Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases (NCT02851186) | Clinical Trial Compass
CompletedNot Applicable
Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases
Hong Kong72 participantsStarted 2016-10-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under the curve of Pain intensity by numerical rating scale (NRS) from baseline to day 5