Clinical trial NCT02851186: Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases
Official title: Combined Electroacupuncture and Auricular Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases: A Randomized Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Primary outcomes:
measure: Area under the curve of Pain intensity by numerical rating scale (NRS) from baseline to day 5
timeFrame: 5 days
Secondary outcomes:
measure: Pain intensity by numerical rating scale (NRS) at rest
timeFrame: Through study completion, an average of 7 days
measure: Pain intensity by numerical rating scale (NRS) while coughing
timeFrame: Through study completion, an average of 7 days
measure: Cumulative morphine consumption
timeFrame: Through study completion, an average of 7 days
measure: Dose of rescues analgesic (IM morphine) use
timeFrame: Through study completion, an average of 7 days
measure: Frequency of rescues analgesic (IM morphine) use
timeFrame: Through study completion, an average of 7 days
measure: Time of recovery from postoperative syndrome
timeFrame: Through study completion, an average of 7 days
measure: Quality of recovery (QoR-9)
timeFrame: Through study completion, an average of 7 days
measure: SF-6D
timeFrame: Through study completion, an average of 7 days
measure: EQ-5D-5L
timeFrame: Through study completion, an average of 7 days
Other outcomes:
measure: Number of patients withdraw
timeFrame: Through study completion, an average of 7 days
measure: Reasons of withdrawal
timeFrame: Through study completion, an average of 7 days
measure: Number of subjects with adverse events
timeFrame: Through study completion, an average of 7 days
measure: Treatment Credibility by the Credibility of Treatment Rating Scale (CTRS)
timeFrame: Through study completion, an average of 7 days
measure: Blinding Success Assessment by questionnaire
timeFrame: Day 5
Locations:
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Lixing LAO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lam WL, Yeung WF, Wong MK, Cheung CW, Chan KKL, Ngan HYS, Wong CKH, Chen HY, Lao L. Combined electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynecological diseases: study protocol for a randomized controlled trial. Trials. 2018 Jan 4;19(1):8. doi: 10.1186/s13063-017-2359-8.