Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851186
• Other study ID #: UW 15-459
• Status: Completed
• Phase: N/A
• Start date: October 12, 2016
• Est. completion date: November 2018

Study information

• Verified date: September 2019
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• Acupuncture

• Sham acupuncture

Locations

Country	Name	City	State
Hong Kong	Kwong Wah Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients withdraw		Through study completion, an average of 7 days
Other	Reasons of withdrawal		Through study completion, an average of 7 days
Other	Number of subjects with adverse events		Through study completion, an average of 7 days
Other	Treatment Credibility by the Credibility of Treatment Rating Scale (CTRS)		Through study completion, an average of 7 days
Other	Blinding Success Assessment by questionnaire		Day 5
Primary	Area under the curve of Pain intensity by numerical rating scale (NRS) from baseline to day 5		5 days
Secondary	Pain intensity by numerical rating scale (NRS) at rest		Through study completion, an average of 7 days
Secondary	Pain intensity by numerical rating scale (NRS) while coughing		Through study completion, an average of 7 days
Secondary	Cumulative morphine consumption		Through study completion, an average of 7 days
Secondary	Dose of rescues analgesic (IM morphine) use		Through study completion, an average of 7 days
Secondary	Frequency of rescues analgesic (IM morphine) use		Through study completion, an average of 7 days
Secondary	Time of recovery from postoperative syndrome		Through study completion, an average of 7 days
Secondary	Quality of recovery (QoR-9)		Through study completion, an average of 7 days
Secondary	SF-6D		Through study completion, an average of 7 days
Secondary	EQ-5D-5L		Through study completion, an average of 7 days