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

NCT05345639 | Completed Phase 3 DMC

• 1 other identifier: 49RC21_0251
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pain, Postoperative; Cardiac Surgery

Keywords

LRA; Block; ERAS; FQOR-15; QOR-15; Transversus thoracic block; Parasternal block; Cardiac surgery; Analgesia; PIP (parasternal intercostal plane block); Régional anesthesia

Outcome Measures

Primary Outcomes (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.

  24 hours after surgery

Secondary Outcomes (12)

• Pain (VRS) at rest and mobilisation

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

• Post-operative consumption of morphine (milligrams)

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

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

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

• Rate of painful patients

  24 and 48 hours after surgery

• FQoR-15 score at 48 hours

  48 hours after surgery

Study Arms (3)

TTP group (= Transversus Thoracic Plane block = Deep PIP = Deep parasternal intercostal plane block)

EXPERIMENTAL

At the end of the surgery, realisation of a bilateral transverse thoracic block. (20ml of Naropeine 0.2%, each side) Followed by standard analgesic treatment.

Drug: LRA Loco-regional anesthesia; Procedure: Standardized post-operative analgesia protocol

PSB group (=ParaSternal Block = Superficial PIP = Superficial parasternal intercostal plane block)

EXPERIMENTAL

At the end of the surgery, realisation of a bilateral parasternal block (20ml of Naropeine 0.2%, each side). Followed by standard analgesic treatment.

Drug: LRA Loco-regional anesthesia; Procedure: Standardized post-operative analgesia protocol

Control group

SHAM COMPARATOR

Standard analgesic treatment alone (without LRA) .

Procedure: Standardized post-operative analgesia protocol

Interventions

LRA Loco-regional anesthesia DRUG

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.

Also known as: 40ml Ropivacaine 0.2%

PSB group (=ParaSternal Block = Superficial PIP = Superficial parasternal intercostal plane block); TTP group (= Transversus Thoracic Plane block = Deep PIP = Deep parasternal intercostal plane block)

Standardized post-operative analgesia protocol PROCEDURE

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.

Control group; PSB group (=ParaSternal Block = Superficial PIP = Superficial parasternal intercostal plane block); TTP group (= Transversus Thoracic Plane block = Deep PIP = Deep parasternal intercostal plane block)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead
• Fondation Apicil: collaborator

Study Sites (1)

Jeanneteau

Angers, maine et loire, 49933, France

Location

Related Publications (11)

• 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.

  PMID: 29027773 BACKGROUND

• 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.

  PMID: 17006079 BACKGROUND

• 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.

  PMID: 27343790 BACKGROUND

• 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.

  PMID: 26658201 BACKGROUND

• 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.

  PMID: 26897453 BACKGROUND

• 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.

  PMID: 24396082 BACKGROUND

• 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.

  PMID: 32654751 BACKGROUND

• 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.

  PMID: 29397134 BACKGROUND

• 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.

  PMID: 29576111 BACKGROUND

• 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.

  PMID: 40640047 DERIVED

• 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.

  PMID: 37415221 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Bites and Stings; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization takes place during surgery. Bilateral parasternal block or transverse thoracic block are performed ultrasound-guided, under general anesthesia.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Study phase III, superiority study, monocentric, comparative, with three parallel groups, randomized with a ratio (1:1:1), controlled versus standard care, single-blind

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 26, 2022
• Study Start: August 1, 2022
• Primary Completion: August 8, 2023
• Study Completion: September 7, 2023
• Last Updated: March 21, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)