Thoracic SympathectomyNCT04486014
Analgesic Effect of Erector Spinae Versus Serratus Anterior Plane Block for Thoracoscopic Sympathectomy
A study testing Erector spinae plane block and Serratus anterior plane block in people with Thoracic Sympathectomy, run by Mansoura University at 1 site in Egypt.
Trial summary
Thoracic incisions are painful and associated with chronic post-surgical pain and inadequate analgesia is associated with poorer postoperative outcomes. Recent progress has been made in the field of thoracic anesthesia by improving analgesic modalities such as PECS 1 and PECS 2, intercostal plane block, paravertebral… Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Thoracic Sympathectomy
- What is being tested?
- Erector spinae plane block and Serratus anterior plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Sep 2020to Jan 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 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists grade I or II physical status
Who cannot join
- Patients who had coagulopathies
- local infections
- neuropathies
- neuromuscular disease
- psychiatric disease
- history of thoracic surgery
Show all 9Show fewer
- history of allergy to local anesthetics.
- receiving chronic analgesic therapy
- drug abusers
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah, DK, 050
Mohamed Y Makharita, MD, 00201284122800, m_younis24@yahoo.com
Doaa G Diab, MD, 00201069507088, basmalg@yahoo.com
About this study
Official title: A Comparative Study of the Analgesic Effect of Ultrasound-guided Erector Spinae Plane Block Versus Serratus Anterior Plane Block for Thoracoscopic Sympathectomy Surgeries
- Thoracic incisions are painful and associated with chronic post-surgical pain and inadequate analgesia is associated with poorer postoperative outcomes. Recent progress has been made in the field of thoracic anesthesia by improving analgesic modalities such as PECS 1 and PECS 2, intercostal plane block, paravertebral regional anesthesia, ultrasound-guided erector spinae and serratus anterior plane block.
- Administered of the local anesthetic in erector spinae plane block is in the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces. It affects both the ventral and dorsal rami and leading to blockage of both visceral and somatic pain.
- Ultrasound-guided serratus anterior plane block is a facial plane block that provides analgesia by blocking of lateral branches of intercostal nerves above or below the serratus plane muscle.
- We hypothesize that the ultrasound-guided erector spinae plane block may have better quality than the serratus anterior plane block for patients undergoing thoracoscopic sympathectomy as erector spinea plane blocks visceral and somatic pain.
Read the detailed description
Primary palmar hyperhidrosis (PPH) refers to the excessive secretion of exocrine glands on the palms, which is often accompanied by the head, face, or plantar hyperhidrosis. PPH demonstrates no obvious organic cause; however, some patients may feel distressed because their palms sweat more than normal, and such a situation may lead to severe psychological, social, and occupational dysfunction.
Endoscopic thoracic sympathectomy abolishes eccrine sweating in all areas supplied by the postganglionic fibers with its complications which include post-sympathetic neuralgia which is the most important, wound infection, hemorrhage, pneumothorax, horner syndrome, no response to the operation and compensatory hyperhidrosis in non-denervated areas.
Forero described ultrasound-guided erector spinae plane block for treatment of thoracic neuropathic pain and explained it as a peri-paravertebral regional anesthesia technique that has been used for prevention of postoperative pain in various surgeries.
Ultrasound-guided serratus anterior plane block is a facial plane block which provides analgesia by blocking of lateral branches of intercostal nerves above or below the serratus plane muscle. There are few cases and studies in the literature reporting successful analgesia provided by serratus anterior plane block
- Conditions
- Thoracic Sympathectomy
- Being tested
- 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.
Erector spinae plane blockProcedure or surgery
Erector Spinae Group (Group E) will receive bilateral ultrasound-guided erector spinae plane block using 30 ml hyperbaric bupivacaine 0.25% will be injected between erector spinae muscle and transverse process of T4
Serratus anterior plane blockProcedure or surgery
Serratus anterior Group (Group S) will undergo bilateral ultrasound-guided serratus anterior plane block with 30 ml hyperbaric bupivacaine 0.25% will be injected above or below serratus anterior muscle at the level of 4th and 5th rib on the midaxillary line
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block (ESP) | Experimental | Patients would receive erector spinae plane block Receives: Procedure: Erector spinae plane block |
| Serratus anterior plane block (SAP) | Experimental | Patients would receive serratus anterior plane block Receives: Procedure: Serratus anterior plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total analgesic consumption
cumulative consumption of opioids during the first postoperative day
Measured: 1st 24 hours after surgery
Secondary outcomes (13)
Postoperative severity of the pain
Visual analogue scale (0-100),where 0 point is equal to no pain and 100 indicate the worst possible pain
Measured: every 2 hours for 12hours and then at 16, 20 and 24 hours postoperatively
The total amount of fentanyl consumption
cumulative consumption of fentanyl during the first postoperative day
Measured: 1st 24 hours after surgery
The total amount of paracetamol consumption
cumulative consumption of paracetamol during the first post operative day
Measured: 1st 24 hours after surgery
Duration of analgesia
from the end of block till the time for the first analgesic requirement (ketorolac)
Measured: within 24 hours after surgery
Nausea
number of patients with nausea
Measured: 1st 24 hours after surgery
Vomiting
number of patients with vomiting
Measured: 1st 24 hours after surgery
Patient Satisfaction
evaluated as 5:excellent, 4:very good, 3:good, 2: fair, 1:poor
Measured: After 12 and 24 hours after surgery
Heart rate
changes in heart rate
Measured: Intraoperative (every 10 minutes till the end of surgery)
Peripheral oxygen saturation
changes in Peripheral oxygen saturation as measured with pulse oximetry
Measured: Intraoperative (every 10 minutes till the end of surgery)
End-tidal carbon dioxide tension
changes in end-tidal carbon dioxide tension as measured with capnography
Measured: Intraoperative (every 10 minutes till the end of surgery)
systolic blood pressure
changes in systolic blood pressure
Measured: Intraoperative (every 10 minutes till the end of surgery)
diastolic blood pressures
changes in diastolic blood pressure
Measured: Intraoperative (every 10 minutes till the end of surgery)
mean blood pressures
changes in mean arterial blood pressure
Measured: Intraoperative (every 10 minutes till the end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start14 Sep 2020
- Primary completionJul 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SympathectomyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Y Makharita, MD, Study chair, Professor of Anesthesia and Surgical Intensive care,PDoaa G Diab, MD, Study director, Associate Professor of Anesthesia and Surgical Intensive care,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486014
- Sponsor's protocol ID
- MD.20.04.307
- Status last verified
- Sep 2020
- First submitted
- 22 Jul 2020
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Analgesic Effect of Ultrasound-guided Erector Spinae Plane Block Versus Serratus Anterior Plane Block for Thoracoscopic Sympathectomy Surgeries
- ClinicalTrials.gov ID
- NCT04486014
- Acronym / sponsor ID
- MD.20.04.307
- Conditions
- Thoracic Sympathectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 24 Jul 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.
- Thoracic incisions are painful and associated with chronic post-surgical pain and inadequate analgesia is associated with poorer postoperative outcomes. Recent progress has been made in the field of thoracic anesthesia by improving analgesic modalities such as PECS 1 and PECS 2, intercostal plane block, paravertebral regional anesthesia, ultrasound-guided erector spinae and serratus anterior plane block.
- Administered of the local anesthetic in erector spinae plane block is in the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces. It affects both the ventral and dorsal rami and leading to blockage of both visceral and somatic pain.
- Ultrasound-guided serratus anterior plane block is a facial plane block that provides analgesia by blocking of lateral branches of intercostal nerves above or below the serratus plane muscle.
- We hypothesize that the ultrasound-guided erector spinae plane block may have better quality than the serratus anterior plane block for patients undergoing thoracoscopic sympathectomy as erector spinea plane blocks visceral and somatic pain.
Detailed description
Primary palmar hyperhidrosis (PPH) refers to the excessive secretion of exocrine glands on the palms, which is often accompanied by the head, face, or plantar hyperhidrosis. PPH demonstrates no obvious organic cause; however, some patients may feel distressed because their palms sweat more than normal, and such a situation may lead to severe psychological, social, and occupational dysfunction.
Endoscopic thoracic sympathectomy abolishes eccrine sweating in all areas supplied by the postganglionic fibers with its complications which include post-sympathetic neuralgia which is the most important, wound infection, hemorrhage, pneumothorax, horner syndrome, no response to the operation and compensatory hyperhidrosis in non-denervated areas.
Forero described ultrasound-guided erector spinae plane block for treatment of thoracic neuropathic pain and explained it as a peri-paravertebral regional anesthesia technique that has been used for prevention of postoperative pain in various surgeries.
Ultrasound-guided serratus anterior plane block is a facial plane block which provides analgesia by blocking of lateral branches of intercostal nerves above or below the serratus plane muscle. There are few cases and studies in the literature reporting successful analgesia provided by serratus anterior plane block
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block (ESP) | Experimental | Procedure: Erector spinae plane blockPatients would receive erector spinae plane block |
| Serratus anterior plane block (SAP) | Experimental | Procedure: Serratus anterior plane blockPatients would receive serratus anterior plane block |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists grade I or II physical status
Key exclusion criteria (9 listed)
- Patients who had coagulopathies
- local infections
- neuropathies
- neuromuscular disease
- psychiatric disease
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 |
|---|---|---|
| Erector spinae plane blockErector Spinae Group (Group E) will receive bilateral ultrasound-guided erector spinae plane block using 30 ml hyperbaric bupivacaine 0.25% will be injected between erector spinae muscle and transverse process of T4 | Procedure or surgery | Erector spinae plane block (ESP) |
| Serratus anterior plane blockSerratus anterior Group (Group S) will undergo bilateral ultrasound-guided serratus anterior plane block with 30 ml hyperbaric bupivacaine 0.25% will be injected above or below serratus anterior muscle at the level of 4th and 5th rib on the midaxillary line | Procedure or surgery | Serratus anterior plane block (SAP) |
Primary outcome
The total analgesic consumption
Time frame: 1st 24 hours after surgery
cumulative consumption of opioids during the first postoperative day
13 secondary outcomes
Postoperative severity of the pain
Time frame: every 2 hours for 12hours and then at 16, 20 and 24 hours postoperatively
The total amount of fentanyl consumption
Time frame: 1st 24 hours after surgery
The total amount of paracetamol consumption
Time frame: 1st 24 hours after surgery
Duration of analgesia
Time frame: within 24 hours after surgery
Nausea
Time frame: 1st 24 hours after surgery
Vomiting
Time frame: 1st 24 hours after surgery
Patient Satisfaction
Time frame: After 12 and 24 hours after surgery
Heart rate
Time frame: Intraoperative (every 10 minutes till the end of surgery)
Peripheral oxygen saturation
Time frame: Intraoperative (every 10 minutes till the end of surgery)
End-tidal carbon dioxide tension
Time frame: Intraoperative (every 10 minutes till the end of surgery)
systolic blood pressure
Time frame: Intraoperative (every 10 minutes till the end of surgery)
diastolic blood pressures
Time frame: Intraoperative (every 10 minutes till the end of surgery)
mean blood pressures
Time frame: Intraoperative (every 10 minutes till the end of surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
Related trials for Thoracic Sympathectomy
Not yet recruitingObservational study
Clinical Value of Routine Chest Radiography and Point-of-Care Lung Ultrasound Following Ambulatory Thoracic Sympathectomy
Pneumothorax Iatrogenic Postprocedural
RecruitingObservational study
POLish Registry of CArdioneuroablation and CArdioneuromodulation
Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS
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.
Mohamed Y Makharita, MD study chair
Professor of Anesthesia and Surgical Intensive care,P
Doaa G Diab, MD study director
Associate Professor of Anesthesia and Surgical Intensive care,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block and Serratus anterior plane block in people with Thoracic Sympathectomy, run by Mansoura 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 1 inclusion and 9 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 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Y Makharita, MD (00201284122800, m_younis24@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total analgesic consumption (time frame: 1st 24 hours after surgery). 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 Feb 2021.