, intensive care and pain releif
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, ESPB with levobupivacaine and dexmedetomedine and ESPB with levobupivacaine in people with Post-thoracotomy Pain Syndrome, run by National Cancer Institute, Egypt 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 5 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 2 Aug 2022. 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?
Pain intensity score (time frame: 1 week). 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 2 Aug 2022.