Back to resultsRhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy
Primary Purpose
Esophagus Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Catheterization
Single nerve block
Continuous nerve block
PCIA
Sponsored by
About this trial
This is an interventional treatment trial for Esophagus Cancer focused on measuring Rhomboid intercostal and subserratum plane block, Ultrasound-guided, Postoperative analgesia, Minimally invasive esophagectomy
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.
Sites / Locations
- FulingCHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
continuous RISS group
single RISS group
PCIA group
Arm Description
Patients were given continuous RISS plane block in addition to patient controlled intravenous analgesia.
Patients were given single RISS plane block in addition to patient controlled intravenous analgesia.
Patients were given patient controlled intravenous analgesia.
Outcomes
Primary Outcome Measures
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)
mean arterial pressure (MAP)
The mean arterial pressure (MAP)on the monitor at different times was recorded.
Heart rate (HR)
The Heart rate (HR)on the monitor at different times was recorded.
Secondary Outcome Measures
dizziness
The occurrence of dizziness was recorded
lethargy
The occurrence of lethargy was recorded
nausea or vomiting
The occurrence of nausea /vomiting was recorded
hypotension
The occurrence of hypotension was recorded
respiratory depression
The occurrence of respiratory depression was recorded
urinary retention
The occurrence of urinary retention was recorded
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06092944
Brief Title
Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy
Official Title
Clinical Study of Rhomboid Intercostal and Subserratum Plane Block for Postoperative Analgesia in Minimally Invasive Esophagectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luo Fuchao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer
Keywords
Rhomboid intercostal and subserratum plane block, Ultrasound-guided, Postoperative analgesia, Minimally invasive esophagectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
continuous RISS group
Arm Type
Experimental
Arm Description
Patients were given continuous RISS plane block in addition to patient controlled intravenous analgesia.
Arm Title
single RISS group
Arm Type
Experimental
Arm Description
Patients were given single RISS plane block in addition to patient controlled intravenous analgesia.
Arm Title
PCIA group
Arm Type
Active Comparator
Arm Description
Patients were given patient controlled intravenous analgesia.
Intervention Type
Procedure
Intervention Name(s)
Catheterization
Intervention 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。
Intervention Type
Procedure
Intervention Name(s)
Single nerve block
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Continuous nerve block
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
PCIA
Intervention 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
Primary Outcome Measure Information:
Title
Analgesic effect
Description
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)
Time Frame
2, 6, 12, 24, and 48 hours after surgery
Title
mean arterial pressure (MAP)
Description
The mean arterial pressure (MAP)on the monitor at different times was recorded.
Time Frame
before anesthesia induction (T0)， before skin incision（T1）， 5 minutes after skin incision
Title
Heart rate (HR)
Description
The Heart rate (HR)on the monitor at different times was recorded.
Time Frame
before anesthesia induction (T0)， before skin incision（T1）， 5 minutes after skin incision
Secondary Outcome Measure Information:
Title
dizziness
Description
The occurrence of dizziness was recorded
Time Frame
24hours after surgery
Title
lethargy
Description
The occurrence of lethargy was recorded
Time Frame
24hours after surgery
Title
nausea or vomiting
Description
The occurrence of nausea /vomiting was recorded
Time Frame
24hours after surgery
Title
hypotension
Description
The occurrence of hypotension was recorded
Time Frame
24hours after surgery
Title
respiratory depression
Description
The occurrence of respiratory depression was recorded
Time Frame
24hours after surgery
Title
urinary retention
Description
The occurrence of urinary retention was recorded
Time Frame
24hours after surgery
Title
Analgesia satisfaction
Description
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.
Time Frame
24hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luo fuchao, MD
Phone
+8613896658090
Email
luokyyx@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luo fuchao, MD
Organizational Affiliation
Chongqing University Fuling Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
FulingCH
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luo fuchao, MD
Phone
+86 13896658090
Email
luokyyx@163.com
First Name & Middle Initial & Last Name & Degree
Luo fuchao, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy
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