Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases

NCT02851186 | Completed DMC

• 1 other identifier: UW 15-459
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Area under the curve of Pain intensity by numerical rating scale (NRS) from baseline to day 5

  5 days

Secondary Outcomes (9)

• 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

Other Outcomes (5)

• 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

Study Arms (2)

Electroacupuncture (EA) and Auricular Acupuncture (AA)

EXPERIMENTAL

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 acupuncture

SHAM COMPARATOR

Subjects in the control group will receive non-invasive sham procedure in the same schedule as the treatment group.

Device: Sham acupuncture

Interventions

Acupuncture DEVICE

Electroacupuncture (EA) and Auricular Acupuncture (AA)

Sham acupuncture DEVICE

Sham acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Kwong Wah Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 29301556 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Lixing LAO

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: August 1, 2016
• Study Start: October 12, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

HK (2)