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Clinical Trials/NCT06092944
NCT06092944
Recruiting
Not Applicable

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

Luo Fuchao1 site in 1 country96 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophagus Cancer
Sponsor
Luo Fuchao
Enrollment
96
Locations
1
Primary Endpoint
Analgesic effect
Status
Recruiting
Last Updated
2 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Luo Fuchao
Responsible Party
Sponsor Investigator
Principal Investigator

Luo Fuchao

principal

Fuling Central Hospital of Chongqing City

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Analgesic effect

Time Frame: 2, 6, 12, 24, and 48 hours after surgery

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)

Heart rate (HR)

Time Frame: before anesthesia induction (T0), before skin incision(T1), 5 minutes after skin incision

The Heart rate (HR)on the monitor at different times was recorded.

mean arterial pressure (MAP)

Time Frame: before anesthesia induction (T0), before skin incision(T1), 5 minutes after skin incision

The mean arterial pressure (MAP)on the monitor at different times was recorded.

Secondary Outcomes

  • nausea or vomiting(24hours after surgery)
  • hypotension(24hours after surgery)
  • dizziness(24hours after surgery)
  • lethargy(24hours after surgery)
  • urinary retention(24hours after surgery)
  • respiratory depression(24hours after surgery)
  • Analgesia satisfaction(24hours after surgery)

Study Sites (1)

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