AzTrials
AzTrials

Pain, PostoperativePhase 4NCT02544282

Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery

A Phase 4 study testing Levobupivacaine, NaCl 0.9% and Sevoflurane in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by GZA Ziekenhuizen Campus Sint-Augustinus at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In this prospective trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to general anesthesia with opioids combined with a Pecs II block or to general anesthesia with opioids combined with a placebo Pecs II block. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
What is being tested?
Levobupivacaine, NaCl 0.9% and Sevoflurane
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
1 siteBelgium
Study dates
Apr 2014to Mar 2016
Phase
Phase 4
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 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)
  • Scheduled for unilateral or bilateral mastectomy with or without implant (isolated "lumpectomy" will not qualify)
  • Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least five nodes)
  • Written informed consent, including willingness to be randomized to opioids or regional analgesia
  • Dutch speaking

Who cannot join

  • Previous surgery for breast cancer (except diagnostic biopsies)
  • Inflammatory breast cancer
  • Scheduled free flap reconstruction
  • ASA Physical Status ≥ 4
  • Any contraindication to locoregional analgesia (including coagulopathy, abnormal anatomy)
  • Any contraindication to midazolam, propofol, sevoflurane, sufentanyl, tramadol or piritramide
Show all 17Show fewer
  • Other cancer not believed by the attending surgeon to be in long-term remission
  • Systemic disease believed by the attending surgeon to present ≥ 25% two-year mortality
  • Obesity defined as BMI ≥ 30 kg/m2
  • Chronic use of pain medication (started > 3 months ago)
  • Allergic to Chirocaine
  • Chronic drug or alcohol abuse
  • INR > 1.4
  • Thrombocytopenia < 70,000 platelets
  • Dementia
  • Pregnancy
  • Kidney or liver failure

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • GZA Sint Augustinus

    Wilrijk, Antwerpen, 2610

Other trials in Belgium

About this study

Official title: Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery: Effect on Postoperative Pain and Opioid Consumption

In this prospective trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to general anesthesia with opioids combined with a Pecs II block or to general anesthesia with opioids combined with a placebo Pecs II block. Participants will be followed postoperatively during their entire hospital stay to determine the effectiveness of Pecs II block and opioids versus placebo Pecs II block and opioids as postoperative pain treatment.

Read the detailed description

Each year, 9400 new cases of breast cancer are diagnosed in Belgium. It makes breast cancer the most common cancer in women, good for more than one third of all cancer cases in women.

Surgical excision of the tumour is a necessary and effective step to cure from the disease. Recent studies have demonstrated the positive effects of regional anesthesia on peroperative and postoperative pain. Paravertebral blocks have become popular as an alternative to the analgesia provided by the 'gold standard' of thoracic epidural analgesia. However, both regional techniques have complications and slow learning curves that make them unsuitable for the large proportion of breast surgery patients who are treated on a day-stay basis. Recently, Rafael Blanco introduced the Pecs and Pecs II blocks, a practical alternative to both paravertebral and epidural blockade in the management of pain after breast surgery.

The investigators introduced the Pecs II block in their clinical practice. This study compares general anesthesia with a Pecs II block to general anesthesia with a placebo Pecs II block for breast surgery. The objective is to evaluate analgesic effectiveness and changes in opioid consumption when applying a Pecs II block versus a placebo Pecs II block.

Stage 1-3 patients having mastectomies or tumourectomies with axillary clearance will be randomly assigned to general anesthesia with a Pecs II block or to general anesthesia with a placebo Pecs II block. Enrolling 140 patients over an anticipated time frame of 2 years will provide an 90% power and a p-value of 0.05 for perioperative and postoperative opioid consumption as well as pain scores (NRS). Confirming the hypothesis will indicate that a minor modification to the anesthetic procedure will reduce the opioid consumption (including it's unwanted side effects) during and after surgery while maintaining or reducing patients' indicated pain scores (NRS).

Being tested
Levobupivacaine, NaCl 0.9%, Sevoflurane, Propofol, Sufentanil
Keywords
Analgesics, Opioid, Mastectomy, Segmental Mastectomy, Pecs II
Medical subject headings
Pain, Postoperative, Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevobupivacaineDrug

    Also called Chirocaine

    Pecs II Block

  • NaCl 0.9%Drug

    Also called Normal Saline

    Placebo Pecs II block

  • SevofluraneDrug

    General Anesthesia

  • PropofolDrug

    General Anesthesia

  • SufentanilDrug

    General Anesthesia

  • AtracuriumDrug

    General Anesthesia

  • ParacetamolDrug

    Also called Acetaminophen

    Pain Relief

  • TramadolDrug

    Pain Relief

  • PiritramideDrug

    Pain Relief

Study groups in NCT02544282
Study groupRoleWhat they receive
Pecs IIActive comparatorGeneral anesthesia followed by a Pecs II block and opioids if required
Receives: Drug: Levobupivacaine; Drug: Sevoflurane; Drug: Propofol; Drug: Sufentanil; Drug: Atracurium; Drug: Paracetamol; Drug: Tramadol; Drug: Piritramide
PlaceboPlacebo comparatorGeneral anesthesia followed by a placebo Pecs II block and opioids if required
Receives: Drug: NaCl 0.9%; Drug: Sevoflurane; Drug: Propofol; Drug: Sufentanil; Drug: Atracurium; Drug: Paracetamol; Drug: Tramadol; Drug: Piritramide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain

    Within first hour: Each ten minutes by Recovery Nurse. Hour 2 till discharge ( max 72 hours post surgery): hourly by patient through questionnaire.Master data set is administrated by secretarial office of Anesthesia departement

    Measured: up to 72 hours after completion of surgery

Secondary outcomes (3)

  1. Peroperative Opioid Consumption

    Anesthetist in charge reports Opioid Consumption. Master data set is administrated by secretarial office of Anesthesia department

    Measured: Peroperative period (max. 5 hours)

  2. Postoperative Opioid Consumption

    Nurse of postoperative recovery room and nurse of ward in charge reports opioid consumption on patient questionnaire. Master data set is administrated by secretarial office of Anesthesia department

    Measured: up to 72 hours after completion of surgery

  3. Postoperative Nausea and Vomiting

    Nurse of postoperative recovery room and nurse of ward in charge reports patients nausea and vomiting as well as the administered medication against postoperative nausea and vomiting on patient questionnaire. Master data set is administrated by secretarial office of Anesthesia department

    Measured: up to 72 hours after completion of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

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 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02544282
Sponsor's protocol ID
GZA-ANE-PECS-01
Status last verified
Oct 2015
First submitted
2 Sep 2015
Last updated
13 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

    PubMed 22939099

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Levobupivacaine, NaCl 0.9% and Sevoflurane in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by GZA Ziekenhuizen Campus Sint-Augustinus at 1 site in Belgium.

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 5 inclusion and 17 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 13 Jul 2016. 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 Belgium. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Postoperative Pain (time frame: up to 72 hours after completion of surgery). 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 NCT02544282, 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 13 Jul 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT02544282 | AzTrials