Thoracoscopic SurgeriesVATNCT06160375
Erector Spine Plane Block Versus Single-injection Thoracic Paravertebral Block Via Intrathoracic Approach in Single-port Video-assisted Thoracoscopic Lung Surgeries
A study testing pain assessment after video assisted thoracoscopic lung surgeries in people with Thoracoscopic Surgeries, run by Ain Shams University at 1 site in Egypt.
Trial summary
Effect of ultrasound-guided erector spine plane block versus single-injection thoracic paravertebral block via intrathoracic approach in single-port video-assisted thoracoscopic lung surgeries in postoperative analgesia: a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracoscopic Surgeries
- What is being tested?
- pain assessment after video assisted thoracoscopic lung surgeries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2024to 1 Aug 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status of I and II,
- Having body mass index (BMI) <35 kg/m2, pneumothorax, and bullae or lung nodules considered carcinoma in situ with a requirement for minimally invasive surgery and the patient will have single-port VATS.
Who cannot join
- Patient's refusal
- Age <18, pregnancy
- Spinal deformity or spinal surgical history
- Renal, hepatic patient,
- Allergies to local anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ultrasound-guided Erector Spine Plane Block Versus Single-injection Thoracic Paravertebral Block Via Intrathoracic Approach in Single-port Video-assisted Thoracoscopic Lung Surgeries in Postoperative Analgesia: a Randomized Controlled Trial.
Effect of ultrasound-guided erector spine plane block versus single-injection thoracic paravertebral block via intrathoracic approach in single-port video-assisted thoracoscopic lung surgeries in postoperative analgesia: a randomized controlled trial.
Read the detailed description
Traditional thoracotomy has great trauma and severe postoperative pain. At present, thoracoscopic minimally invasive surgery is the main method of thoracic surgery. Recently, single-port video-assisted thoracoscopic (SPVAT) surgery has been widely used in thoracic surgery, especially in lung wedge resection. SPVAT lung wedge resection has the advantages of less incision, less pain, and faster recovery. It was considered to have mild postoperative pain, and ignored the need for postoperative analgesia, resulting in insufficient analgesic measures after surgery. The postoperative pain is still severe, which seriously affects the patient's postoperative recovery Pain is more than just a physical process; it is a complex, subjective phenomenon. Pain can impair the hematologic, immune, hormonal, cardiac, and respiratory systems. Pain also can limit mobility, interfere with sleep and rest, and contribute to agitation, Psychosis, aggressive behavior, and delirium. Surgical centers need to pay attention to pain management because there appears to be a direct relationship between unrelieved pain and the cost of medical care, time spent in an intensive care unit, and length of hospital stay.
Inadequate analgesia causes respiratory, hemodynamic, endocrine, and metabolic complications. The preferred drugs for postoperative pain management are opioids. Usually, morphine is used for hemodynamic stability but it has a series of side effects like nausea, vomiting, constipation, and respiratory depression. NSAIDs are also used for analgesia. It also has some side effects such as gastrointestinal disturbance, renal impairment, decreased platelet function, and impaired coagulation.
Ultrasound guidance is rapidly becoming the gold standard for regional anesthesia. There is an ever-growing weight of evidence, matched with improving technology, to show that the use of ultrasound has significant benefits. The improved safety and efficacy that ultrasound brings to regional anesthesia will help promote its use and realize the benefits that regional anesthesia has, such as decreased morbidity and mortality, superior postoperative analgesia, cost-effectiveness, decreased postoperative complications, and an improved postoperative course. Although the risk of complications is minimized with the use of ultrasound, it requires advanced experience owing to its proximity to the pleura, epidural, and subarachnoid distance.
A simpler, quicker, effective, less invasive, and less complicated analgesic method can be used for postoperative analgesia after SPVAT lung wedge resection is to inject local anesthetics (LAs) directly into the paravertebral space via the intrathoracic approach under thoracoscopic direct vision to achieve the purpose of TPB under thoracoscopic direct vision, thereby reducing postoperative pain.
The erector spine plane block (ESPB) is a new technique that is easier to visualize and perform because it is more superficial. Owing to these advantages, it has been preferred frequently for postoperative analgesia in different types of operations such as thorax, abdomen, hip, and lumbar surgeries in recent years.
.
- Conditions
- Thoracoscopic Surgeries
- Being tested
- pain assessment after video assisted thoracoscopic lung surgeries
- Keywords
- thoracoscopic surgery, paravertebral block, erector spine block, ultrasound guided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain assessment after video assisted thoracoscopic lung surgeriesDiagnostic test
a scalp needle with an extended tube will be inserted into the paravertebral space at the T4 level under thoracoscopic direct vision before closing the chest. One centimeter adjacent to the vertebrae will be inserted vertically 0.5 cm under the parietal pleura with the needle, and 20 ml 0.25% bupivacaine will be injected then the field will be observed for 5 min to make sure that there is no hemorrhage or hematoma.
| Study group | Role | What they receive |
|---|---|---|
| Group (P) | Other | a scalp needle with an extended tube will be inserted into the paravertebral space at the T4 level under thoracoscopic direct vision before closing the chest. One centimeter adjacent to the vertebrae will be inserted vertically 0.5 cm under the parietal pleura with the needle, and 20 ml 0.25% bupivacaine will be injected then the field will be observed for 5 min to make sure that there is no hemorrhage or hematoma. Receives: Diagnostic Test: pain assessment after video assisted thoracoscopic lung surgeries |
| Group (E) | Other | the patient will be in the lateral position, by using US (Esaote MyLabSeven/ Esaote S.p.A, Genoa, Italy) a linear multifrequency 12 L probe and a 20-gauge 100 mm peripheral nerve block needle (Stimupleks Ultra 360 30°-BRA-04892510-01/B. Braun Melsungen AG, Hessen, Germany), the one-sided truncal block will be performed. The transverse process was visualized by placing the probe approximately 3 cm lateral to the spinous process of the T5 vertebrae for ESPB. When the needle advances in the craniocaudal direction with an angle of 30-40° and touched the transverse process, the presence of blood and/ or air will be checked by aspiration. Hydro-dissection was performed with 2-3 mL isotonic saline and 20 mL 0.25% bupivacaine (Marcaine 0.5%, 5 mg/mL) will be injected by observing that the erector spinae muscle (ESM) separates from the transverse process. Receives: Diagnostic Test: pain assessment after video assisted thoracoscopic lung surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative cumulative morphine consumption in the first 24 hours.
postoperative cumulative morphine consumption in the first 24 hours ing
Measured: 24 hours
Secondary outcomes (2)
1st postoperative rescue analgesic
1st dose of morphine in mg
Measured: discharge from OR to time to 1st dose of morphine
numerical rating scale
pain assessment after surgery using numerical rating scale
Measured: at the PACU, 2 hours, 4 hours, 6 hours, 18 hours, and at 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 posted7 Dec 2023
- Study start20 Feb 2024
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoscopic SurgeriesStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Gaber, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160375
- Sponsor's protocol ID
- pain control after VAT
- Acronym
- VAT
- Status last verified
- Mar 2024
- First submitted
- 29 Nov 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided Erector Spine Plane Block Versus Single-injection Thoracic Paravertebral Block Via Intrathoracic Approach in Single-port Video-assisted Thoracoscopic Lung Surgeries in Postoperative Analgesia: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06160375
- Acronym / sponsor ID
- VAT / pain control after VAT
- Conditions
- Thoracoscopic Surgeries
- Keywords
- thoracoscopic surgery, paravertebral block, erector spine block, ultrasound guided
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 7 Dec 2023 (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.
Effect of ultrasound-guided erector spine plane block versus single-injection thoracic paravertebral block via intrathoracic approach in single-port video-assisted thoracoscopic lung surgeries in postoperative analgesia: a randomized controlled trial.
Detailed description
Traditional thoracotomy has great trauma and severe postoperative pain. At present, thoracoscopic minimally invasive surgery is the main method of thoracic surgery. Recently, single-port video-assisted thoracoscopic (SPVAT) surgery has been widely used in thoracic surgery, especially in lung wedge resection. SPVAT lung wedge resection has the advantages of less incision, less pain, and faster recovery. It was considered to have mild postoperative pain, and ignored the need for postoperative analgesia, resulting in insufficient analgesic measures after surgery. The postoperative pain is still severe, which seriously affects the patient's postoperative recovery Pain is more than just a physical process; it is a complex, subjective phenomenon. Pain can impair the hematologic, immune, hormonal, cardiac, and respiratory systems. Pain also can limit mobility, interfere with sleep and rest, and contribute to agitation, Psychosis, aggressive behavior, and delirium. Surgical centers need to pay attention to pain management because there appears to be a direct relationship between unrelieved pain and the cost of medical care, time spent in an intensive care unit, and length of hospital stay.
Inadequate analgesia causes respiratory, hemodynamic, endocrine, and metabolic complications. The preferred drugs for postoperative pain management are opioids. Usually, morphine is used for hemodynamic stability but it has a series of side effects like nausea, vomiting, constipation, and respiratory depression. NSAIDs are also used for analgesia. It also has some side effects such as gastrointestinal disturbance, renal impairment, decreased platelet function, and impaired coagulation.
Ultrasound guidance is rapidly becoming the gold standard for regional anesthesia. There is an ever-growing weight of evidence, matched with improving technology, to show that the use of ultrasound has significant benefits. The improved safety and efficacy that ultrasound brings to regional anesthesia will help promote its use and realize the benefits that regional anesthesia has, such as decreased morbidity and mortality, superior postoperative analgesia, cost-effectiveness, decreased postoperative complications, and an improved postoperative course. Although the risk of complications is minimized with the use of ultrasound, it requires advanced experience owing to its proximity to the pleura, epidural, and subarachnoid distance.
A simpler, quicker, effective, less invasive, and less complicated analgesic method can be used for postoperative analgesia after SPVAT lung wedge resection is to inject local anesthetics (LAs) directly into the paravertebral space via the intrathoracic approach under thoracoscopic direct vision to achieve the purpose of TPB under thoracoscopic direct vision, thereby reducing postoperative pain.
The erector spine plane block (ESPB) is a new technique that is easier to visualize and perform because it is more superficial. Owing to these advantages, it has been preferred frequently for postoperative analgesia in different types of operations such as thorax, abdomen, hip, and lumbar surgeries in recent years.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (P) | Other | Diagnostic Test: pain assessment after video assisted thoracoscopic lung surgeriesa scalp needle with an extended tube will be inserted into the paravertebral space at the T4 level under thoracoscopic direct vision before closing the chest. One centimeter adjacent to the vertebrae will be inserted vertically 0.5 cm under the parietal pleura with the needle, and 20 ml 0.25% bupivacaine will be injected then the field will be observed for 5 min to make sure that there is no hemorrhage or hematoma. |
| Group (E) | Other | Diagnostic Test: pain assessment after video assisted thoracoscopic lung surgeriesthe patient will be in the lateral position, by using US (Esaote MyLabSeven/ Esaote S.p.A, Genoa, Italy) a linear multifrequency 12 L probe and a 20-gauge 100 mm peripheral nerve block needle (Stimupleks Ultra 360 30°-BRA-04892510-01/B. Braun Melsungen AG, Hessen, Germany), the one-sided truncal block will be performed. The transverse process was visualized by placing the probe approximately 3 cm lateral to the spinous process of the T5 vertebrae for ESPB. When the needle advances in the craniocaudal direction with an angle of 30-40° and touched the transverse process, the presence of blood and/ or air will be checked by aspiration. Hydro-dissection was performed with 2-3 mL isotonic saline and 20 mL 0.25% bupivacaine (Marcaine 0.5%, 5 mg/mL) will be injected by observing that the erector spinae muscle (ESM) separates from the transverse process. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status of I and II,
- Having body mass index (BMI) <35 kg/m2, pneumothorax, and bullae or lung nodules considered carcinoma in situ with a requirement for minimally invasive surgery and the patient will have single-port VATS.
Key exclusion criteria (5 listed)
- Patient's refusal
- Age <18, pregnancy
- Spinal deformity or spinal surgical history
- Renal, hepatic patient,
- Allergies to local anesthetics.
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 |
|---|---|---|
| pain assessment after video assisted thoracoscopic lung surgeriesa scalp needle with an extended tube will be inserted into the paravertebral space at the T4 level under thoracoscopic direct vision before closing the chest. One centimeter adjacent to the vertebrae will be inserted vertically 0.5 cm under the parietal pleura with the needle, and 20 ml 0.25% bupivacaine will be injected then the field will be observed for 5 min to make sure that there is no hemorrhage or hematoma. | Diagnostic test | Group (E), Group (P) |
Primary outcome
postoperative cumulative morphine consumption in the first 24 hours.
Time frame: 24 hours
postoperative cumulative morphine consumption in the first 24 hours ing
2 secondary outcomes
1st postoperative rescue analgesic
Time frame: discharge from OR to time to 1st dose of morphine
numerical rating scale
Time frame: at the PACU, 2 hours, 4 hours, 6 hours, 18 hours, and at 24 hours post operative
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 5 Sep 2024.
- 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. 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 pain assessment after video assisted thoracoscopic lung surgeries in people with Thoracoscopic Surgeries, run by Ain Shams 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 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 5 Sep 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?
postoperative cumulative morphine consumption in the first 24 hours. (time frame: 24 hours). 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 5 Sep 2024.