Combined Electroacupuncture and Auricular Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases: A Randomized Sham-controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Pain
- Sponsor
- The University of Hong Kong
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Area under the curve of Pain intensity by numerical rating scale (NRS) from baseline to day 5
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Area under the curve of Pain intensity by numerical rating scale (NRS) from baseline to day 5
Time Frame: 5 days
Secondary Outcomes
- 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)
- 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)
- SF-6D(Through study completion, an average of 7 days)
- EQ-5D-5L(Through study completion, an average of 7 days)