Thoracic Outlet SyndromeBLOCKTOSNCT04471545
PECS II Block in Thoracic Outlet Decompression
A study testing Pectoral nerve block type II in people with Thoracic Outlet Syndrome, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
Rationale: Postoperative pain management after transaxillary thoracic outlet decompression surgery (TATOD) is difficult. In a retrospective case-control trial, we found evidence that a PECS II block is able to reduce pain and morphine consumption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Outlet Syndrome
- What is being tested?
- Pectoral nerve block type II
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Aug 2020to 3 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with NTOS
- Selected for a trans-axillary thoracic outlet decompression (TATOD) by the TOS multidisciplinary workgroup.
- Fit for surgery, defined as ASA (American Society of Anesthesiologists) Classification of I, II or III.
- 18 years of age or older
- Sufficient in speaking and writing the Dutch language
- Normal liver and renal function
- Informed consent
Who cannot join
- Patients with a history of TOD (Redo-surgery)
- Patients with ATOS or VTOS
- ASA ≥ 4
- Kidney or liver failure with contra-indication for NSAID or paracetamol
- Mental retardation
- Pregnancy
Show all 9Show fewer
- Patients with chronic strong opioid use (>3 administrations per week or continuous transdermal therapy, longer than the last 3 months)
- Allergy to one or more medications used in the study including, ropivacaine, dexamethasone, propofol, sufentanil, succinylcholine, paracetamol, NSAID, morphine, granisetron
- Patients that have trouble expressing themselves in Dutch. Questionnaires are completed by the patients and checked by the nurses. The questionnaire is in Dutch. If there is a language barrier between the questionnaire, the patient or the health care worker, we believe the validity of the answers is questionable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Pectoral Nerve Block Type II in Patients Undergoing Trans-axillary Thoracic Outlet Decompression
Rationale: Postoperative pain management after transaxillary thoracic outlet decompression surgery (TATOD) is difficult. In a retrospective case-control trial, we found evidence that a PECS II block is able to reduce pain and morphine consumption. This may ultimately lead to less morphine induced side-effects and improved patient satisfaction. However, the risk of bias in retrospective research is high. To determine the effect of PECS II in TATOD, a randomized controlled double blinded trial could offer more valuable scientific evidence. Our hypothesis is that a PECS II block will reduce pain, opioid use and opioid induced side-effects in patients undergoing transaxillary TOD (TATOD).
Objective: The aim of the study is to determine the effect of a PECS II block on postoperative pain and opioid use in patients undergoing TATOD. The secondary objective is to determine the effect of a PECS II block on opioid induced side effects such as postoperative nausea and vomitus and the quality of recovery Study design: Single centre randomized controlled double blinded trial Study population: All patients with Neurogenic Thoracic Outlet Syndrome (NTOS) selected for TATOD by the TOS multidisciplinary workgroup and based on the specifications in 2016 SVS reporting standards.
Read more
Intervention: The study group will receive a PECS II block with 40 ml ropivacaine 5 mg/ml. The control group will receive a PECS II block with 40 ml NaCL 0.9%.
Main study parameters/endpoints: Primary outcome parameters are postoperative pain using the Numeric Rated Scale (NRS) score assessed at rest and when moving and postoperative morphine-equivalent consumption. Secondary outcome parameters are postoperative Nausea and Vomitus (PONV) and Quality of Recovery questionnaire (QoR-15).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will undergo ultrasound guided injection, after induction of anaesthesia. The administration of the injection does not invoke any extra physical discom-fort. Possible complications include hematoma and pneumothorax, however, the risk is very low (<1%)[1]. In the intervention group, we expect less pain, a reduced need for pain medica-tion and less postoperative nausea and vomitus. We do not expect an altered postoperative course in the control group. Patients will be asked to fill out a questionnaire. Extra blood sam-ples, site visits, physical examinations or other test will not be done in this study.
- Conditions
- Thoracic Outlet Syndrome
- Being tested
- Pectoral nerve block type II
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoral nerve block type IIProcedure or surgery
A pectoral nerve block type II will be given to the patient after induction. This is performed ultrasound guided
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Intervention arm: PECS II block with ropivacaine Receives: Procedure: Pectoral nerve block type II |
| Control group | Placebo comparator | Control arm: PECS II block with placebo (saline) Receives: Procedure: Pectoral nerve block type II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Numeric Rated Scale
Pain is measured using the Numeric Rated Scale (NRS) for pain. This is a psychometric response scale in which patients are asked to rate their pain from 0 to 10 (no pain to extreme pain). This scale is a validated and generally accepted tool to measure pain.
Measured: Change pain NRS scale is measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge
Morphine Equivalent Dose (MED)
Opioid use is measured in Morphine Equivalent Dose (MED). This is a generally accepted tool to quantify opioid use in patients. We will focus on the total opioid consumption.
Measured: Total morphine equivalent dose is measured from date of admission until the date of discharge
Secondary outcomes (2)
Postoperative nausea and vomitus (PONV)
Postoperative nausea and/or vomitus (PONV) will be assessed by yes or no answer.
Measured: measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge
Quality of Recovery Scale - 15 (QoR-15)
The QoR-15 is a recently developed and validated patient-reported outcome measurement (PROM) of postoperative quality of recovery.
Fifteen questions assess five domains of patient-reported health status: pain, physical comfort, physical independence, psychological support and emotional state. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
Measured: measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start27 Aug 2020
- Primary completion1 Oct 2021
- Study completion3 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be done through Research manager©. This research program has the possibility to create randomisation logs before the start of the trial. A random list of numbers will be generated through Research manager© between 0 and 70. If the number is even, the patient will be allocated to the interventional treatment arm (PECS II block). If the number is uneven, the patient will be allocated to the placebo arm. This list will not be changed during the course of this investigation. Randomisation will be performed by an independent pharmacist from the hospital pharmacy before the start of the trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joep Teijink, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471545
- Sponsor's protocol ID
- NL72737.100.20
- Acronym
- BLOCKTOS
- Status last verified
- Mar 2022
- First submitted
- 5 Jul 2020
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
van den Broek RJC, Goeteyn J, Houterman S, Bouwman RA, Versyck BJB, Teijink JAW. Interpectoral-pectoserratus plane (PECS II) block in patients undergoing trans-axillary thoracic outlet decompression surgery; A prospective double-blind, randomized, placebo-controlled clinical trial. J Clin Anesth. 2022 Nov;82:110939. doi: 10.1016/j.jclinane.2022.110939. Epub 2022 Jul 27.
PubMed 35907370
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Pectoral Nerve Block Type II in Patients Undergoing Trans-axillary Thoracic Outlet Decompression
- ClinicalTrials.gov ID
- NCT04471545
- Acronym / sponsor ID
- BLOCKTOS / NL72737.100.20
- Conditions
- Thoracic Outlet Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 3 Oct 2021 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Postoperative pain management after transaxillary thoracic outlet decompression surgery (TATOD) is difficult. In a retrospective case-control trial, we found evidence that a PECS II block is able to reduce pain and morphine consumption. This may ultimately lead to less morphine induced side-effects and improved patient satisfaction. However, the risk of bias in retrospective research is high. To determine the effect of PECS II in TATOD, a randomized controlled double blinded trial could offer more valuable scientific evidence. Our hypothesis is that a PECS II block will reduce pain, opioid use and opioid induced side-effects in patients undergoing transaxillary TOD (TATOD).
Objective: The aim of the study is to determine the effect of a PECS II block on postoperative pain and opioid use in patients undergoing TATOD. The secondary objective is to determine the effect of a PECS II block on opioid induced side effects such as postoperative nausea and vomitus and the quality of recovery Study design: Single centre randomized controlled double blinded trial Study population: All patients with Neurogenic Thoracic Outlet Syndrome (NTOS) selected for TATOD by the TOS multidisciplinary workgroup and based on the specifications in 2016 SVS reporting standards.
Intervention: The study group will receive a PECS II block with 40 ml ropivacaine 5 mg/ml. The control group will receive a PECS II block with 40 ml NaCL 0.9%.
Main study parameters/endpoints: Primary outcome parameters are postoperative pain using the Numeric Rated Scale (NRS) score assessed at rest and when moving and postoperative morphine-equivalent consumption. Secondary outcome parameters are postoperative Nausea and Vomitus (PONV) and Quality of Recovery questionnaire (QoR-15).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will undergo ultrasound guided injection, after induction of anaesthesia. The administration of the injection does not invoke any extra physical discom-fort. Possible complications include hematoma and pneumothorax, however, the risk is very low (<1%)[1]. In the intervention group, we expect less pain, a reduced need for pain medica-tion and less postoperative nausea and vomitus. We do not expect an altered postoperative course in the control group. Patients will be asked to fill out a questionnaire. Extra blood sam-ples, site visits, physical examinations or other test will not be done in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will be done through Research manager©. This research program has the possibility to create randomisation logs before the start of the trial. A random list of numbers will be generated through Research manager© between 0 and 70. If the number is even, the patient will be allocated to the interventional treatment arm (PECS II block). If the number is uneven, the patient will be allocated to the placebo arm. This list will not be changed during the course of this investigation. Randomisation will be performed by an independent pharmacist from the hospital pharmacy before the start of the trial.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Procedure: Pectoral nerve block type IIIntervention arm: PECS II block with ropivacaine |
| Control group | Placebo comparator | Procedure: Pectoral nerve block type IIControl arm: PECS II block with placebo (saline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with NTOS
- Selected for a trans-axillary thoracic outlet decompression (TATOD) by the TOS multidisciplinary workgroup.
- Fit for surgery, defined as ASA (American Society of Anesthesiologists) Classification of I, II or III.
- 18 years of age or older
- Sufficient in speaking and writing the Dutch language
Key exclusion criteria (9 listed)
- Patients with a history of TOD (Redo-surgery)
- Patients with ATOS or VTOS
- ASA ≥ 4
- Kidney or liver failure with contra-indication for NSAID or paracetamol
- Mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pectoral nerve block type IIA pectoral nerve block type II will be given to the patient after induction. This is performed ultrasound guided | Procedure or surgery | Control group, Interventional group |
Primary outcome
Change in Pain Numeric Rated Scale
Time frame: Change pain NRS scale is measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge
Pain is measured using the Numeric Rated Scale (NRS) for pain. This is a psychometric response scale in which patients are asked to rate their pain from 0 to 10 (no pain to extreme pain). This scale is a validated and generally accepted tool to measure pain.
Morphine Equivalent Dose (MED)
Time frame: Total morphine equivalent dose is measured from date of admission until the date of discharge
Opioid use is measured in Morphine Equivalent Dose (MED). This is a generally accepted tool to quantify opioid use in patients. We will focus on the total opioid consumption.
2 secondary outcomes
Postoperative nausea and vomitus (PONV)
Time frame: measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge
Quality of Recovery Scale - 15 (QoR-15)
Time frame: measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Derived from this study: PubMed 35907370van den Broek RJC, Goeteyn J, Houterman S, Bouwman RA, Versyck BJB, Teijink JAW. Interpectoral-pectoserratus plane (PECS II) block in patients undergoing trans-axillary thoracic outlet decompression surgery; A prospective double-blind, randomized, placebo-controlled clinical trial. J Clin Anesth. 2022 Nov;82:110939. doi: 10.1016/j.jclinane.2022.110939. Epub 2022 Jul 27.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pectoral nerve block type II in people with Thoracic Outlet Syndrome, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Numeric Rated Scale (time frame: Change pain NRS scale is measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04471545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.