Effect of Acupuncture on Nausea, Vomiting, Pain, PGE2 and IL 6 in Septorhinoplasty

Pain Clinical Trial

Official title:

Effect of Acupuncture on Nausea, Vomiting, Pain, PGE2 and IL 6 in Septorhinoplasty Operations; Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04009070
• Other study ID #: 2018/12-17
• Status: Completed
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: August 2022
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 30, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• ASA I-II group

• Aged 18-75

• Volunteer to participate in the study

• Conscious patients.

Exclusion Criteria:

• Not wanting to participate

• Unconscious

• Having a hearing and speech problem

• Allergic disease and bleeding disorder

• Respiratory problems

Related Conditions & MeSH terms

• Acupuncture
• Pain
• Vomiting

Intervention

Device:
• Acupuncture Pres Needle: 0.22x1.5 mm needle
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.

Locations

Country	Name	City	State
Turkey	Kahramanmaras Sutcu Imam University Faculty of Medicine	Kahramanmaras	Onikisubat

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Pain Scores	VAS (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated	5 minute,30 minute, 60 minute, 3 hours, 6 hours, 12 hours, 24 hours after the operation
Primary	PG E2	To evaluate the impact on the circulating levels of PG E2 ng/ml	Change from baseline and concentration of preoperativ and postoperative values at 24.hours
Primary	IL 6	To evaluate the impact on the circulating levels of IL 6 ng/ml	Change from baseline and concentration of preoperativ and postoperative values at 24.hours
Primary	Nause and Vomiting	Yes or No Nause and vomiting	After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours
Secondary	Blood Pressure	Systolic blood pressue mmHg , diastolic blood pressure mmHg, mean arterial pressure mmHg,	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
Secondary	Heart rate	heart rate ,	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
Secondary	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.	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
Secondary	oxygen follow-up	oxygen saturation	at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes during
Secondary	oxygen follow-up	oxygen saturation	30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours after the operation,