Evaluation of the Effect of Lidocaine With Adrenaline, With or Without Bicarbonate, on Early Postoperative Recovery in WALLANT-type Outpatient Hand and Foot Surgery: A Prospective, Randomised, Double-blind, Single-centre Non-inferiority Study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- QoR-15 score, assessed at 24 hours postoperatively in both study arms
研究概览
简要总结
Distal upper limb and distal lower limb surgery performed under local anesthesia using the WALANT technique (Wide Awake Local Anesthesia No Tourniquet) has become standard practice in ambulatory orthopedic surgery. Current infiltration mixtures used by orthopedic surgeons include lidocaine-epinephrine with the addition of 8.4% bicarbonate to reduce injection-related pain and improve analgesia duration. However, the clinical benefit of bicarbonate addition remains insufficiently supported by evidence and may increase preparation complexity and risk, including potential solution crystallization.
The aim of the ROPIWA-2 trial is to investigate whether omission of bicarbonate from the local infiltration mixture is noninferior to bicarbonate addition with respect to early postoperative quality of recovery on postoperative day 1. We hypothesize that removing bicarbonate does not impair postoperative quality of recovery after ambulatory hand and foot surgery under WALANT. Expected benefits include confirmation of a simpler, ready-to-use anesthetic solution that is easier and safer to use, without reducing patient comfort or recovery. The expected risks are those normally associated with this type of procedure.
详细描述
Study context WALANT (Wide Awake Local Anesthesia No Tourniquet) is increasingly used for ambulatory hand and foot surgery, as it allows surgery without preoperative fasting and provides effective local anesthesia without a tourniquet, while promoting early functional recovery.
Sodium bicarbonate is commonly added to lidocaine-epinephrine solutions to reduce injection-related pain and prolong the duration of the anesthetic block. However, its clinical benefit remains uncertain and may increase preparation complexity.
Therefore, a robust methodological assessment of the impact of bicarbonate omission on early postoperative recovery is warranted in ambulatory WALANT surgery.
Primary objective To evaluate the effect of two WALANT local anesthesia protocols (lidocaine-epinephrine with or without bicarbonate addition) on early postoperative recovery at 24 hours after ambulatory hand and foot surgery.
Key secondary objectives A) Sensory block onset time. B) Intraoperative anesthetic block failure rate. C) Pain related to injection of the WALANT anesthetic solution. D) Intraoperative pain intensity. E) Patient satisfaction with perioperative care. F) Postoperative pain scores. G) Postoperative analgesic consumption, including opioids. H) Duration of the anesthetic block I) Postoperative adverse events.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be blinded to the WALANT local infiltration solution administered.
Investigators performing the local anesthesia and the surgical procedure, as well as outcome assessors (investigator-delegated evaluators, hospital clinical research associates, and evaluating physicians), will also be blinded to treatment allocation. Preoperative and postoperative assessments will be performed by providers different from those who performed the procedure.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) eligible for ambulatory surgery under WALANT for Hand surgery (including carpal tunnel release, trigger finger release, or Dupuytren's disease surgery) and foot surgery (including hallux valgus or hallux rigidus.)
- •Provision of free and informed consent.
- •Signed informed consent form.
- •Affiliation with or beneficiary of a health insurance system
排除标准
- •Ischemic vascular disorders, including severe Raynaud's disease, Buerger's disease, or diabetic microangiopathy.
- •Scleroderma.
- •Known allergy to lidocaine or potential cross-reactivity with other amide-type local anesthetics.
- •Severe hepatic impairment.
- •Acute porphyria.
- •Intravascular administration of local anesthesia.
- •Local anesthetic infiltration at the level of the extremities.
- •Coronary artery disease.
- •Ventricular arrhythmias.
- •Severe arterial hypertension.
- •Obstructive cardiomyopathy.
- •Hyperthyroidism.
- •Hypovolemia.
- •Participation in an interventional clinical research study classified as category 1 (RIPH category 1).
- •Ongoing exclusion period related to participation in another clinical study.
- •Legal protection status (guardianship, trusteeship, or judicial protection).
- •Inability to provide informed consent.
- •Inability to receive or understand adequate study information.
- •Pregnancy, labor, or breastfeeding. Women of childbearing potential will undergo a urine pregnancy test prior to inclusion.
结局指标
主要结局
QoR-15 score, assessed at 24 hours postoperatively in both study arms
时间窗: 24 hours after surgery
QoR-15 score, assessed at 24 hours postoperatively in both study arms. This validated questionnaire includes 15 items covering five dimensions: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is rated on a 1-10 scale, with a total score ranging from 15 to 150.
次要结局
- Sensory block onset time(Day 0)
- Intraoperative anesthetic block failure rate(Day0)
- Pain related to injection of the WALANT anesthetic solution.(Day 0)
- Intraoperative pain intensity(Day 0)
- Patient satisfaction with perioperative care(Day 0)
- Postoperative pain scores(Day 2)
- Postoperative analgesic consumption, including opioids(Day 2)
- Duration of the anesthetic block(Day 1)
- Postoperative adverse events(Day 2)