Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy

NCT06092944 | Unknown

• 1 other identifier: RISS
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Esophagus Cancer

Keywords

Rhomboid intercostal and subserratum plane block; Ultrasound-guided; Postoperative analgesia; Minimally invasive esophagectomy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• dizziness

  24hours after surgery

• lethargy

  24hours after surgery

• nausea or vomiting

  24hours after surgery

• hypotension

  24hours after surgery

• respiratory depression

  24hours after surgery

Study Arms (3)

continuous RISS group

EXPERIMENTAL

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

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

single RISS group

EXPERIMENTAL

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

Procedure: Single nerve block; Procedure: PCIA

PCIA group

ACTIVE COMPARATOR

Patients were given patient controlled intravenous analgesia.

Procedure: PCIA

Interventions

Catheterization 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。

continuous RISS group

Single nerve block 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 RISS group; single RISS group

Continuous nerve block 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.

continuous RISS group

PCIA 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; continuous RISS group; single RISS group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luo Fuchao: lead

Study Sites (1)

FulingCH

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Catheterization; Nerve Block

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Luo fuchao, MD

  Chongqing University Fuling Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luo fuchao, MD

CONTACT

+8613896658090; luokyyx@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 23, 2023
• Study Start: March 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)