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Trial registered on ANZCTR


Registration number
ACTRN12621000287831
Ethics application status
Approved
Date submitted
22/11/2020
Date registered
16/03/2021
Date last updated
16/03/2021
Date data sharing statement initially provided
16/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title

Acupuncture for complementary pain relief following tonsillectomy in adults
Scientific title
Efficacy of acupuncture as complementary analgesic for post-tonsillectomy pain in adults – a prospective randomised clinical trial of effects and safety
Secondary ID [1] 300577 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tonsillectomy 316313 0
Condition category
Condition code
Anaesthesiology 314579 314579 0 0
Pain management
Oral and Gastrointestinal 314580 314580 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Intraoperative acupuncture during tonsillectomy procedure

Why: To assess if intraoperative acupuncture can affect postoperative pain score

How: With approval from the Hospital Ethics Committees, we plan to enroll 260 adults who are undergoing tonsillectomy into our study.
All prospective patients receive written informed consent prior to surgery. All patients are interviewed and consented by the anaesthetist the night before or on the day of surgery. They are all given a chance to ask questions at the interview and any further queries are to be addressed prior to the procedure.

All patients have their intravenous cannula inserted in the induction bay and also have 5 auricular acupuncture needles pads attached to each ear. In the acupuncture group, the Serin paper needle pads with a very small (0. 6mm) embedded needles are used. In the control group, the sham paper pads without needles were used instead. The needles in these sham paper pads were removed by the author prior to the operation day. In all patients, these needle pads are to remained in place for 5 days, and then removed by patients at home.

The patients are then brought into the operating room for induction of anaesthesia.

In the acupuncture group, immediately following induction of anaesthesia and prior to surgical stimulation, ten (10) body acupuncture needles are inserted prior to surgical stimulation. A standard surgical tonsillectomy with diathermy is then carried out. At the end of surgery, the body acupuncture needles are removed. The patients are then woken up and taken out to recovery.

In the control group, an identical procedure to that described above was followed, without the insertion of ten (10) acupuncture needles.




What:
For auricular acupuncture, paper pads with an embedded needle 0.2mm in diameter and 0.6mm in length were used (Serin Co, Shizuoka, Japan). In the control group, the needles were removed with a surgical needle holder by the author prior to the operation day to provide sham paper pads without needles.

For body acupuncture: Stainless steel acupuncture needles, 15 mm in length and 0.18 mm in diameter (Serin Co, Shizuoka, Japan), were used. The positions for the needles inserted, according to Chinese Medicine standards, are: LI4 bilaterally, LI20/Bitong bilaterally, CV(REN)22, GV(DU)20, LU1, PC6, ST44, SP6.

Who:All needle acupunctures were performed by Dr David Ho, an anaesthetist and a qualified acupuncturist with certification from the Australian College of Medical Acupuncturist (AMAC).
Where: all procedures were performed in operating rooms at Northwest Private Hospital
When/How much: All acupuncture is done only once.The body acupuncture needles were left in situ for the duration of surgery, and immediately removed at the completion of surgery prior to the patient being transferred to recovery room. The auricular acupuncture needles are left in-situ for 5 days postoperative and removed by patients at home.

Documentation/ Monitoring:
All patients enrolled are noted to have acupuncture (AC) intervention recorded on their anaesthetic record. A separate record for their in-hospital Pains Scores are included in their Medical Record which is filled out by nursing staff and doubled check against their own Pain Scores on hospital ward chart and Oxycodone does on the Medication chart. Another record is given for patients to record their Pain Scores and Oxycodone doses at home. Both of these are collected and collated by the research nurses when completed.

Immediately after the removal of acupuncture needles, all insertion sites are inspected for possible bleeding or erythema. These common complications are recorded on the acupuncture collection sheets, as well as any reported rare complications such as neurological impairment.
Intervention code [1] 316884 0
Treatment: Other
Intervention code [2] 319431 0
Treatment: Devices
Comparator / control treatment
For auricular acupuncture, the process is exactly the same in the 2 groups in the awake patient. However, In the control group, the sham paper pads without needles were used instead of real paper pads with embedded needles for auricular acupuncture.

For body acupuncture, the only difference is that in the control group, patients do not receive body acupuncture. In the acupuncture group, ten body acupuncture needles are ionserted after the patients are sleep and removed prior to awakening.
Control group
Active

Outcomes
Primary outcome [1] 322909 0
Pain score following tonsillectomy as assessed by the 0-10 Numerical Pain scale with the intervention of intraoperative acupuncture.
Timepoint [1] 322909 0

in the first 24 postoperative hours in hospital and on day 1,2 5 at home.
Secondary outcome [1] 380216 0
Oxycodone requirement following tonsillectomy as assessed by the number of doses given by nurses in hospital and by patients at home with the intervention of intraoperative acupuncture.
A separate record for their in-hospital Pains Scores are included in their Medical Record which is filled out by nursing staff and doubled check against their own Pain Scores on hospital ward chart and Oxycodone does on the Medication chart. Another record is given for patients to record their Pain Scores and Oxycodone doses at home. Both of these are collected and collated by the research nurses when completed.
Timepoint [1] 380216 0

in the first 24 postoperative hours in hospital and on postoperative days 1,2 and 5 at home
Secondary outcome [2] 391838 0
To qualitatively assess possible complications and safety of intraoperative acupuncture. Immediate complications such as erythema or bleeding is noted and recorded by staff in data collection sheets. Delayed reactions such as numbness or localised pain are queried by nursing staff and research nurses and recorded on data collection sheets.
Timepoint [2] 391838 0
in the first 24 postoperative hours in hospital and on day 1,2 5 at home.

Eligibility
Key inclusion criteria
Healthy adults undergoing tonsillectomy
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included any significant allergy, known bleeding tendency, known or likely airway difficulty and anybody who had received acupuncture, analgesics or sedatives within 36 hours prior to surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To minimise allocation bias, this randomisation programme was held by an independent collaborator. On the day of surgery, the anaesthetist would contact the independent collaborator with the names of the patients. The independent collaborator would then assign the patients to the respective groups and inform the anaesthetist just prior to the procedure as to which group the patients had been assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients were randomised in blocks of 50 and assigned by a computer-generated programme to either the control or the acupuncture group. To minimise allocation bias, this randomisation programme was held by an independent collaborator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All our statistical analyses were performed by an independent statistician. Differences in demographic data were analysed using t-tests for continuous variables and chi-squared tests for categorical variables. Outcome data were analysed using simple linear regression for continuous variables and logistic regression for categorical variables. Data analysis was conducted using Stata v14.2 (StataCorp, College Station, TX, USA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
220
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15914 0
North West Brisbane Private Hospital - Everton Park
Recruitment postcode(s) [1] 29372 0
4053 - Everton Park

Funding & Sponsors
Funding source category [1] 304999 0
Self funded/Unfunded
Name [1] 304999 0
Dr David Ho
Country [1] 304999 0
Australia
Primary sponsor type
Individual
Name
Dr David Ho
Address
Dr David Ho - Northside Anaesthesia, Level 3, Mary Aitkenhead Building, St Vincents Private Hospital Northside, 627 Rode Rd, Chermside 4032, Queensland, Australia
Country
Australia
Secondary sponsor category [1] 305353 0
None
Name [1] 305353 0
Address [1] 305353 0
Country [1] 305353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305396 0
Greenslopes Research and Ethics Committee
Ethics committee address [1] 305396 0
Greenslopes Private Hospital Medical Services Address: Newdegate St, Greenslopes QLD 4120
Ethics committee country [1] 305396 0
Australia
Date submitted for ethics approval [1] 305396 0
14/09/2016
Approval date [1] 305396 0
13/12/2016
Ethics approval number [1] 305396 0
16/53

Summary
Brief summary
Summary

Aim: To investigate the effect of intraoperative acupuncture on postoperative pain in adults following tonsillectomy.

Background: Tonsillectomy is usually accompanied by significant morbidity, including postoperative bleeding, pain, nausea, vomiting, poor oral intake and dehydration. Recent evidences in literature indicate that acupuncture may have a role in reducing postoperative pain in adults and children.

Methods: This prospective randomized controlled trial is to evaluate the effectiveness of intraoperative acupuncture in reducing pain following tonsillectomy in 260 adults. All patients receive a standardised anaesthesia and surgery including intraoperative Oxycodone, Dexamethasone, Granisetron and Paracetamol. Preoperatively, all patients receive ten (10) auricular acupuncture pads in preoperative bay. In the acupuncture group, the acupuncture pads contain a small (0.15mm x 0.6mm) embedded needle in-situ. In the control group, the sham acupuncture pads look identical but the needle has already been removed prior to insertion. These are left in-situ for 5 days and removed by patients at home.

Intraoperatively, in the acupuncture group, body acupuncture needles (0.18mm x 15mm) are applied at 10 specified points immediately after induction of anaesthesia. These are removed after surgery and before the patients wake up. In the control group, no body acupuncture needles are given. Postoperative pain relief consisted of regular Paracetamol and Oxycodone as required. All patients and nursing staffs are blinded. All assessors evaluated postoperative pain using the 0-10 Numerical pain scale. Pain scores were recorded at regular intervals during the first 24 hours by nurses in hospital and on day 1,2 and 5 following discharge by patients at home.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100234 0
Dr David Ho
Address 100234 0
Northside Anaesthesia, Level 3, Mary Aitkenhead Building, St Vincents Private Hospital Northside, 627 Rode Rd, Chermside 4032, Queensland, Australia.
Country 100234 0
Australia
Phone 100234 0
+61 733597011
Fax 100234 0
+61 733597022
Email 100234 0
[email protected]
Contact person for public queries
Name 100235 0
David Ho
Address 100235 0
Northside Anaesthesia, Level 3, Mary Aitkenhead Building, St Vincents Private Hospital Northside, 627 Rode Rd, Chermside 4032, Queensland, Australia.
Country 100235 0
Australia
Phone 100235 0
+61 733597011
Fax 100235 0
+61 733597022
Email 100235 0
[email protected]
Contact person for scientific queries
Name 100236 0
David Ho
Address 100236 0
Northside Anaesthesia, Level 3, Mary Aitkenhead Building, St Vincents Private Hospital Northside, 627 Rode Rd, Chermside 4032, Queensland, Australia.
Country 100236 0
Australia
Phone 100236 0
+61 733597011
Fax 100236 0
+61 733597022
Email 100236 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7073Study protocol    379294-(Uploaded-22-11-2020-19-35-02)-Study-related document.docx
7074Ethical approval    379294-(Uploaded-22-11-2020-19-35-56)-Study-related document.pdf
7075Informed consent form    379294-(Uploaded-22-11-2020-19-36-21)-Study-related document.docx



Results publications and other study-related documents

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