Integrating Acupuncture Into Postoperative Pain Management in Patients Undergoing Open Abdominal Operations
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Compliance
研究概览
简要总结
This trial investigates how well acupuncture works for the management of pain after surgery in patients having open colorectal or pancreatic surgery. Acupuncture may help to reduce postoperative symptoms including pain. This study may help researchers learn if acupuncture reduces after-surgery side effects and improves recovery.
详细描述
PRIMARY OBJECTIVE:
I. Determine the feasibility of providing postoperative acupuncture for patients undergoing open colorectal or pancreatic surgery.
SECONDARY OBJECTIVE:
I. Compare postoperative opioid use for pain management, pain levels, and satisfaction of pain control between acupuncture and standard care groups.
EXPLORATORY OBJECTIVE:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing open gastrointestinal cancer resection (pancreatic or colorectal)
- •Must understand and read English
- •Sign a written informed consent and willing to follow protocol requirements
- •Able to consent to treatment
排除标准
- •Chronic opioid use > 90 mg MME (morphine milligram equivalents) for more than 7 days
- •Mechanical bowel obstruction
- •Active seizure activity after admission
- •Compromised cognitive function per referring physician and/or inability to cooperate with acupuncture procedure
- •Direct admission to intensive care unit after operation will result in removal from protocol
- •Prior intra-abdominal operation in the past 6 months
- •Any contraindications to acupuncture including infections or inability to access acupoint sites
研究组 & 干预措施
Arm I (acupuncture, usual care)
Beginning the day after surgery, patients undergo acupuncture sessions over 25 minutes QD for up to 7 days. Patients also undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
干预措施: Acupuncture Therapy (Procedure)
Arm I (acupuncture, usual care)
Beginning the day after surgery, patients undergo acupuncture sessions over 25 minutes QD for up to 7 days. Patients also undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
干预措施: Best Practice (Other)
Arm I (acupuncture, usual care)
Beginning the day after surgery, patients undergo acupuncture sessions over 25 minutes QD for up to 7 days. Patients also undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
干预措施: Questionnaire Administration (Other)
Arm II (usual care)
Patients undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
干预措施: Questionnaire Administration (Other)
Arm II (usual care)
Patients undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
干预措施: Best Practice (Other)
结局指标
主要结局
Compliance
时间窗: Up to 7 days
Acupuncturist and research coordinator will document in EPIC if participant is compliant with acupuncture sessions (study intervention) and with study questionnaires.
Retention
时间窗: Up to 7 days
Will be measured as percentage of patients who complete the study out of the number of patients after study randomization.
Adherence rate to daily acupuncture
时间窗: Up to 7 days
Acupuncturist will document in the medical record all the treatments participants are completing and also document if missing any treatments.
次要结局
- Satisfaction of pain control(Up to 7 days)
- Pain levels(Up to 7 days)
- Postoperative opioid use for pain management(24 hours)