NCT07462273

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2024

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 5, 2026

Last Update Submit

March 5, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 24-hour cumulative number of effective PCA presses

    Within 24 hours postoperatively

  • Bruggrmann Comfort Scale (BCS) score at 24 hours

    24 hours after surgery

Study Arms (3)

RISS Block Group

EXPERIMENTAL
Procedure: Rhomboid Intercostal and Subserratus Plane Block with local anesthetic

ICNB Group

EXPERIMENTAL
Procedure: Intercostal nerve block

Control Group

NO INTERVENTION

Interventions

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.

RISS Block Group

Ultrasound-guided intercostal nerve block performed at surgical port levels (T4-T7) using 0.375% ropivacaine with total dose ≤75 mg.

ICNB Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older
  • ASA physical status I-II
  • Scheduled for elective video-assisted thoracoscopic surgery (VATS)
  • Provided written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Ningbo University

Ningbo, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 10, 2026

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations