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Pain, PostoperativePhase 3PABLOSNCT05345639

Chest Wall Block After Sternotomy: Randomized Controlled Trial in Cardiac Surgery: (PABLOS Study)

A Phase 3 study testing LRA Loco-regional anesthesia and Standardized post-operative analgesia protocol in people with Pain, Postoperative and Cardiac Surgery, run by University Hospital, Angers at 1 site in France.

Completed

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

Official record
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Trial summary

The main objective is to compare the effectiveness of LocoRegional Anesthesia (LRA) (bilateral transverse thoracic block or bilateral parasternal block) in addition to standard management compared to standard management alone (general anesthesia without LRA) on the FQoR-15 (French Quality of Recovery - 15 score) at… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Pain, Postoperative, Cardiac Surgery
What is being tested?
LRA Loco-regional anesthesia and Standardized post-operative analgesia protocol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
254 participants
Where
1 siteFrance
Study dates
1 Aug 2022to 7 Sep 2023
Phase
Phase 3
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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Pre-inclusion criteria :

  • Adult patient (≥18 years old);
  • Patient having scheduled cardiac surgery with a sternotomy performed at the CHU d'Angers;
  • Patient having signed a consent;
  • French-speaking patient, able to understand and answer a questionnaire;
  • Affiliated patient or beneficiary of a social security scheme.

Criteria for confirming inclusion

  • Hemodynamic stability at the end of surgery;
  • Absence of bleeding justifying immediate revision surgery.

Non-inclusion criteria

  • Known hypersensitivity to amide-bonded local anesthetics;
  • Operation for cardiac revision surgery, including sternotomy REDUX (revision surgery);
  • Emergency surgery;
  • Surgery in a septic context (Endocarditis, Intravascular device infection);
  • Weight less than 30kg;
  • Severe psychiatric or cognitive impairment interfering with assessment by questionnaires;
  • Pregnant, breastfeeding or parturient woman;
  • Person deprived of liberty by judicial or administrative decision;
  • A person undergoing psychiatric treatment under duress;
  • Person subject to a measure of legal protection;
  • Inclusion in another interventional study modifying postoperative pain management.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Jeanneteau

    Angers, maine et loire, 49933

Other trials in France

About this study

The main objective is to compare the effectiveness of LocoRegional Anesthesia (LRA) (bilateral transverse thoracic block or bilateral parasternal block) in addition to standard management compared to standard management alone (general anesthesia without LRA) on the FQoR-15 (French Quality of Recovery - 15 score) at H+24 after cardiac surgery by sternotomy.This is a phase III monocentric superiority study , comparative, with three parallel groups, randomized with a ratio (1:1:1), controlled versus standard management, single-blind.

Read the detailed description

Each year, more than one million patients worldwide undergo cardiac surgery via sternotomy. Postoperative pain is frequent in this context, affecting 49% of patients at rest and 78% during mobilization. This pain is associated with many avoidable post-operative complications.

Nowadays, ERAS (Enhanced Rehabilitation After Surgery) protocols are increasingly developed in order to optimize post-operative rehabilitation. The management of postoperative pain is one of their main challenges and is based in particular on the use of locoregional anesthesia (LRA) with the aim of sparing morphine.

Several LRAs have been described in cardiac surgery in recent years, and they are increasingly used in routine clinical practice. Transverse thoracic block and parasternal block are the main peripheral LRA techniques proposed for surgical procedures with sternotomy. Transverse chest block was first described in cardiac surgery in 2015 ; and the parasternal block in 2018. These techniques are spreading in current clinical practice because of their simplicity of implementation, their safety and their supposed effectiveness. The parasternal block is more recent, and presents a more superficial injection plane than the transverse thoracic block. Thus, it is theoretically as effective as the transverse thoracic and less at risk of complications.

The main objective of this study is to compare the effectiveness of LRA (bilateral transverse thoracic block or bilateral parasternal block) in addition to standard management compared to standard management alone (general anesthesia without LRA) on the quality of early postoperative recovery after heart surgery by sternotomy.

The primary endpoint is the postoperative recovery score in the French version, FQoR-15 (French Quality of Recovery - 15 score), performed at H+24. The FQoR-15 is currently one of the most reliable and reproducible tools for assessing the quality of postoperative rehabilitation. This instrument is one of the recommended endpoints for the evaluation of patient comfort, according to a recent consensus of international experts.

This study is a phase III study of superiority, monocentric, comparative, with three parallel groups, randomized with a ratio (1:1:1), controlled versus standard care, single-blind. of inclusion is 254 patients included and randomized.

The patient is pre-included during the pre-anaesthetic visit, the day before his scheduled surgery. He receives oral and written information, and provides his written consent to participate in this study, the follow-up will be 30 days. Depending on the randomization, the patient receives one of the following three treatments:

  1. bilateral transverse thoracic block followed by standard analgesic management;
  2. a bilateral parasternal block followed by standard analgesic treatment;
  3. standard analgesic treatment alone (without LRA). Bilateral parasternal block or transverse thoracic block are performed ultrasound-guided, at the end of surgery in the operating room. Once in the desired plane depending on the randomisation (transverse or parasternal), a volume of 20 ml of ropivacaine at 2 mg/ml is injected on each side of the sternum. The rest of the pain management is identical in the three groups according to the habits of the department.

If the hypotheses on the effectiveness of parasternal block and/or transverse thoracic block are confirmed, postoperative recovery in the interventional arms will be improved. This will confirm the value of performing an LRA postoperatively.

Being tested
LRA Loco-regional anesthesia, Standardized post-operative analgesia protocol
Keywords
LRA, Block, ERAS, FQOR-15, QOR-15, Transversus thoracic block, Parasternal block, Cardiac surgery, Analgesia, PIP (parasternal intercostal plane block), Régional anesthesia
Medical subject headings
Pain, Postoperative, Bites and Stings, Agnosia

What participants receive

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

  • LRA Loco-regional anesthesiaDrug

    Also called 40ml Ropivacaine 0.2%

    Bilateral parasternal block or transverse thoracic block are performed ultrasound-guided, at the end of surgery in the operating room. Once in the desired plane depending on the randomisation (transverse or parasternal), a volume of 20 ml of ropivacaine at 2 mg/ml is injected on each side of the sternum.

    The intervention (TTP or PSB) is performed by the anesthetist-resuscitator investigator.

  • Standardized post-operative analgesia protocolProcedure or surgery

    The pain management protocol in intensive care is as follows:

    • paracetamol 1g x 4 per day systematically (apart from the usual contraindications), IV then PO;
    • PCA (Patient Controlled Analgesia) with oxycodone or morphine: 1mg bolus, 7min refractory period, maximum 4h dose 20mg.

    The PCA is usually maintained until 24-48h after the intervention then relayed by oxycodone 5mg every 4h if EVA > 3 sublingual and addition of oxycodone LP 10mg x 2 per day if daily intake on PCA > 20mg.

    Remedy molecules in case of ineffective analgesia:

    ketoprofen 100mg q12h IV, or 50mg q8h PO; nefopam 20mg every 6h IV or PO; ketamine 1 to 1.5 mg/kg/24H IVSE.

Study groups in NCT05345639
Study groupRoleWhat they receive
TTP group (= Transversus Thoracic Plane block = Deep PIP = Deep parasternal intercostal plane block)ExperimentalAt the end of the surgery, realisation of a bilateral transverse thoracic block. (20ml of Naropeine 0.2%, each side) Followed by standard analgesic treatment.
Receives: Drug: LRA Loco-regional anesthesia; Procedure: Standardized post-operative analgesia protocol
PSB group (=ParaSternal Block = Superficial PIP = Superficial parasternal intercostal plane block)ExperimentalAt the end of the surgery, realisation of a bilateral parasternal block (20ml of Naropeine 0.2%, each side). Followed by standard analgesic treatment.
Receives: Drug: LRA Loco-regional anesthesia; Procedure: Standardized post-operative analgesia protocol
Control groupSham comparatorStandard analgesic treatment alone (without LRA) .
Receives: Procedure: Standardized post-operative analgesia protocol

What is being measured

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

  1. FQoR-15 score at 24 hours (French Quality of Recovery-15 score)

    Value of the French Quality of Recovery-15 score (minimum value of 0 and maximum value of 150, with a higher score for a better outcome).

    The QoR-15 questionnaires will be completed by the patient himself whenever possible, who could be helped by a nurse blinded to the assignment group.

    Measured: 24 hours after surgery

Secondary outcomes (12)

  1. Pain (VRS) at rest and mobilisation

    Analgesic efficacy at rest and during exercise (cough, physiotherapy session, mobilization) assessed via pain measurements by a simple verbal rating scale (VRS) with 11 items (0: no pain, 10: maximum pain)

    Measured: 3, 6, 12, 24, 48 , 72 hours after surgery and during the removal of surgical drains

  2. Post-operative consumption of morphine (milligrams)

    Amount of opioid consumption, in equivalent of milligrams.

    Measured: 3, 6, 12 hours after surgery and daily assessed at 24, 48, 72, 96 and 120 hours after surgery

  3. Post-operative consumption of daily non-morphine analgesics (milligrams)

    Including Pacetamol, Nefopam, ketoprofene, Ketamine in milligrams.

    Measured: 24, 48, 72, 96 and 120 hours after surgery

  4. Rate of painful patients

    Proportion of patients having had at least one VRS >3

    Measured: 24 and 48 hours after surgery

  5. FQoR-15 score at 48 hours

    The quality of postoperative recovery reassessed 48 hours after surgery by the FQoR-15; Value of the French Quality of Recovery-15 score (minimum value of 0 and maximum value of 150, with a higher score for a better outcome).

    The QoR-15 questionnaires will be completed by the patient himself whenever possible, who could be helped by a nurse blinded to the assignment group.

    Measured: 48 hours after surgery

  6. Rate of patients with at least one complication of LRA

    Proportion of patients with at least one complication of LRA: systemic intoxication with local anesthetics within 3 hours after injection, hematoma or infection at the puncture site.

    Measured: 30 days

  7. Rate of postoperative complications

    The proportion of patients with at least one major postoperative complication of cardiac surgery during hospitalization: de novo postoperative atrial fibrillation, revision surgery, respiratory failure, mediastinitis, neurological complication, acute renal failure, gastrointestinal complication, infectious complication with bacteremia, pneumothorax, infectious pneumonitis.

    Measured: 30 days

  8. Rate of patients return to preoperative weight

    Proportion of patient return to announced weight at the pre-anaesthetic consultation (truncating the weight in kg)

    Measured: Noted at day 3 and 5 after surgery

  9. Rate of patients return to a transit

    Proportion of patient return to a transit (including solid or gaseous transit)

    Measured: Noted at day 3 and 5 after surgery

  10. Extubation time (hours)

    Measured in number of hours since arrival in intensive care (between arrival in intensive care and the first attempt at extubation);

    Measured: Noted at Day 30

  11. Duration of hospitalization. (days)

    The length of stay in post-operative intensive care (between arrival in intensive care and leaving the service) and in the hospital counted in number of days started.

    Measured: Noted at Day 30

  12. Rate of readmission to intensive care.

    The proportion of patients admitted in the intensive care unit whatever the reason, censored at 30 days.

    Measured: Noted at Day 30

Timeline

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

  1. First posted26 Apr 2022
  2. Study start1 Aug 2022
  3. Primary completion8 Aug 2023
  4. Study completion7 Sep 2023

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study phase III, superiority study, monocentric, comparative, with three parallel groups, randomized with a ratio (1:1:1), controlled versus standard care, single-blind
Masking
Single blind
Who is masked
Participant
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05345639
Sponsor's protocol ID
49RC21_0251
Acronym
PABLOS
Status last verified
Dec 2024
First submitted
12 Apr 2022
Last updated
21 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data will be collected in a coded manner: 1st letter of the surname, 1st letter of the patient's first name, serial number of inclusion in the center by the physicians investigating the study in the electronic observation notebook of the study ( EnnovClinical) managed by the DRCI of the CHU of Angers.

Publications

  • Bignami E, Castella A, Pota V, Saglietti F, Scognamiglio A, Trumello C, Pace MC, Allegri M. Perioperative pain management in cardiac surgery: a systematic review. Minerva Anestesiol. 2018 Apr;84(4):488-503. doi: 10.23736/S0375-9393.17.12142-5. Epub 2017 Oct 12.

    PubMed 29027773

  • Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.

    PubMed 17006079

  • Huang AP, Sakata RK. Pain after sternotomy - review. Braz J Anesthesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjane.2014.09.013. Epub 2016 Apr 23.

    PubMed 27343790

  • McIsaac DI, Cole ET, McCartney CJ. Impact of including regional anaesthesia in enhanced recovery protocols: a scoping review. Br J Anaesth. 2015 Dec;115 Suppl 2:ii46-56. doi: 10.1093/bja/aev376.

    PubMed 26658201

  • Ueshima H, Hara E, Marui T, Otake H. RETRACTED: The ultrasound-guided transversus thoracic muscle plane block is effective for the median sternotomy. J Clin Anesth. 2016 Mar;29:83. doi: 10.1016/j.jclinane.2015.10.014. Epub 2016 Feb 9. No abstract available.

    PubMed 26897453

  • de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. No abstract available.

    PubMed 24396082

  • Leger M, Campfort M, Cayla C, Parot-Schinkel E, Lasocki S, Rineau E. Validation of an alternative French version of the Quality of Recovery-15 Score: the FQoR-15. Br J Anaesth. 2020 Oct;125(4):e345-e347. doi: 10.1016/j.bja.2020.05.052. Epub 2020 Jul 9. No abstract available.

    PubMed 32654751

  • Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.

    PubMed 29397134

  • Myles PS, Boney O, Botti M, Cyna AM, Gan TJ, Jensen MP, Kehlet H, Kurz A, De Oliveira GS Jr, Peyton P, Sessler DI, Tramer MR, Wu CL; StEP-COMPAC Group; Myles P, Grocott M, Biccard B, Blazeby J, Boney O, Chan M, Diouf E, Fleisher L, Kalkman C, Kurz A, Moonesinghe R, Wijeysundera D. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort. Br J Anaesth. 2018 Apr;120(4):705-711. doi: 10.1016/j.bja.2017.12.037. Epub 2018 Feb 2.

    PubMed 29576111

  • Demarquette A, Jeanneteau A, Blanchard-Daguet A, Fouquet O, Parot-Schinkel E, Lasocki S, Rineau E, Leger M. Impact of superficial and deep parasternal blocks on recovery after cardiac surgery with sternotomy: a randomised controlled trial. Br J Anaesth. 2025 Sep;135(3):764-771. doi: 10.1016/j.bja.2025.05.043. Epub 2025 Jul 9.

    PubMed 40640047

  • Jeanneteau A, Demarquette A, Blanchard-Daguet A, Fouquet O, Lasocki S, Riou J, Rineau E, Leger M. Effect of superficial and deep parasternal blocks on recovery after cardiac surgery: study protocol for a randomized controlled trial. Trials. 2023 Jul 6;24(1):444. doi: 10.1186/s13063-023-07446-2.

    PubMed 37415221

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LRA Loco-regional anesthesia and Standardized post-operative analgesia protocol in people with Pain, Postoperative and Cardiac Surgery, run by University Hospital, Angers at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 21 Mar 2025. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

FQoR-15 score at 24 hours (French Quality of Recovery-15 score) (time frame: 24 hours after 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 NCT05345639, which also lists 11 linked publications.

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 21 Mar 2025.

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