Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases

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.