Postoperative PainNCT02851186
Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases
A study testing Acupuncture in people with Postoperative Pain, run by The University of Hong Kong at 2 sites in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesHong Kong
- Study dates
- 12 Oct 2016to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Acupuncture, Sham acupuncture
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Sham acupunctureDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of Pain intensity by numerical rating scale (NRS) from baseline to day 5
Measured: 5 days
Secondary outcomes (9)
Pain intensity by numerical rating scale (NRS) at rest
Measured: Through study completion, an average of 7 days
Pain intensity by numerical rating scale (NRS) while coughing
Measured: Through study completion, an average of 7 days
Cumulative morphine consumption
Measured: Through study completion, an average of 7 days
Dose of rescues analgesic (IM morphine) use
Measured: Through study completion, an average of 7 days
Frequency of rescues analgesic (IM morphine) use
Measured: Through study completion, an average of 7 days
Time of recovery from postoperative syndrome
Measured: Through study completion, an average of 7 days
Quality of recovery (QoR-9)
Measured: Through study completion, an average of 7 days
SF-6D
Measured: Through study completion, an average of 7 days
EQ-5D-5L
Measured: Through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study start12 Oct 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lixing LAO, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851186
- Sponsor's protocol ID
- UW 15-459
- Status last verified
- Sep 2019
- First submitted
- 19 Jul 2016
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 29301556
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Electroacupuncture and Auricular Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases: A Randomized Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT02851186
- Acronym / sponsor ID
- UW 15-459
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture (EA) and Auricular Acupuncture (AA) | Experimental | Device: AcupunctureSubjects 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. |
| Sham acupuncture | Sham comparator | Device: Sham acupunctureSubjects in the control group will receive non-invasive sham procedure in the same schedule as the treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture | Device | Electroacupuncture (EA) and Auricular Acupuncture (AA) |
| Sham acupuncture | Device | Sham acupuncture |
Primary outcome
Area under the curve of Pain intensity by numerical rating scale (NRS) from baseline to day 5
Time frame: 5 days
9 secondary outcomes
Pain intensity by numerical rating scale (NRS) at rest
Time frame: Through study completion, an average of 7 days
Pain intensity by numerical rating scale (NRS) while coughing
Time frame: Through study completion, an average of 7 days
Cumulative morphine consumption
Time frame: Through study completion, an average of 7 days
Dose of rescues analgesic (IM morphine) use
Time frame: Through study completion, an average of 7 days
Frequency of rescues analgesic (IM morphine) use
Time frame: Through study completion, an average of 7 days
Time of recovery from postoperative syndrome
Time frame: Through study completion, an average of 7 days
Quality of recovery (QoR-9)
Time frame: Through study completion, an average of 7 days
SF-6D
Time frame: Through study completion, an average of 7 days
EQ-5D-5L
Time frame: Through study completion, an average of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Derived from this study: PubMed 29301556Lam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lixing LAO principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Postoperative Pain, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of Pain intensity by numerical rating scale (NRS) from baseline to day 5 (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02851186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.