Chest Wall Block After Sternotomy: Randomized Controlled Trial in Cardiac Surgery: (PABLOS Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- FQoR-15 score at 24 hours (French Quality of Recovery-15 score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Randomization takes place during surgery. Bilateral parasternal block or transverse thoracic block are performed ultrasound-guided, under general anesthesia.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TTP group (= Transversus Thoracic Plane block = Deep PIP = Deep parasternal intercostal plane block)
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.
干预措施: LRA Loco-regional anesthesia (Drug)
TTP group (= Transversus Thoracic Plane block = Deep PIP = Deep parasternal intercostal plane block)
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.
干预措施: Standardized post-operative analgesia protocol (Procedure)
PSB group (=ParaSternal Block = Superficial PIP = Superficial parasternal intercostal plane block)
At the end of the surgery, realisation of a bilateral parasternal block (20ml of Naropeine 0.2%, each side).
Followed by standard analgesic treatment.
干预措施: LRA Loco-regional anesthesia (Drug)
PSB group (=ParaSternal Block = Superficial PIP = Superficial parasternal intercostal plane block)
At the end of the surgery, realisation of a bilateral parasternal block (20ml of Naropeine 0.2%, each side).
Followed by standard analgesic treatment.
干预措施: Standardized post-operative analgesia protocol (Procedure)
Control group
Standard analgesic treatment alone (without LRA) .
干预措施: Standardized post-operative analgesia protocol (Procedure)
结局指标
主要结局
FQoR-15 score at 24 hours (French Quality of Recovery-15 score)
时间窗: 24 hours after surgery
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.
次要结局
- Rate of painful patients(24 and 48 hours after surgery)
- 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 daily non-morphine analgesics (milligrams)(24, 48, 72, 96 and 120 hours after surgery)
- Duration of hospitalization. (days)(Noted at Day 30)
- 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)
- Extubation time (hours)(Noted at Day 30)
- FQoR-15 score at 48 hours(48 hours after surgery)
- Rate of patients return to preoperative weight(Noted at day 3 and 5 after surgery)
- Rate of patients return to a transit(Noted at day 3 and 5 after surgery)
- Rate of readmission to intensive care.(Noted at Day 30)
- Rate of postoperative complications(30 days)
- Rate of patients with at least one complication of LRA(30 days)