Benefit of Acupuncture Combined to Regional Analgesia for Post Operative Pain Relief After Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- quality of pain relief
研究概览
简要总结
Since the 90's, the quality of the post operative pain relief is a main concern in most of the healthcare systems in the world. An efficient pain relief improves the quality of recovery after surgery [Level 1A], reduces the risk of persistent pain [level 1A] and makes the patients satisfied.
Continuous regional anesthesia/analgesia promotes a level 1A in quality of postoperative pain relief, reduction in opioids consumption in opioid sparing/free analgesia programs, time to recover and the reduction of hospital stay. However in the postoperative period, breakthrough pain episodes due to mobilization or activity are not well covered by regional analgesia. Furthermore, after removal of the catheter of regional anesthesia, patients may face an unpleasant rebound pain effect.
At VinMec, the technique of regional anesthesia chosen to provide regional analgesia after hysterectomy is a bilateral erector spinae plane block .
Traditional Medicine relieves pain by non-pharmacological methods, especially by acupuncture which bring positive results. Acupuncture has been proven to provide pain relief according to the mechanism of traditional and modern medicine, safe for patients and with few side effects. The acupunture point formula is used by VinMec Sao Phuong Dong Traditional Medicine Center in conjunction with the department of Anesthesiology and Pain management in VinMec Times City International General Hospital to relieve pain after hysterectomy including: Three Yin Intersection (SP-6), Leg Three Miles (ST-36), Taichong (LR-3), Xuehai (SP-10).
The study is to observe the effect of combining acupuncture with regional anesthesia on pain relief and postoperative recovery in patients undergoing hysterectomy.
There is no published study regarding the effects of combining the 2 techniques above as multimodal approach for post operative analgesia after hysterectomy.
详细描述
Design A single center, open label, prospective randomized controlled trial to study the benefits of combining acupuncture with bilateral continuous ESPB compared to bilateral ESPB alone in patients scheduled for an hysterectomy .
Patient selection At the pre-anesthetic consultation or performed at least 24h before the surgery.
Enrollment and allocation During the pre-anesthetic consultation, if the patient accepts the proven benefits to have surgery performed under combined general anesthesia and regional anesthesia, the anesthesiologist will offer her to participate in the study comparing these two bundles of care using regional anesthesia.
Patients will be assigned via a random number generator into one of two study groups (1 Or 2) by the physician/nurse who obtained consent which is prescribed in the nurse preparation file.
Surgical technique Elective hysterectomy by laparoscopic or Pfannenstiel incision
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •elective hysterectomy
- •accept ton participate
- •signed consent
排除标准
- •patient refusal
- •allergy to local anesthetics
- •complex congenital malformation
- •mental deficit
- •substance abuse(alcohol, drugs, opioids)
- •renal insufficiency
结局指标
主要结局
quality of pain relief
时间窗: from end of surgery to 3rd day after the surgery
the area under the curves the Visual analgesia Scores for pain at rest and pain at mobilization
次要结局
- Opioid consumption(from end of surgery to 3rd day after the surgery)
- Quality of recovery(measured on 4th day after surgery)