Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: continuous RISS group Patients were given continuous RISS plane block in addition to patient controlled intravenous analgesia. |
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。
Procedure: 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.
Procedure: 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.
Procedure: 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
|
| Experimental: single RISS group Patients were given single RISS plane block in addition to patient controlled intravenous analgesia. |
Procedure: 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.
Procedure: 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
|
| Active Comparator: PCIA group Patients were given patient controlled intravenous analgesia. |
Procedure: 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
|
Outcome Measures
Primary Outcome Measures
- 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)
- 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.
- 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.
Secondary Outcome Measures
- dizziness [24hours after surgery]
The occurrence of dizziness was recorded
- lethargy [24hours after surgery]
The occurrence of lethargy was recorded
- nausea or vomiting [24hours after surgery]
The occurrence of nausea /vomiting was recorded
- hypotension [24hours after surgery]
The occurrence of hypotension was recorded
- respiratory depression [24hours after surgery]
The occurrence of respiratory depression was recorded
- urinary retention [24hours after surgery]
The occurrence of urinary retention 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients received MIE-McKeown surgery and were confirmed by postoperative pathology; Age 18-75 years old
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body mass index (BMI) : 18.5~23.9kg/m2;
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American Society of Anesthesiologists (ASA) grade: Ⅰ~Ⅱ;
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Clear consciousness, no cognitive impairment;
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Patients informed to participate in the study and signed informed consent.
Exclusion Criteria:
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Infection of the puncture site, abnormal platelet or coagulation function;
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Patients with drug allergy involved in this study;
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Long-term use of analgesic, sedative drugs or a history of heavy drinking;
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Patients with chronic painful diseases;
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With severe heart, liver, kidney and lung dysfunction;
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Infectious diseases, blood, immune, circulatory system diseases; -Communication barriers, can not cooperate with the scale assessment; -
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Other situations not suitable for this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | FulingCH | Chongqing | China |
Sponsors and Collaborators
- Luo Fuchao
Investigators
- Principal Investigator: Luo fuchao, MD, Chongqing University Fuling Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RISS