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Clinical Trials/NCT07462273
NCT07462273
Completed
Not Applicable

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

Ningbo University1 site in 1 country90 target enrollmentStarted: September 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Ningbo University
Enrollment
90
Locations
1
Primary Endpoint
24-hour cumulative number of effective PCA presses

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

RISS Block Group

Experimental

Intervention: Rhomboid Intercostal and Subserratus Plane Block with local anesthetic (Procedure)

ICNB Group

Experimental

Intervention: Intercostal nerve block (Procedure)

Control Group

No Intervention

Outcomes

Primary Outcomes

24-hour cumulative number of effective PCA presses

Time Frame: Within 24 hours postoperatively

Bruggrmann Comfort Scale (BCS) score at 24 hours

Time Frame: 24 hours after surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ningbo University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lei Shi

Professor

Ningbo University

Study Sites (1)

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