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Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06092944
Enrollment
96
Registered
2023-10-23
Start date
2023-03-01
Completion date
2024-12-30
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagus Cancer

Keywords

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

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.

Interventions

PROCEDURECatheterization

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。

PROCEDURESingle 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.

After surgery,local anesthetics were injected continuously through catheters.Local anesthetic formula:Ropivacaine 300mg + normal saline, prepared into 150milliliters liquid, background dose 2milliliters/h.

PROCEDUREPCIA

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

Sponsors

Luo Fuchao
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Analgesic effect2, 6, 12, 24, and 48 hours after surgerypatient 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)
mean arterial pressure (MAP)before anesthesia induction (T0), before skin incision(T1), 5 minutes after skin incisionThe mean arterial pressure (MAP)on the monitor at different times was recorded.
Heart rate (HR)before anesthesia induction (T0), before skin incision(T1), 5 minutes after skin incisionThe Heart rate (HR)on the monitor at different times was recorded.

Secondary

MeasureTime frameDescription
dizziness24hours after surgeryThe occurrence of dizziness was recorded
lethargy24hours after surgeryThe occurrence of lethargy was recorded
nausea or vomiting24hours after surgeryThe occurrence of nausea /vomiting was recorded
hypotension24hours after surgeryThe occurrence of hypotension was recorded
respiratory depression24hours after surgeryThe occurrence of respiratory depression was recorded
urinary retention24hours after surgeryThe occurrence of urinary retention was recorded
Analgesia satisfaction24hours after surgerypatient 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.

Countries

China

Contacts

Primary ContactLuo fuchao, MD
luokyyx@163.com+8613896658090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026