Last updated on February 2018

Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases


Brief description of study

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.

Clinical Study Identifier: NCT02851186

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