PainNCT04009070
Effect of Acupuncture on Nausea, Vomiting, Pain, PGE2 and IL 6 in Septorhinoplasty
A study testing Acupuncture Pres Needle: 0.22x1.5 mm needle in people with Pain and Acupuncture, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Acupuncture has emerged in China about 2,000 years ago and is one of the oldest medical procedures in the world.Later acupuncture was introduced to other regions such as Asia, Europe and the United States.The most extensive use of acupuncture is for pain relief.Especially, postoperative nausea and vomiting have been… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Pain, Acupuncture
- What is being tested?
- Acupuncture Pres Needle: 0.22x1.5 mm needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2019to 30 Apr 2020
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II group
- Aged 18-75
- Volunteer to participate in the study
- Conscious patients.
Who cannot join
- Not wanting to participate
- Unconscious
- Having a hearing and speech problem
- Allergic disease and bleeding disorder
- Respiratory problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University Faculty of Medicine
Kahramanmaraş, Onikişubat, 251/A 46040
About this study
Official title: Effect of Acupuncture on Nausea, Vomiting, Pain, PGE2 and IL 6 in Septorhinoplasty Operations; Prospective, Randomized, Controlled Study
Acupuncture has emerged in China about 2,000 years ago and is one of the oldest medical procedures in the world.Later acupuncture was introduced to other regions such as Asia, Europe and the United States.The most extensive use of acupuncture is for pain relief.Especially, postoperative nausea and vomiting have been studied.In one study, PC6 (approximately two cm above the midline of the wrist line) showed antiemetic effect, with the addition of other acupuncture points, it proved to have a protective effect in the treatment of postoperative nausea and vomiting.ST36 (Approximately 1-2 cm laterally from the tuberocyte tibia) is an acupuncture point used in the treatment of diseases such as inflammation, acute pain, hypertension and gastrointestinal disorders.
Read the detailed description
Patients will be determined as Group A: Acukupuncture group and Group C as Control group and 35 patients will be included in the study. Both groups will be given an intravenous (i.v) route in the preoperative patient room, PGE2, IL 6 will be taken for blood and 0.09% NaCl will be started. Group A preoperatively, 24 hours prior to bilateral PC6 (approximately two cm above the midline of the wrist line) and ST 36 (approximately 1-2 cm laterally from the Tibia) to be applied to the press needle (0.22x1.3 mm) and the tape (Needle Press will remain for 24 hours after surgery. Electrocardiography (ECG), noninvasive blood pressure (SBP-DBP), and peripheral arterial oxygen saturation (SpO2) monitoring will be applied to the patients. In the induction of anesthesia, Pentotal 5 mg / kg, Fentanyl 0.5 mcg / kg, and rocuronium 0.6 mg / kg will be used. Anesthesia maintenance will be provided with a 2% concentration of sevoflurane, 50% nitrous oxide (N2O) and 50% oxygen (O2) mixture and appropriately intubated. Patients will be recorded with systolic blood pressure (SBP), diastolic blood pressure (heart failure), heart rate (HR), mean arterial pressure (MAP) and SpO2, 5, 15, 30, 60, 120 minutes (min) after induction.
Patients in Group A and Group C had a saturation value of 97% or more, and exhaled if breathing effort was sufficient. Atropine and neostigmine will be used to neutralize muscle relaxants. Contramal 1mg / kg will be applied to the patients as standard by 20 minutes before the end of surgery. Following the termination of the surgical intervention, the anesthesia gases will be cut and 100% O2 will be inhaled with the mask until all the cases are compiled. 5.dk follow-up and extubation period of the patients will be taken to the postoperative rest room after being followed up on the operating table. 30. Min follow-up will be sent to their services after being done here. Postoperative 60 min, 3 h, 6 h, 12 h, 24 h, sore throat, nausea, vomiting, cough, itching, dysphagia, sore throat and analgesic needs, whether pain, assessment will be made. VAS score will be used to evaluate pain. Paracetamol will be applied to all patients when analgesia needs. At 24 hours postoperatively, blood will be taken to look for PGE2 and IL6 values.Preoperative and postoperative PGE2 and IL 6 values will be compared between the groups of the acupuncture group and the control group.
- Conditions
- Pain, Acupuncture
- Being tested
- Acupuncture Pres Needle: 0.22x1.5 mm needle
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture Pres Needle: 0.22x1.5 mm needleDevice
Acupunctur group; Acupunctur preoperatively 24 hours before bilateral PC6 (approximately two cm above the midline of the wrist line) and ST 36 (approximately 1-2 cm laterally from the tuberocyte tibia). The tape (Needle Press) will remain for 24 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | Group A: Acupuncture group:Group A: Acupunctur will be applied to the Acupunctur group 24 hours prior to bilateral PC6 (approximately two cm above the midline of the wrist line) and ST 36 (approximately 1-2 cm laterally on the tibia) . The tape (Needle Press) will stay for 24 hours.
Needle Press: Pres Needle: 0.22x1.5 mm needle Receives: Device: Acupuncture Pres Needle: 0.22x1.5 mm needle |
| Control Group | No intervention | Group C: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Pain Scores
VAS (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
Measured: 5 minute,30 minute, 60 minute, 3 hours, 6 hours, 12 hours, 24 hours after the operation
PG E2
To evaluate the impact on the circulating levels of PG E2 ng/ml
Measured: Change from baseline and concentration of preoperativ and postoperative values at 24.hours
IL 6
To evaluate the impact on the circulating levels of IL 6 ng/ml
Measured: Change from baseline and concentration of preoperativ and postoperative values at 24.hours
Nause and Vomiting
Yes or No Nause and vomiting
Measured: After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours
Secondary outcomes (5)
Blood Pressure
Systolic blood pressue mmHg , diastolic blood pressure mmHg, mean arterial pressure mmHg,
Measured: During operation at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes and After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours after operation
Heart rate
heart rate ,
Measured: During operation at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes and After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours
Change of Itching, cough, sore throat, difficulty in swallowing
it will be asked if there are Itching, cough, sore throat, difficulty in swallowing.more in which group.
Measured: Do Patients have any Itching, cough, sore throat, difficulty in swallowing in 5 minute,30 minute, 60 minute, 3 hours, 6 hours, 12 hours, 24 hours after operation
oxygen follow-up
oxygen saturation
Measured: at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes during
oxygen follow-up
oxygen saturation
Measured: 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours after the operation,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start15 Aug 2019
- Primary completion10 Apr 2020
- Study completion30 Apr 2020
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: Acupuncture Group Group C: Control Group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Orak, Kahramanmaras Sutcu Imam University
- Investigators
- yavuz orak, md, Principal investigator, Kahramanmaraş Sutcu Imam University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009070
- Sponsor's protocol ID
- 2018/12-17
- Status last verified
- Aug 2022
- First submitted
- 8 Mar 2019
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Orak Y, Baylan FA, Bilgen F, Orak F, Ural A, Yildiz S, Sagiroglu S, Karaduman H, Doganer A. The Effect of Acupuncture on Pain, Prostaglandin E2, and Interleukin-6 in Septorhinoplasty Operations: A Randomized Clinical Trial. Anesthesiol Res Pract. 2025 Dec 7;2025:7816719. doi: 10.1155/anrp/7816719. eCollection 2025.
PubMed 41362812
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Nausea, Vomiting, Pain, PGE2 and IL 6 in Septorhinoplasty Operations; Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT04009070
- Acronym / sponsor ID
- 2018/12-17
- Conditions
- Pain, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 5 Jul 2019 (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.
Acupuncture has emerged in China about 2,000 years ago and is one of the oldest medical procedures in the world.Later acupuncture was introduced to other regions such as Asia, Europe and the United States.The most extensive use of acupuncture is for pain relief.Especially, postoperative nausea and vomiting have been studied.In one study, PC6 (approximately two cm above the midline of the wrist line) showed antiemetic effect, with the addition of other acupuncture points, it proved to have a protective effect in the treatment of postoperative nausea and vomiting.ST36 (Approximately 1-2 cm laterally from the tuberocyte tibia) is an acupuncture point used in the treatment of diseases such as inflammation, acute pain, hypertension and gastrointestinal disorders.
Detailed description
Patients will be determined as Group A: Acukupuncture group and Group C as Control group and 35 patients will be included in the study. Both groups will be given an intravenous (i.v) route in the preoperative patient room, PGE2, IL 6 will be taken for blood and 0.09% NaCl will be started. Group A preoperatively, 24 hours prior to bilateral PC6 (approximately two cm above the midline of the wrist line) and ST 36 (approximately 1-2 cm laterally from the Tibia) to be applied to the press needle (0.22x1.3 mm) and the tape (Needle Press will remain for 24 hours after surgery. Electrocardiography (ECG), noninvasive blood pressure (SBP-DBP), and peripheral arterial oxygen saturation (SpO2) monitoring will be applied to the patients. In the induction of anesthesia, Pentotal 5 mg / kg, Fentanyl 0.5 mcg / kg, and rocuronium 0.6 mg / kg will be used. Anesthesia maintenance will be provided with a 2% concentration of sevoflurane, 50% nitrous oxide (N2O) and 50% oxygen (O2) mixture and appropriately intubated. Patients will be recorded with systolic blood pressure (SBP), diastolic blood pressure (heart failure), heart rate (HR), mean arterial pressure (MAP) and SpO2, 5, 15, 30, 60, 120 minutes (min) after induction.
Patients in Group A and Group C had a saturation value of 97% or more, and exhaled if breathing effort was sufficient. Atropine and neostigmine will be used to neutralize muscle relaxants. Contramal 1mg / kg will be applied to the patients as standard by 20 minutes before the end of surgery. Following the termination of the surgical intervention, the anesthesia gases will be cut and 100% O2 will be inhaled with the mask until all the cases are compiled. 5.dk follow-up and extubation period of the patients will be taken to the postoperative rest room after being followed up on the operating table. 30. Min follow-up will be sent to their services after being done here. Postoperative 60 min, 3 h, 6 h, 12 h, 24 h, sore throat, nausea, vomiting, cough, itching, dysphagia, sore throat and analgesic needs, whether pain, assessment will be made. VAS score will be used to evaluate pain. Paracetamol will be applied to all patients when analgesia needs. At 24 hours postoperatively, blood will be taken to look for PGE2 and IL6 values.Preoperative and postoperative PGE2 and IL 6 values will be compared between the groups of the acupuncture group and the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A: Acupuncture Group Group C: Control Group
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Device: Acupuncture Pres Needle: 0.22x1.5 mm needleGroup A: Acupuncture group:Group A: Acupunctur will be applied to the Acupunctur group 24 hours prior to bilateral PC6 (approximately two cm above the midline of the wrist line) and ST 36 (approximately 1-2 cm laterally on the tibia) . The tape (Needle Press) will stay for 24 hours. Needle Press: Pres Needle: 0.22x1.5 mm needle |
| Control Group | No intervention | –Group C: Control group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I-II group
- Aged 18-75
- Volunteer to participate in the study
- Conscious patients.
Key exclusion criteria (5 listed)
- Not wanting to participate
- Unconscious
- Having a hearing and speech problem
- Allergic disease and bleeding disorder
- Respiratory problems
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 Pres Needle: 0.22x1.5 mm needleAcupunctur group; Acupunctur preoperatively 24 hours before bilateral PC6 (approximately two cm above the midline of the wrist line) and ST 36 (approximately 1-2 cm laterally from the tuberocyte tibia). The tape (Needle Press) will remain for 24 hours after surgery. | Device | Acupuncture |
Primary outcome
Change Pain Scores
Time frame: 5 minute,30 minute, 60 minute, 3 hours, 6 hours, 12 hours, 24 hours after the operation
VAS (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
PG E2
Time frame: Change from baseline and concentration of preoperativ and postoperative values at 24.hours
To evaluate the impact on the circulating levels of PG E2 ng/ml
IL 6
Time frame: Change from baseline and concentration of preoperativ and postoperative values at 24.hours
To evaluate the impact on the circulating levels of IL 6 ng/ml
Nause and Vomiting
Time frame: After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours
Yes or No Nause and vomiting
5 secondary outcomes
Blood Pressure
Time frame: During operation at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes and After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours after operation
Heart rate
Time frame: During operation at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes and After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours
Change of Itching, cough, sore throat, difficulty in swallowing
Time frame: Do Patients have any Itching, cough, sore throat, difficulty in swallowing in 5 minute,30 minute, 60 minute, 3 hours, 6 hours, 12 hours, 24 hours after operation
oxygen follow-up
Time frame: at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes during
oxygen follow-up
Time frame: 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours after the operation,
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 12 Aug 2022.
- Derived from this study: PubMed 41362812Orak Y, Baylan FA, Bilgen F, Orak F, Ural A, Yildiz S, Sagiroglu S, Karaduman H, Doganer A. The Effect of Acupuncture on Pain, Prostaglandin E2, and Interleukin-6 in Septorhinoplasty Operations: A Randomized Clinical Trial. Anesthesiol Res Pract. 2025 Dec 7;2025:7816719. doi: 10.1155/anrp/7816719. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
yavuz orak, md principal investigator
Kahramanmaraş Sutcu Imam University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Pres Needle: 0.22x1.5 mm needle in people with Pain and Acupuncture, run by Kahramanmaras Sutcu Imam University 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 4 inclusion and 5 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 12 Aug 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. 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?
Change Pain Scores (time frame: 5 minute,30 minute, 60 minute, 3 hours, 6 hours, 12 hours, 24 hours after the operation). The study lists 4 primary outcomes in all. 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 NCT04009070, 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 12 Aug 2022.