The efficacy of the EmeTerm bracelet in preventing postoperative nausea and vomiting
| ISRCTN | ISRCTN60848297 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60848297 |
- Submission date
- 10/11/2023
- Registration date
- 12/11/2023
- Last edited
- 21/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Postoperative nausea and vomiting are common complications after total joint arthroplasty. Recent research has shown that the EmeTerm bracelet can safely and effectively reduce the incidence of nausea and vomiting after general surgery. However, there is no research in the field of joint replacement. Therefore, this study will explore the effects of the EmeTerm bracelet in treating nausea and vomiting after total joint arthroplasty.
Who can participate?
Patients at our hospital were eligible for enrollment if they (1) were scheduled for primary unilateral THA or TKA under spinal anesthesia between November 2023 and April 2024 to treat osteoarthritis or other joint diseases at an advanced stage; (2) were between 18 and 75 years old; and (3) scored 2 (moderate risk) or 3-4 (high risk) for PONV on Apfel scale.
What does the study involve?
Patients need to wear the bracelet in a fixed location and at a fixed time. The test group will receive stimulation while the control group will not.
What are the possible benefits and risks of participating?
The possible benefits of this study are less nausea and vomiting after surgery. There are rarely any risks from the bracelets, and the occasional adverse reactions are local skin reactions, including local skin redness, itching, and rash.
Where is the study run from?
Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province (China)
When is the study starting and how long is it expected to run for?
March 2023 to February 2024
Who is funding the study?
Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province (China)
Who is the main contact?
Ms Yang, 709925524@qq.com (China)
Contact information
Public, Scientific, Principal Investigator
No. 82 Qiming South Road
Luoyang City, Henan Province
471000
China
| Phone | +86 17839954318 |
|---|---|
| 709925524@qq.com |
Study information
| Study design | single-center interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | 44567_PIS.pdf |
| Scientific title | Risk of postoperative nausea and vomiting after total hip or knee arthroplasty under spinal anesthesia: randomized trial comparing conventional anti-emetics with or without EmeTerm® bracelet |
| Study objectives | The EmeTerm bracelet is effective in preventing postoperative nausea and vomiting after total joint arthroplasty |
| Ethics approval(s) |
Approved 10/10/2023, Ethics Committee of Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province (No. 82 Qiming South Road, Luoyang City, Henan Province, 471000, China; +86 379 63546181; lyzgll@sina.com), ref: 2023ZXKT0006-01 |
| Health condition(s) or problem(s) studied | Prevention of postoperative nausea and vomiting in patients with total joint arthroplasty under spinal anesthesia |
| Intervention | Current interventions as of 21/10/2024: Randomization: To enhance the baseline comparability, THA and TKA have been chosen as stratification factors. A researcher who is not involved in subsequent studies will stratify the included patients based on THA and TKA, and use computer-generated random sequences which are put in a sealed envelope to stratify random grouping. Patients will be divided into a control group and a test group. In the test group, patients will wear the EmeTerm bracelet on both sides of the acupoints named Neiguan (on the palmar side of the forearm, between the proximal end of the wrist striation 3-5cm, between the palmaris longus tendon and the radial wrist flexor tendon), usually at a frequency of 2/10 Hz, to make the patient feel slight numbness on the radial side of the palm, lasting for 30 minutes each time. It is applied once half an hour before anesthesia induction, once after surgery until the ward, and then every 3 hours until the bracelet is removed 24 hours after surgery. In the control group, the anti-dizziness bracelet will be worn at the same time and location, but without stimulation. _____ Previous interventions: Randomization: To enhance the baseline comparability, female and motion sickness history have been chosen as stratification factors. A researcher who is not involved in subsequent studies will stratify the included patients based on gender and history of motion sickness, and use computer-generated random sequences which are put in a sealed envelope to stratify random grouping. Patients will be divided into a control group and a test group. In the test group, patients will wear the EmeTerm bracelet on both sides of the acupoints named Neiguan (on the palmar side of the forearm, between the proximal end of the wrist striation 3-5cm, between the palmaris longus tendon and the radial wrist flexor tendon), usually at a frequency of 2/10 Hz, to make the patient feel slight numbness on the radial side of the palm, lasting for 30 minutes each time. It is applied once half an hour before anesthesia induction, once after surgery until the ward, and then every 3 hours until the bracelet is removed 24 hours after surgery. In the control group, the anti-dizziness bracelet will be worn at the same time and location, but without stimulation. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | EmeTerm ®, Canadian Walter Company, Chinese name Shuleding ® |
| Primary outcome measure | Current primary outcome measure as of 21/10/2024: 1. The incidence of PONV within 24 h postoperatively _____ Previous primary outcome measure: 1. The total number and frequency of patients experiencing nausea and vomiting measured using patient records 24 hours after surgery 2. Number and frequency of patients experiencing nausea and vomiting measured using patient records at 0-3, 3-12, and 12-24 hours after surgery 3. The severity of nausea and vomiting measured using patient records 24 hours after surgery |
| Secondary outcome measures | Current secondary outcome measures as of 21/10/2024: 1. The rates within 24 h postoperatively: complete response of PONV and severe PONV 2. The rate of PONV during different postoperative intervals (0-3 h, 3-6 h, 6-12 h, 12-24 h) 3. The rate of metoclopramide rescue within 24 h postoperatively 4. The rate of bracelet-related adverse events, defined as local allergic reactions on the skin 5. The quality of recovery at 24 and 48 h postoperatively using the 40-item Quality of Recovery (QOR-40) instrument _____ Previous secondary outcome measures: 1. The usage rate and dosage of postoperative nausea and vomiting remedies measured using patient records 24 hours after surgery 2. The incidence of equipment-related complications measured using patient records 24 hours after surgery |
| Overall study start date | 12/03/2023 |
| Completion date | 29/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 140 |
| Total final enrolment | 360 |
| Key inclusion criteria | Current inclusion criteria as of 21/10/2024: Patients at our hospital were eligible for enrollment if they (1) were scheduled for primary unilateral THA or TKA under spinal anesthesia between November 2023 and April 2024 to treat osteoarthritis or other joint diseases at an advanced stage; (2) were between 18 and 75 years old; and (3) scored 2 (moderate risk) or 3-4 (high risk) for PONV on Apfel scale _____ Previous inclusion criteria: Patients aged 18-75 who require unilateral and initial total joint arthroplasty due to hip or knee joint disease. |
| Key exclusion criteria | Current exclusion criteria as of 21/10/2024: 1. Were allergic to metal or study medications 2. Had a pacemaker, implantable glucose monitor, or cochlear implant 3. Had taken anti-emetics or systemic steroids within the previous week 4. Had diabetes and did not show adequate control of blood glucose 5. Suffered severe dysfunction of the heart, kidneys, or liver _____ Previous exclusion criteria: 1. Cardiac pacemakers, blood glucose meters, or cochlear implants 2. Epilepsy 3. Metal contact allergies 4. Nausea and vomiting within one week before admission 5. Any surgery within one month prior to admission |
| Date of first enrolment | 20/11/2023 |
| Date of final enrolment | 26/04/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Luoyang City, Henan Province
471000
China
Sponsor information
Hospital/treatment centre
Department of Orthopedic Surgery
No. 82 Qiming South Road
Luoyang City, Henan Province
471000
China
| Phone | +86 0379-63546550 |
|---|---|
| zgyy6354@sina.com | |
| Website | http://www.lyzhenggu.cn/ |
"ROR" |
https://ror.org/05br7cm44 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Ms Yang (709925524@qq.com). Consent will be obtained from participants to share anonymised data. This will be made available subject to a data-sharing agreement. Data will only be shared after there is an appropriate agreement in place and anonymised prior to sharing. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 10/11/2023 | No | Yes |
Additional files
Editorial Notes
21/10/2024: The following changes were made to the trial record:
1. The scientific title was changed from "EmeTerm bracelet for prevention of postoperative nausea and vomiting in patients undergoing total joint arthroplasty: a randomised controlled trial" to "Risk of postoperative nausea and vomiting after total hip or knee arthroplasty under spinal anesthesia: randomized trial comparing conventional anti-emetics with or without EmeTerm® bracelet".
2. The overall end date was changed from 29/02/2024 to 29/04/2024.
3. The interventions were changed.
4. The primary outcome measure was changed.
5. The secondary outcome measures were changed.
6. The inclusion criteria were changed.
7. The total final enrolment was added.
8. The exclusion criteria were changed.
9. The recruitment start date was changed from 01/12/2023 to 20/11/2023.
10. The recruitment end date was changed from 28/02/2024 to 26/04/2024.
11. The intention to publish date was changed from 30/09/2024 to 30/12/2024.
12. The plain English summary was updated to reflect these changes.
10/11/2023: Study's existence confirmed by the Ethics Committee of Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province (China).
