Clinical trial NCT06092944: Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy
Official title: Clinical Study of Rhomboid Intercostal and Subserratum Plane Block for Postoperative Analgesia in Minimally Invasive Esophagectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophagus Cancer
Keywords: Rhomboid intercostal and subserratum plane block
Ultrasound-guided
Postoperative analgesia
Minimally invasive esophagectomy
Lead sponsor: Fuling Central Hospital of Chongqing City
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Analgesic effect
timeFrame: 2, 6, 12, 24, and 48 hours after surgery
measure: mean arterial pressure (MAP)
timeFrame: before anesthesia induction (T0)， before skin incision（T1）， 5 minutes after skin incision
measure: Heart rate (HR)
timeFrame: before anesthesia induction (T0)， before skin incision（T1）， 5 minutes after skin incision
Secondary outcomes:
measure: dizziness
timeFrame: 24hours after surgery
measure: lethargy
timeFrame: 24hours after surgery
measure: nausea or vomiting
timeFrame: 24hours after surgery
measure: hypotension
timeFrame: 24hours after surgery
measure: respiratory depression
timeFrame: 24hours after surgery
measure: urinary retention
timeFrame: 24hours after surgery
measure: Analgesia satisfaction
timeFrame: 24hours after surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: FulingCH
Study officials:
affiliation: Chongqing University Fuling Hospital
name: Luo fuchao, MD
role: PRINCIPAL_INVESTIGATOR
References: