Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy

October 16, 2023 updated by: Luo Fuchao

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • FulingCH
        • Contact:
        • Principal Investigator:
          • Luo fuchao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: continuous RISS group
Patients were given continuous RISS plane block in addition to patient controlled intravenous analgesia.
Procedure: Catheterization
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。
Procedure: Single nerve block
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.
Procedure: Continuous nerve block
After surgery,local anesthetics were injected continuously through catheters.Local anesthetic formula:Ropivacaine 300mg + normal saline, prepared into 150milliliters liquid, background dose 2milliliters/h.
Procedure: PCIA
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
Experimental: single RISS group
Patients were given single RISS plane block in addition to patient controlled intravenous analgesia.
Procedure: Single nerve block
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.
Procedure: PCIA
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
Active Comparator: PCIA group
Patients were given patient controlled intravenous analgesia.
Procedure: PCIA
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
2, 6, 12, 24, and 48 hours after surgery
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.
before anesthesia induction (T0)， before skin incision（T1）， 5 minutes after skin incision
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.
before anesthesia induction (T0)， before skin incision（T1）， 5 minutes after skin incision

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
dizziness
Time Frame: 24hours after surgery
The occurrence of dizziness was recorded
24hours after surgery
lethargy
Time Frame: 24hours after surgery
The occurrence of lethargy was recorded
24hours after surgery
nausea or vomiting
Time Frame: 24hours after surgery
The occurrence of nausea /vomiting was recorded
24hours after surgery
hypotension
Time Frame: 24hours after surgery
The occurrence of hypotension was recorded
24hours after surgery
respiratory depression
Time Frame: 24hours after surgery
The occurrence of respiratory depression was recorded
24hours after surgery
urinary retention
Time Frame: 24hours after surgery
The occurrence of urinary retention was recorded
24hours after surgery
Analgesia satisfaction
Time Frame: 24hours after surgery
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.
24hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Luo Fuchao

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luo fuchao, MD, Chongqing University Fuling Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RISS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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