Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy

Luo Fuchao

Status: Enrolling

Conditions: Esophagus Cancer

Treatments: Procedure: PCIA; Procedure: Catheterization; Procedure: Single nerve block; Procedure: Continuous nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT06092944

RISS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 3 patient groups

continuous RISS group

Experimental group

Description:

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

Treatment:

Procedure: Single nerve block

Procedure: Catheterization

Procedure: Continuous nerve block

Procedure: PCIA

single RISS group

Experimental group

Description:

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

Treatment:

Procedure: Single nerve block

Procedure: PCIA

PCIA group

Active Comparator group

Description:

Patients were given patient controlled intravenous analgesia.

Treatment:

Procedure: PCIA