NCT05345639

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative
• Cardiac Surgery

Interventions

Type	Name	Description
DRUG	LRA Loco-regional anesthesia	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.
PROCEDURE	Standardized post-operative analgesia protocol	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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-08
• Completion: 2023-09-07
• First posted: 2022-04-26
• Last updated: 2025-03-21

Locations

1 site across 1 country: France