Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy

NCT ID: NCT06092944

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-12-30

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.

Conditions

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Esophagus Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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continuous RISS group

Patients were given continuous RISS plane block in addition to patient controlled intravenous analgesia.

Group Type EXPERIMENTAL

Catheterization

Intervention Type PROCEDURE

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。

Single nerve block

Intervention Type PROCEDURE

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.

Continuous nerve block

Intervention Type PROCEDURE

After surgery,local anesthetics were injected continuously through catheters.Local anesthetic formula:Ropivacaine 300mg + normal saline, prepared into 150milliliters liquid, background dose 2milliliters/h.

PCIA

Intervention Type PROCEDURE

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

single RISS group

Patients were given single RISS plane block in addition to patient controlled intravenous analgesia.

Group Type EXPERIMENTAL

Single nerve block

Intervention Type PROCEDURE

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.

PCIA

Intervention Type PROCEDURE

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

PCIA group

Patients were given patient controlled intravenous analgesia.

Group Type ACTIVE_COMPARATOR

PCIA

Intervention Type PROCEDURE

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

Interventions

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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。

Intervention Type 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.

Intervention Type 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.

Intervention Type 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

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luo Fuchao

OTHER

Sponsor Role lead

Responsible Party

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Luo Fuchao

principal

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Luo fuchao, MD

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Fuling Hospital

Locations

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FulingCH

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Luo fuchao, MD

Role: CONTACT

+8613896658090

Facility Contacts

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Luo fuchao, MD

Role: primary

+86 13896658090

Other Identifiers

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RISS

Identifier Type: -

Identifier Source: org_study_id

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