Combined Electroacupuncture and Auricular Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases: A Randomized Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Area under the curve of Pain intensity by numerical rating scale (NRS) from baseline to day 5
研究概览
简要总结
Objectives:
To examine the efficacy and safety of electroacupuncture (EA) combined with auricular acupuncture (AA) in reducing post-operative pain in patients following abdominal surgery for gynecological diseases.
Hypothesis:
Acupuncture is effective and safe to reduce postoperative pain during the first 5 days following surgery as compared to a sham control.
Design and strategy:
This is a randomized, placebo-controlled, subject- and assessor-blind trial. Seventy-two subjects will be recruited and randomized (in 1:1 ratio) to receive either acupuncture treatment or sham control. Subjects in both groups will undergo standard operation procedure and receive post-operative analgesics based on usual care.
Study instrument:
A 10-point pain Numerical Rating Scale (NRS) will be employed as a primary outcome assessment.
Intervention:
Subjects in the treatment group will receive EA combined with AA within two hours before operation, post-operation upon arrival to the ward and once a day for the subsequent 5 days. Subjects in the control group will receive non-invasive sham procedure in the same schedule.
Main outcome measures:
Primary outcome: NRS pain scores will be measured upon recovery, hourly at 6 hours after surgery, then 4-hourly until day 2, 6-hourly until day 3 and once daily until discharge.
Secondary outcome:
Morphine consumption, post-operative syndromes, quality of recovery questionnaire, SF-6D, EQ-5D-5L and adverse events will be documented and compared between groups.
Data analysis: Pain intensity during the first 5 days will be calculated by Area Under the Curve (AUC) of NRS pain scores. AUC between the two groups will be compared by Student's T-test.
Expected outcome: AUC of the acupuncture group is expected to be significantly lower than sham acupuncture group.
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
- Double (Participant, Outcomes Assessor)
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
- •American Society of Anesthesiologists (ASA) physical status I to III
- •Eligible for laparotomy with midline incision for gynaecological neoplasm including ovarian mass, uterine mass and cervical lesions
- •Age 18 years or above
- •Ability to understand the nature of the study and willing to give informed consent
- •Capable of providing responses during outcome measurement
排除标准
- •Having chronic pain and using any medication in addition to the anaesthetic and analgesia prescribed prior to surgery that would be expected to affect the dosage of postoperative analgesia
- •History of or current alcohol or drug abuse
- •Impaired renal function, defined as preoperative serum creatinine level over 120µmol/L
- •Impaired hepatic function, defined as preoperative serum albumin level below 30g/L
- •Impaired or retarded mental state and not able to sign the consent
- •Not self-ambulatory before operation
- •Difficulties in using patient-controlled analgesia
- •BMI > 35kg/m2
- •Infection observed at the acupoint sites
- •History of acupuncture experience in the previous 12 months
- •History or clinical evidence of valvular heart defects, heart failure, atrial fibrillation or bleeding disorders or are fitted with cardiac pacemaker or taking anticoagulant drugs
研究组 & 干预措施
Electroacupuncture (EA) and Auricular Acupuncture (AA)
Subjects in the treatment group will receive EA combined with AA two hours before operation, immediately post-operation and once a day for the subsequent 5 days.
干预措施: Acupuncture (Device)
Sham acupuncture
Subjects in the control group will receive non-invasive sham procedure in the same schedule as the treatment group.
干预措施: Sham acupuncture (Device)
结局指标
主要结局
Area under the curve of Pain intensity by numerical rating scale (NRS) from baseline to day 5
时间窗: 5 days
次要结局
- Time of recovery from postoperative syndrome(Through study completion, an average of 7 days)
- Quality of recovery (QoR-9)(Through study completion, an average of 7 days)
- Pain intensity by numerical rating scale (NRS) at rest(Through study completion, an average of 7 days)
- Pain intensity by numerical rating scale (NRS) while coughing(Through study completion, an average of 7 days)
- Cumulative morphine consumption(Through study completion, an average of 7 days)
- Dose of rescues analgesic (IM morphine) use(Through study completion, an average of 7 days)
- Frequency of rescues analgesic (IM morphine) use(Through study completion, an average of 7 days)
- SF-6D(Through study completion, an average of 7 days)
- EQ-5D-5L(Through study completion, an average of 7 days)