Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy

Not Applicable

Recruiting

• Conditions: Esophagus Cancer
• Interventions: Procedure: PCIA; Procedure: Catheterization; Procedure: Single nerve block; Procedure: Continuous nerve block

• Registration Number: NCT06092944
• Lead Sponsor: Luo Fuchao

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.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-09-27
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-16
• Last Update Submitted: 2023-10-16
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCIA group	PCIA	Patients were given patient controlled intravenous analgesia.
continuous RISS group	PCIA	Patients were given continuous RISS plane block in addition to patient controlled intravenous analgesia.
continuous RISS group	Catheterization	Patients were given continuous RISS plane block in addition to patient controlled intravenous analgesia.
single RISS group	Single nerve block	Patients were given single RISS plane block in addition to patient controlled intravenous analgesia.
continuous RISS group	Single nerve block	Patients were given continuous RISS plane block in addition to patient controlled intravenous analgesia.
continuous RISS group	Continuous nerve block	Patients were given continuous RISS plane block in addition to patient controlled intravenous analgesia.
single RISS group	PCIA	Patients were given single RISS plane block in addition to patient controlled intravenous analgesia.

Primary Outcome Measures

Name	Time	Method
Analgesic effect	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)	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)	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 Outcome Measures

Name	Time	Method
nausea or vomiting	24hours after surgery	The occurrence of nausea /vomiting was recorded
hypotension	24hours after surgery	The occurrence of hypotension was recorded
dizziness	24hours after surgery	The occurrence of dizziness was recorded
lethargy	24hours after surgery	The occurrence of lethargy was recorded
urinary retention	24hours after surgery	The occurrence of urinary retention was recorded
respiratory depression	24hours after surgery	The occurrence of respiratory depression was recorded
Analgesia satisfaction	24hours after surgery	patient will be asked to rate their Satisfaction with analgesia using verbal rating scales (VRS) .Scores from 1 to 5 represent very dissatisfied, not satisfied, basically satisfied, relatively satisfied, and very satisfied with the analgesic effect, respectively.

Trial Locations

Locations (1)

FulingCH; 🇨🇳 Chongqing, China