Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy

Esophagus Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06092944
• Other study ID #: RISS
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: Fuling Central Hospital of Chongqing City
• Contact: Luo fuchao, MD
• Phone: +8613896658090
• Email: luokyyx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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: ?~?;
• 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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Procedure:
• Catheterization
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?
• Single nerve block
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 nerve block
After surgery,local anesthetics were injected continuously through catheters.Local anesthetic formula:Ropivacaine 300mg + normal saline, prepared into 150milliliters liquid, background dose 2milliliters/h.
• PCIA
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

Locations

Country	Name	City	State
China	FulingCH	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Luo Fuchao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	dizziness	The occurrence of dizziness was recorded	24hours after surgery
Secondary	lethargy	The occurrence of lethargy was recorded	24hours after surgery
Secondary	nausea or vomiting	The occurrence of nausea /vomiting was recorded	24hours after surgery
Secondary	hypotension	The occurrence of hypotension was recorded	24hours after surgery
Secondary	respiratory depression	The occurrence of respiratory depression was recorded	24hours after surgery
Secondary	urinary retention	The occurrence of urinary retention was recorded	24hours after surgery
Secondary	Analgesia satisfaction	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.	24hours after surgery