- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462273
RISS Block for Enhanced Recovery After Video-Assisted Thoracoscopic Surgery
A Prospective Randomized Controlled Trial Evaluating the Efficacy and Safety of Ultrasound-Guided Rhomboid Intercostal and Subserratus Plane Block for Enhanced Recovery After Video-Assisted Thoracoscopic Surgery
This prospective randomized controlled trial evaluates the efficacy and safety of ultrasound-guided rhomboid intercostal and subserratus plane (RISS) block for postoperative analgesia in patients undergoing video-assisted thoracoscopic surgery (VATS).
Postoperative pain after VATS can impair respiratory function, delay mobilization, and increase opioid consumption. Although several regional anesthesia techniques are available, the optimal analgesic strategy remains under investigation. The RISS block is a novel fascial plane block that may provide effective thoracic analgesia while minimizing opioid-related adverse effects.
A total of 90 adult patients scheduled for elective VATS will be randomly assigned to receive either ultrasound-guided RISS block combined with general anesthesia or general anesthesia alone. The primary outcomes include postoperative 24-hour benefit of analgesia score (BCS) and patient-controlled intravenous analgesia (PCIA) pressing frequency. Secondary outcomes include postoperative pain scores, opioid consumption, and adverse events.
This study aims to determine whether RISS block improves postoperative recovery and reduces opioid requirements after VATS.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ningbo, China
- The Affiliated Hospital of Ningbo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Adults aged 18 years or older
ASA physical status I-II
Scheduled for elective video-assisted thoracoscopic surgery (VATS)
Provided written informed consent
Exclusion Criteria:
History of shock or coma
Coagulopathy
Local infection at the puncture site
Pre-existing nerve injury on the side intended for block
Chronic analgesic use
Psychiatric disorders
Prior thoracic or breast surgery
Allergy to local or general anaesthetic agents
Body mass index (BMI) ≥35 kg/m²
Inability to operate a patient-controlled analgesia (PCA) device
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
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Experimental: RISS Block Group
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Ultrasound-guided dual-plane RISS block performed after induction of general anesthesia.
A total of 40 mL of 0.375% ropivacaine (150 mg) was administered across the rhomboid-intercostal plane and low subserratus plane.
|
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Experimental: ICNB Group
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Ultrasound-guided intercostal nerve block performed at surgical port levels (T4-T7) using 0.375% ropivacaine with total dose ≤75 mg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
24-hour cumulative number of effective PCA presses
Time Frame: Within 24 hours postoperatively
|
Within 24 hours postoperatively
|
|
Bruggrmann Comfort Scale (BCS) score at 24 hours
Time Frame: 24 hours after surgery
|
24 hours after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Anesthetics
- Central Nervous System Depressants
- Sensory System Agents
- Pharmacologic Actions
- Chemical Actions and Uses
- Therapeutic Uses
- Central Nervous System Agents
- Anesthetics, Local
Other Study ID Numbers
- 2024-scientific-research-124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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