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

November 17, 2019 updated by: Jan Mulier, AZ Sint-Jan AV

Randomised Controlled Double Blinded Trial Analyzing Impact of Serratus Intercostal Plane Block in Video Assisted Thoracic Surgery on Postoperative Pain and Recovery.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed randomized controlled trial aims at comparing the opioid use per- and postoperatively in patients with versus without SIP block undergoing VATS.

We hypothesize that use of a SIP block results in less opioid use during and the first 24 hours after VATS as compared with patients without SIP block.

Single center randomized controlled trial on patients undergoing VATS under general anesthesia.

We intend to recruit patients scheduled for elective VATS in our hospital during a period of 3 months. Surgical patients will be screened twice a week, because there are two days a week that VATS procedures take place in our hospital. We will randomize 20 patients, based on the power analysis (cfr infra).

Inclusion criteria: Patients scheduled for VATS under general anesthesia Exclusion criteria

  • Age < 18 years
  • Urgent surgery
  • Allergy to sufentanil or ropivacain
  • Postoperative need for invasive ventilation within 24hours after surgery

Sample size calculation was based on our primary hypothesis and primary study outcome, and was informed by data collected in patients who underwent VATS procedures in our hospital during the previous six months. These calculations indicate that 14 patients need to be included, assuming a significance level of 0.05 and a power of 80%, to detect the expected difference in per- and postoperative opioid use between the SIP-group and the placebo group.

Main study parameter/endpoint: Opioid use during the first 24 hours after end of surgery Secondary study parameters/endpoints

  • VAS score on day 0 and day 1
  • Postoperative nausea and vomiting (PONV)

Surgical patients in our hospital will be considered eligible if they fulfill the entry criteria. Eligible patients will be screened, their demographic data recorded (registry: age, gender, type of surgery) and those without exclusion criteria will be randomized. In total, 20 patients will be included.

Patient Consent All patients or legal guardians must provide written informed consent according to local regulations before inclusion in the study.

Randomization will be performed using a sealed envelope system. Randomization arms Before surgery patients will be randomly assigned 1:1 to a placebo SIP block or to a real SIP block. All investigators involved intra- and postoperative are blinded. An independent anesthesia nurse not involved peri-operatively is asked to prepare the drugs in a different location according to the info kept in a sealed envelope. This envelope remains sealed in the patient files to be broken if an adverse event happens.

After induction of anesthesia and before surgery, each patient will receive an injection in between the serratus anterior and the intercostal muscle. The injection will be localized in the midaxillary line, between the 4th and 5th rib. The intervention group will receive a total amount of 60cc which consists of:

  • 3mg/kg Ropivacain 1%
  • 1mcg/kg dexmedetomidine (Dexdor®) (ampul with 2 ml contains 100mcg/ml)
  • Addition of NaCl 0.9% up to 60ml The control group will receive an injection of 60cc NaCl 0.9% at the same injection site of the SIP block.

Each patient will receive 5-15mcg sufentanil (Sufenta®) before induction of anesthesia, depending on the personal choice of the anesthesiologist. To induce anesthesia, patients will receive 2mg/kg propofol 1% (Propofol®), and if not sufficient, a supplemental bolus will be given. To receive adequate neuromuscular blockage, at least 0.6mg/kg rocuroniumbromide 1% (Esmeron®) will be used.

Starting from insicion, depending on the personal choice of the performing anesthesiologist or based on ANI monitoring, a supplemental bolus sufentanil will be given if considered necessary. Routine intra-operative monitoring should include noninvasive blood pressure measurements, pulse oximetry, end-tidal carbon dioxide fraction and electrocardiography. Every patient should receive at least one peripheral venous line to allow adequate fluid resuscitation during the study period. Nasogastric tubes, urinary bladder catheters and/or other intravenous catheters, as well as other, more invasive monitoring may be used according to local practice and/or guidelines.

All patients receive a PCIA pump with sufentanyl and the dose requested and given is measured for the first and the second day. Patients receive paracetamol 1 gram every 6 hours.

Data to be collected

Pre-operative variables will be collected at the pre-anesthetic visit or before induction of general anesthesia:

Intra-operative variables will be collected after induction of anesthesia and during surgery:

Postoperative variables will be collected with a patient questionnaire and clinical examination, both on day 0 en 1 after surgery. Following variables will be collected:

Patient characteristics will be compared and described by appropriate statistics. The analysis will be performed with STATA or SPSS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • Azsintjan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients scheduled for thoracoscopic surgery

Exclusion Criteria:

  • urgent surgery
  • allergic to Sufentanil or Ropivacaine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: placebo SIP block
This group will receive a placebo SIP block injection with 60mL NaCl 0.9%
Procedure: SIP
The intervention group will receive a SIP block
ACTIVE_COMPARATOR: Locoregional SIP block

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
The intervention group will receive a SIP block

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opioid consumption during the first 24 hours postoperative
Time Frame: first 24 hours postoperative (after wound closure)
total dose of opioids given
first 24 hours postoperative (after wound closure)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraoperative opioid consumption
Time Frame: intra operative (from incision till wound closure)
total dose of opioids used intra operative
intra operative (from incision till wound closure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AZ Sint-Jan AV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Marco Lanckneus, MD, AZ Sint Jan Brugge-Oostende

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCT impact of SIPblock

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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