Esophagus CancerNCT06092944
Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy
A study testing Catheterization, Single nerve block and Continuous nerve block in people with Esophagus Cancer, run by Luo Fuchao at 1 site in China.
Trial summary
The objective is to investigate the safety and effectiveness of rhomboid intercostal and subserratum plane (RISS) block for postoperative analgesia after minimally invasive McKeown esophagectomy (MIE-McKeown). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- Catheterization, Single nerve block and Continuous nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients received MIE-McKeown surgery and were confirmed by postoperative pathology; Age 18-75 years old
- body mass index (BMI) : 18.5~23.9kg/m2;
- American Society of Anesthesiologists (ASA) grade: Ⅰ~Ⅱ;
- Clear consciousness, no cognitive impairment;
- Patients informed to participate in the study and signed informed consent.
Who cannot join
- Infection of the puncture site, abnormal platelet or coagulation function;
- Patients with drug allergy involved in this study;
- Long-term use of analgesic, sedative drugs or a history of heavy drinking;
- Patients with chronic painful diseases;
- With severe heart, liver, kidney and lung dysfunction;
- Infectious diseases, blood, immune, circulatory system diseases; -Communication barriers, can not cooperate with the scale assessment; -
- Other situations not suitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
FulingCH
Chongqing
Luo fuchao, MD, +86 13896658090, luokyyx@163.com
Luo fuchao, MD
About this study
Official title: Clinical Study of Rhomboid Intercostal and Subserratum Plane Block for Postoperative Analgesia in Minimally Invasive Esophagectomy
The objective is to investigate the safety and effectiveness of rhomboid intercostal and subserratum plane (RISS) block for postoperative analgesia after minimally invasive McKeown esophagectomy (MIE-McKeown).
Read the detailed description
Rhomboid intercostal and subserratum plane block (RISS) is a nerve block technique in which local anesthetics are injected into the rhomboid-intercostal muscle planes and the serratus anterius-intercostal muscle planes, and the intercostal nerve is blocked by diffusion of local anesthetics. It is confirmed that RISS can provide analgesia not only in the front half of the chest, but also in the upper abdomen. However, the efficacy of RISS in minimally invasive surgery for esophageal cancer has not been proven. The investigators placed catheters on the RISS plane and continuously injected local anesthetics to investigate whether RISS is effective and safe in minimally invasive esophageal cancer surgery.
- Conditions
- Esophagus Cancer
- Being tested
- Catheterization, Single nerve block, Continuous nerve block, PCIA
- Keywords
- Rhomboid intercostal and subserratum plane block, Ultrasound-guided, Postoperative analgesia, Minimally invasive esophagectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CatheterizationProcedure or surgery
Before the operation,the patient was placed in the left lateral position.The catheter（soft tip epidural catheter 20-gauge-100 cm） was placed at the rhomboid-intercostal plane under ultrasound guidance at the T5-T6 level, followed by ultrasound-guided catheter placed in the anterior serrated muscle plane at the T7-9 level。
Single nerve blockProcedure or surgery
Before the operation,40milliliters of 0.3% ropivacaine was injected into the rhomboid-intercostal fascia plane and anterior serrated muscle plane respectively under the guidance of ultrasound.
Continuous nerve blockProcedure or surgery
After surgery,local anesthetics were injected continuously through catheters.Local anesthetic formula:Ropivacaine 300mg + normal saline, prepared into 150milliliters liquid, background dose 2milliliters/h.
PCIAProcedure or surgery
After surgery, the patient was given controlled intravenous analgesia. Analgesic pump drug formula:Sufentanil 50ug+ Dezocine 20mg+ Granisetron 10mg+150milliliters saline, continuous dose of 2milliliters/h intravenous pump, single injection dose of 2milliliters, locking time of 20 min
| Study group | Role | What they receive |
|---|---|---|
| continuous RISS group | Experimental | Patients were given continuous RISS plane block in addition to patient controlled intravenous analgesia. Receives: Procedure: Catheterization; Procedure: Single nerve block; Procedure: Continuous nerve block; Procedure: PCIA |
| single RISS group | Experimental | Patients were given single RISS plane block in addition to patient controlled intravenous analgesia. Receives: Procedure: Single nerve block; Procedure: PCIA |
| PCIA group | Active comparator | Patients were given patient controlled intravenous analgesia. Receives: Procedure: PCIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic effect
patient will be asked to rate their pain level at rest and cough respectively using visual analogue scale（VAS）.(0 being no pain, 10 being worst pain imaginable)
Measured: 2, 6, 12, 24, and 48 hours after surgery
mean arterial pressure (MAP)
The mean arterial pressure (MAP)on the monitor at different times was recorded.
Measured: before anesthesia induction (T0)， before skin incision（T1）， 5 minutes after skin incision
Heart rate (HR)
The Heart rate (HR)on the monitor at different times was recorded.
Measured: before anesthesia induction (T0)， before skin incision（T1）， 5 minutes after skin incision
Secondary outcomes (7)
dizziness
The occurrence of dizziness was recorded
Measured: 24hours after surgery
lethargy
The occurrence of lethargy was recorded
Measured: 24hours after surgery
nausea or vomiting
The occurrence of nausea /vomiting was recorded
Measured: 24hours after surgery
hypotension
The occurrence of hypotension was recorded
Measured: 24hours after surgery
respiratory depression
The occurrence of respiratory depression was recorded
Measured: 24hours after surgery
urinary retention
The occurrence of urinary retention was recorded
Measured: 24hours after surgery
Analgesia satisfaction
patient will be asked to rate their Satisfaction with analgesia using verbal rating scales (VRS) .Scores from 1 to 5 represent very dissatisfied, not satisfied, basically satisfied, relatively satisfied, and very satisfied with the analgesic effect, respectively.
Measured: 24hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Mar 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies 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
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luo Fuchao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luo Fuchao, Fuling Central Hospital of Chongqing City
- Investigators
- Luo fuchao, MD, Principal investigator, Chongqing University Fuling Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092944
- Sponsor's protocol ID
- RISS
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Rhomboid Intercostal and Subserratum Plane Block for Postoperative Analgesia in Minimally Invasive Esophagectomy
- ClinicalTrials.gov ID
- NCT06092944
- Acronym / sponsor ID
- RISS
- Conditions
- Esophagus Cancer
- Keywords
- Rhomboid intercostal and subserratum plane block, Ultrasound-guided, Postoperative analgesia, Minimally invasive esophagectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Luo FuchaoUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 23 Oct 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.
The objective is to investigate the safety and effectiveness of rhomboid intercostal and subserratum plane (RISS) block for postoperative analgesia after minimally invasive McKeown esophagectomy (MIE-McKeown).
Detailed description
Rhomboid intercostal and subserratum plane block (RISS) is a nerve block technique in which local anesthetics are injected into the rhomboid-intercostal muscle planes and the serratus anterius-intercostal muscle planes, and the intercostal nerve is blocked by diffusion of local anesthetics. It is confirmed that RISS can provide analgesia not only in the front half of the chest, but also in the upper abdomen. However, the efficacy of RISS in minimally invasive surgery for esophageal cancer has not been proven. The investigators placed catheters on the RISS plane and continuously injected local anesthetics to investigate whether RISS is effective and safe in minimally invasive esophageal cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| continuous RISS group | Experimental | Procedure: Catheterization, Procedure: Single nerve block, Procedure: Continuous nerve block, Procedure: PCIAPatients were given continuous RISS plane block in addition to patient controlled intravenous analgesia. |
| single RISS group | Experimental | Procedure: Single nerve block, Procedure: PCIAPatients were given single RISS plane block in addition to patient controlled intravenous analgesia. |
| PCIA group | Active comparator | Procedure: PCIAPatients were given patient controlled intravenous analgesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients received MIE-McKeown surgery and were confirmed by postoperative pathology; Age 18-75 years old
- body mass index (BMI) : 18.5~23.9kg/m2;
- American Society of Anesthesiologists (ASA) grade: Ⅰ~Ⅱ;
- Clear consciousness, no cognitive impairment;
- Patients informed to participate in the study and signed informed consent.
Key exclusion criteria (7 listed)
- Infection of the puncture site, abnormal platelet or coagulation function;
- Patients with drug allergy involved in this study;
- Long-term use of analgesic, sedative drugs or a history of heavy drinking;
- Patients with chronic painful diseases;
- With severe heart, liver, kidney and lung dysfunction;
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 |
|---|---|---|
| CatheterizationBefore the operation,the patient was placed in the left lateral position.The catheter（soft tip epidural catheter 20-gauge-100 cm） was placed at the rhomboid-intercostal plane under ultrasound guidance at the T5-T6 level, followed by ultrasound-guided catheter placed in the anterior serrated muscle plane at the T7-9 level。 | Procedure or surgery | continuous RISS group |
| Single nerve blockBefore the operation,40milliliters of 0.3% ropivacaine was injected into the rhomboid-intercostal fascia plane and anterior serrated muscle plane respectively under the guidance of ultrasound. | Procedure or surgery | continuous RISS group, single RISS group |
| Continuous nerve blockAfter surgery,local anesthetics were injected continuously through catheters.Local anesthetic formula:Ropivacaine 300mg + normal saline, prepared into 150milliliters liquid, background dose 2milliliters/h. | Procedure or surgery | continuous RISS group |
| PCIAAfter surgery, the patient was given controlled intravenous analgesia. Analgesic pump drug formula:Sufentanil 50ug+ Dezocine 20mg+ Granisetron 10mg+150milliliters saline, continuous dose of 2milliliters/h intravenous pump, single injection dose of 2milliliters, locking time of 20 min | Procedure or surgery | PCIA group, continuous RISS group, single RISS group |
Primary outcome
Analgesic effect
Time frame: 2, 6, 12, 24, and 48 hours after surgery
patient will be asked to rate their pain level at rest and cough respectively using visual analogue scale（VAS）.(0 being no pain, 10 being worst pain imaginable)
mean arterial pressure (MAP)
Time frame: before anesthesia induction (T0)， before skin incision（T1）， 5 minutes after skin incision
The mean arterial pressure (MAP)on the monitor at different times was recorded.
Heart rate (HR)
Time frame: before anesthesia induction (T0)， before skin incision（T1）， 5 minutes after skin incision
The Heart rate (HR)on the monitor at different times was recorded.
7 secondary outcomes
dizziness
Time frame: 24hours after surgery
lethargy
Time frame: 24hours after surgery
nausea or vomiting
Time frame: 24hours after surgery
hypotension
Time frame: 24hours after surgery
respiratory depression
Time frame: 24hours after surgery
urinary retention
Time frame: 24hours after surgery
Analgesia satisfaction
Time frame: 24hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Luo fuchao, MD principal investigator
Chongqing University Fuling Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheterization, Single nerve block and Continuous nerve block in people with Esophagus Cancer, run by Luo Fuchao at 1 site in China.
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 5 inclusion and 7 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 23 Oct 2023. 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 China. 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 Luo fuchao, MD (+8613896658090, luokyyx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic effect (time frame: 2, 6, 12, 24, and 48 hours after surgery). The study lists 3 primary outcomes in all. 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 23 Oct 2023.