Clinical trial NCT05345639: Chest Wall Block After Sternotomy: Randomized Controlled Trial in Cardiac Surgery: (PABLOS Study)
Official title: Chest Wall Block After Sternotomy: Randomized Controlled Trial in Cardiac Surgery: (PABLOS Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Fondation Apicil
First posted: 2022-04-26
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: FQoR-15 score at 24 hours (French Quality of Recovery-15 score)
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Pain (VRS) at rest and mobilisation
timeFrame: 3, 6, 12, 24, 48 , 72 hours after surgery and during the removal of surgical drains
measure: Post-operative consumption of morphine (milligrams)
timeFrame: 3, 6, 12 hours after surgery and daily assessed at 24, 48, 72, 96 and 120 hours after surgery
measure: Post-operative consumption of daily non-morphine analgesics (milligrams)
timeFrame: 24, 48, 72, 96 and 120 hours after surgery
measure: Rate of painful patients
timeFrame: 24 and 48 hours after surgery
measure: FQoR-15 score at 48 hours
timeFrame: 48 hours after surgery
measure: Rate of patients with at least one complication of LRA
timeFrame: 30 days
measure: Rate of postoperative complications
timeFrame: 30 days
measure: Rate of patients return to preoperative weight
timeFrame: Noted at day 3 and 5 after surgery
measure: Rate of patients return to a transit
timeFrame: Noted at day 3 and 5 after surgery
measure: Extubation time (hours)
timeFrame: Noted at Day 30
measure: Duration of hospitalization. (days)
timeFrame: Noted at Day 30
measure: Rate of readmission to intensive care.
timeFrame: Noted at Day 30
Other outcomes:
Locations:
city: Angers
country: France
facility: Jeanneteau
state: Maine Et Loire
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.