Acupuncture for Recovery and Postoperative Nausea and Vomiting After Middle Ear Surgeries

NCT ID: NCT04748133

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-20
• Study Completion Date: 2021-07-01

Brief Summary

Modern surgery management needs increasing operating room turnover and more ambulatory surgery. In order to come over this challenge, the recovery needs to be optimized. Enhancing recovery could be achieved by preventing postoperative pain and postoperative nausea and vomiting. Middle ear surgery is a common ambulatory surgery with increasing occurrence of postoperative nausea and vomiting.

Detailed Description

Sample size: as percent of vomiting following acupuncture and following standard anesthesia is 0.13% and 29.2% respectively so sample size is 58 (29 in each group). Sample is calculated using open epi program with confidence level 95% and power 80%.

Patients in Group C (control group) (n=29): will receive no treatment. While patients in Group A (Acupuncture group) (n=29): will receive needle acupuncture.

Conditions

Treatment Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

acupuncture

Patients in the acupuncture group will receive a standardised treatment with 12 needles (sharp tip, stainless steel needles, size 0.3 X 40 mm) at 7 acupuncture points Du 26 and Ren 17 (on the middle body line), and bilateral LI 4, HE 7, LV 3, ST 36 and PC 6). Application of the needles is performed by a licensed medical acupuncturist.

The needles will be inserted after endotracheal intubation and mechanical ventilation and will be removed immediately before patient extubation.

Group Type: ACTIVE_COMPARATOR

acupuncture needles

Intervention Type: DEVICE

Site of acupuncture points:

• Du 26: At junction of the upper and middle third of philtrum.
• Ren 17: On the midline level with the 4th intercostal space midway between the nipples.
• LI4 (Large Intestine 4): On the dorsum of the hand, between the 1st and 2nd metacarpal bones
• HT7 (Heart 7): On the ulnar end of the transverse crease of the wrist, in the small depression between the pisiform and ulna bones
• LV3 (Liver 3): On dorsum of the foot in a depression distal to the junction of the 1st and 2nd metatarsal bones.
• ST36 (Stomach 36): Antero-lateral leg, 1 middle-finger breadth next to the anterior crest of tibia, 3 cun under the depression lateral to the patellar ligament.
• PC6 (Pericardium 6): Palmar aspect of the forearm, between the tendons, 2 cun away from the transverse crease of the wrist

placebo

no treatment

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

no treatment

Interventions

acupuncture needles

Site of acupuncture points:

• Du 26: At junction of the upper and middle third of philtrum.
• Ren 17: On the midline level with the 4th intercostal space midway between the nipples.
• LI4 (Large Intestine 4): On the dorsum of the hand, between the 1st and 2nd metacarpal bones
• HT7 (Heart 7): On the ulnar end of the transverse crease of the wrist, in the small depression between the pisiform and ulna bones
• LV3 (Liver 3): On dorsum of the foot in a depression distal to the junction of the 1st and 2nd metatarsal bones.
• ST36 (Stomach 36): Antero-lateral leg, 1 middle-finger breadth next to the anterior crest of tibia, 3 cun under the depression lateral to the patellar ligament.
• PC6 (Pericardium 6): Palmar aspect of the forearm, between the tendons, 2 cun away from the transverse crease of the wrist

Intervention Type: DEVICE

placebo

no treatment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Written informed consent from the patient.
• Age: 21-60 years old.
• Sex: both sex (males or females).
• Physical status: ASA 1& II.
• BMI = (20-30 kg/m2).
• Type of operations: elective unilateral middle ear surgeries such as tempanoplasty, stapedectomy and mastedictomy.

Exclusion Criteria

• Altered mental state
• Patients with Drug abuse or alcohol.
• Patients with on antipsychotic drugs, regular antiemetic therapy or receiving antiemetic 24 hour before surgery.
• Patients with pre-treatment with acupuncture or trigger point injection.
• Pregnancy.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Marwa Mahmoud Abd Allah Zakzouk

Lecturer of Anesthesia & Surgical Intensive Care, Zagazig University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa Zakzouk, MD

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

Zagazig University

Zagazig, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Marwa Zakzouk, MD

Role: CONTACT

dr.marwa.zu@gmail.com

01004178761 ext. 002

Al shaimaa Kamel, MD

Role: CONTACT

AlshaimaaKamel80@yahoo.com

01005593169 ext. 002

Facility Contacts

Marwa Zakzouk, MD

Role: primary

dr.marwa.zu@gmail.com

01004178761 ext. 002

Alshaimaa Kamel

Role: backup

Alshaimaakamel80@yahoo.com

01005593169

Other Identifiers

6658

Identifier Type: -

Identifier Source: org_study_id