RCT Impact of Serratus Intercostal Plane Block in Video Assisted Thoracic Surgery

NCT03449329 | Completed

• 1 other identifier: RCT impact of SIPblock
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale Video Assisted Thoracic Surgery (VATS) is known to be a moderate painful procedure. There are many ways to manage postoperative pain following this kind of surgery. One of the 'golden standards' nowadays is epidural analgesia using Patient Controlled Epidural Analgesia (PCEA). Patient Controlled Intravenous Analgesia (PCIA) is also an option, as are several kinds of regional anesthesia. One of the most recent described regional blocks is the Serratus Anterior Plane block (SAP), also called Serratus Intercostal Plane (SIP) block. Objectives The objective of this study is to evaluate the efficacy and opioid sparing effect of a SIP block in postoperative pain relief after VATS. Hypotheses Patients receiving a SIP block prior to surgery need less opioids during and 24h after VATS compared with patients who didn't receive a SIP block. Study design Single center randomized controlled trial Study population Patients older than 18 years old scheduled for VATS. Main study parameters/endpoints The primary endpoint is the opioid use during the first 24 hours after start of surgery. Secondary endpoints are the VAS score on day 0 and day 1 after surgery, and the prevalence of postoperative nausea and vomiting (PONV). Nature and extent of the burden and risks associated with participation, benefit and group relatedness In the intra-operative period, patients will not experience discomfort from either strategy because of general anesthesia. If the hypothesis proves to be true, patients with SIP block could benefit from a lower amount of received opioids, which could give less chance of opioid associated adverse effects. There won't be any additional blood sampling related to this study.

Conditions

Anesthesia, Conduction

Outcome Measures

Primary Outcomes (1)

• Opioid consumption during the first 24 hours postoperative

  total dose of opioids given

  first 24 hours postoperative (after wound closure)

Secondary Outcomes (1)

• Intraoperative opioid consumption

  intra operative (from incision till wound closure)

Study Arms (2)

placebo SIP block

PLACEBO COMPARATOR

This group will receive a placebo SIP block injection with 60mL NaCl 0.9%

Procedure: SIP

Locoregional SIP block

ACTIVE COMPARATOR

This group will receive a SIP block using: 3mg/kg Ropivacain 1% 1mcg/kg dexmedetomidine (Dexdor®) 100mcg/ml Addition of NaCl 0.9% up to 60ml

Procedure: SIP

Interventions

SIP PROCEDURE

The intervention group will receive a SIP block

Locoregional SIP block; placebo SIP block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled for thoracoscopic surgery

You may not qualify if:

• urgent surgery
• allergic to Sufentanil or Ropivacaine

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

Azsintjan

Bruges, 8000, Belgium

Location

Study Officials

• Marco Lanckneus, MD

  AZ Sint Jan Brugge-Oostende

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of anesthesiology,

Model Details: double blinded randomized two study group

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 28, 2018
• Study Start: April 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: July 31, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)