acupuncture for postoperative pain after abdominal surgery for gynecological diseases

Conditions: Postoperative Pain

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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