Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases

Study Overview
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Brief Summary
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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.

Official Title
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Combined Electroacupuncture and Auricular Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases: A Randomized Sham-controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Device: Acupuncture
* Device: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture (EA) and Auricular Acupuncture (AA)<br>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. | Device: Acupuncture<br> <br> |
| Sham Comparator: Sham acupuncture<br>Subjects in the control group will receive non-invasive sham procedure in the same schedule as the treatment group. | Device: Sham acupuncture<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of Pain intensity by numerical rating scale (NRS) from baseline to day 5 |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| SF-6D |  | Through study completion, an average of 7 days | 
| EQ-5D-5L |  | Through study completion, an average of 7 days |