Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: Acupuncture; Device: Sham acupuncture

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Kwong Wah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Number of patients withdraw	Through study completion, an average of 7 days
Reasons of withdrawal	Through study completion, an average of 7 days
Number of subjects with adverse events	Through study completion, an average of 7 days
Treatment Credibility by the Credibility of Treatment Rating Scale (CTRS)	Through study completion, an average of 7 days
Blinding Success Assessment by questionnaire	Day 5

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Lixing Lao, The University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimate): August 1, 2016

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: UW 15-459