Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy

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: Recruiting
• Conditions: Esophagus Cancer
• Intervention / Treatment: Procedure: Catheterization; Procedure: Single nerve block; Procedure: Continuous nerve block; Procedure: PCIA

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: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luo fuchao, MD; Phone Number: +8613896658090; Email: luokyyx@163.com

Study Locations

• China
  • Chongqing, China
    • Recruiting
    • FulingCH
    • Contact: Luo fuchao, MD; Phone Number: +86 13896658090; Email: luokyyx@163.com
    • Principal Investigator: Luo fuchao, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)	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.	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.	before anesthesia induction (T0)， before skin incision（T1）， 5 minutes after skin incision

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dizziness	The occurrence of dizziness was recorded	24hours after surgery
lethargy	The occurrence of lethargy was recorded	24hours after surgery
nausea or vomiting	The occurrence of nausea /vomiting was recorded	24hours after surgery
hypotension	The occurrence of hypotension was recorded	24hours after surgery
respiratory depression	The occurrence of respiratory depression was recorded	24hours after surgery
urinary retention	The occurrence of urinary retention was recorded	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.	24hours after surgery

Collaborators and Investigators

• Sponsor: Luo Fuchao
• Investigators: Principal Investigator: Luo fuchao, MD, Chongqing University Fuling Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound-guided; Postoperative analgesia; Minimally invasive esophagectomy; Rhomboid intercostal and subserratum plane block
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID 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