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Trial Title:
Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy
NCT ID:
NCT06092944
Condition:
Esophagus Cancer
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
Rhomboid intercostal and subserratum plane block
Ultrasound-guided
Postoperative analgesia
Minimally invasive esophagectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Catheterization
Description:
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。
Arm group label:
continuous RISS group
Intervention type:
Procedure
Intervention name:
Single nerve block
Description:
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.
Arm group label:
continuous RISS group
Arm group label:
single RISS group
Intervention type:
Procedure
Intervention name:
Continuous nerve block
Description:
After surgery,local anesthetics were injected continuously through catheters.Local
anesthetic formula:Ropivacaine 300mg + normal saline, prepared into 150milliliters
liquid, background dose 2milliliters/h.
Arm group label:
continuous RISS group
Intervention type:
Procedure
Intervention name:
PCIA
Description:
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
Arm group label:
PCIA group
Arm group label:
continuous RISS group
Arm group label:
single RISS group
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).
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
FulingCH
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Luo fuchao, MD
Phone:
+86 13896658090
Email:
luokyyx@163.com
Investigator:
Last name:
Luo fuchao, MD
Email:
Principal Investigator
Start date:
March 1, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Luo Fuchao
Agency class:
Other
Source:
Fuling Central Hospital of Chongqing City
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06092944
