Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study of Rhomboid Intercostal and Subserratum Plane Block for Postoperative Analgesia in Minimally Invasive Esophagectomy

Conditions
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Esophagus Cancer

Intervention / Treatment
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* Procedure: Catheterization
* Procedure: Single nerve block
* Procedure: Continuous nerve block
* Procedure: PCIA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: continuous RISS group<br>Patients were given continuous RISS plane block in addition to patient controlled intravenous analgesia. | Procedure: Catheterization<br>* 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。<br>Procedure: Single nerve block<br>* 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.<br>Procedure: Continuous nerve block<br>* After surgery,local anesthetics were injected continuously through catheters.Local anesthetic formula:Ropivacaine 300mg + normal saline, prepared into 150milliliters liquid, background dose 2milliliters/h.<br>Procedure: PCIA<br>* 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<br>|
| Experimental: single RISS group<br>Patients were given single RISS plane block in addition to patient controlled intravenous analgesia. | Procedure: Single nerve block<br>* 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.<br>Procedure: PCIA<br>* 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<br>|
| Active Comparator: PCIA group<br>Patients were given patient controlled intravenous analgesia. | Procedure: PCIA<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhomboid intercostal and subserratum plane block, Ultrasound-guided, Postoperative analgesia, Minimally invasive esophagectomy