Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management in Women Undergoing Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Post-operative Pain Score
研究概览
简要总结
This is a pilot randomized controlled trial examining post-operative pain scores and outcomes after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to routine post-operative multi-modal analgesia, compared to those patients prescribed routine multi-modal analgesia without cold therapy. All patients scheduled for total laparoscopic hysterectomy (without robotic-assistance) will be screened for eligibility in the study. If eligible, patients will be invited to participate in the study and standardized informed consent process will ensue. After surgery is completed participants will be randomized to either the control group or the study group. The study group will be prescribed the use of cold therapy to their abdominal incisions through reusable cold gel packs. The cold therapy is to be applied to participants' incisions for the first three postoperative days, in addition to routine post-operative analgesia regimen. Investigators will then collect information on pain scores, narcotic use, quality of life and surgical recovery scores.
This study aims to examine if there is a difference in post-operative pain scores with the application of cold therapy to laparoscopic abdominal incisions following laparoscopic hysterectomy, when compared to no cold therapy. Secondarily, investigators will examine post-operative quality of life scores, postoperative surgical recovery scores, as well as narcotic use among the two groups. Investigators also aim to ascertain additional information regarding total quantity of narcotics used post-operatively to aid in prescribing patterns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Patients can understand and voluntarily sign an informed consent form
- •Female gender ages 18-65
- •Scheduled for laparoscopic hysterectomy for benign indications, total or subtotal, without or without oophorectomy (standard of care involves bilateral salpingectomy)
排除标准
- •Conversion to laparotomy
- •Diagnosis of chronic pelvic pain
- •No access to freezer at home to keep reusable cold packs cold between uses
- •Contraindications to exposure to cold therapy (history of cold allergy, cold intolerance, Raynaud's disease, cold urticaria, cryoglobulinemia, or pyoderma gangrenosum)
- •Medical contraindication to NSAID use
研究组 & 干预措施
Cold Therapy
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours.
干预措施: Cold therapy via reusable cold gel pack (Device)
Control
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention.
结局指标
主要结局
Post-operative Pain Score
时间窗: 24 hours post-operatively following total laparoscopic hysterectomy
Post-operative pain score on an 11 point numeric rating scale, minimum value of 0 and maximum value of 10, zero meaning no pain and 10 meaning the worst pain imaginable.
次要结局
- Post-operative Pain Score(72 hours post-operatively following total laparoscopic hysterectomy)
- Patient Reported Quantity of Narcotics Used Post-operatively(72 hours post-operatively following total laparoscopic hysterectomy)
- Quality of Life Score as Measured by the Validated Abdominal Surgery Impact Scale(72 hours post-operatively following total laparoscopic hysterectomy)
- Surgical Recovery Score as Measured by the Validated Surgical Recovery Scale(10-14 days post-operatively following total laparoscopic hysterectomy)
研究者
Pamela Frazzini Padilla
Clinical Fellow
Cleveland Clinic Florida