Injection PainNCT04943367
Effect of TEAS on Rocuronium Injection Pain
A study testing TEAS in people with Injection Pain, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pain from the injection of rocuronium is a common side effect during anesthetic practice, occurring in 50%-80% of patients. Several methods have been used to reduce this pain. This prospective, randomized study was designed to determine the efficacy of transcutaneous electrical acupuncture point stimulation in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Pain
- What is being tested?
- TEAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jul 2021to 5 Jan 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 year aged
- ASA I-III
- Who was to undergo various elective operations.
Who cannot join
- Cardiovascular surgery
- Patients with pacemakers
- Patients requiring rapid sequential induction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of TEAS On Prevention of Rocuronium Injection Pain
Pain from the injection of rocuronium is a common side effect during anesthetic practice, occurring in 50%-80% of patients. Several methods have been used to reduce this pain. This prospective, randomized study was designed to determine the efficacy of transcutaneous electrical acupuncture point stimulation in reducing the rocuronium injection pain.
- Conditions
- Injection Pain
- Being tested
- TEAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEASDevice
Transcutaneous electrical acupuncture stimulation
| Study group | Role | What they receive |
|---|---|---|
| GROUP TEAS | Active comparator | Patients will receive TEAS bilaterally at two acupoints: Hegu (L14) and Neiguan (PC6). Receives: Device: TEAS |
| Control Sham Group | Placebo comparator | Patients in the sham group will be undergoing electrode attachment on the target acupoints without electronic stimulation. Receives: Device: TEAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain with rocuronium injection
pain will be graded as no pain; mild pain; moderate pain; severe pain following administration of a priming dose of rocuronium
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start12 Jul 2021
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection PainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Kozanhan, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943367
- Sponsor's protocol ID
- Rocuronium injection pain
- Status last verified
- Jan 2022
- First submitted
- 18 Jun 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of TEAS On Prevention of Rocuronium Injection Pain
- ClinicalTrials.gov ID
- NCT04943367
- Acronym / sponsor ID
- Rocuronium injection pain
- Conditions
- Injection Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 29 Jun 2021 (actual)
- 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.
Pain from the injection of rocuronium is a common side effect during anesthetic practice, occurring in 50%-80% of patients. Several methods have been used to reduce this pain. This prospective, randomized study was designed to determine the efficacy of transcutaneous electrical acupuncture point stimulation in reducing the rocuronium injection pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP TEAS | Active comparator | Device: TEASPatients will receive TEAS bilaterally at two acupoints: Hegu (L14) and Neiguan (PC6). |
| Control Sham Group | Placebo comparator | Device: TEASPatients in the sham group will be undergoing electrode attachment on the target acupoints without electronic stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 year aged
- ASA I-III
- Who was to undergo various elective operations.
Key exclusion criteria (3 listed)
- Cardiovascular surgery
- Patients with pacemakers
- Patients requiring rapid sequential induction
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 |
|---|---|---|
| TEASTranscutaneous electrical acupuncture stimulation | Device | Control Sham Group, GROUP TEAS |
Primary outcome
Pain with rocuronium injection
Time frame: 5 minutes
pain will be graded as no pain; mild pain; moderate pain; severe pain following administration of a priming dose of rocuronium
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 6 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS in people with Injection Pain, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Pain with rocuronium injection (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2022.