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

Acupuncture for Enhancing Recovery and Attenuating Postoperative Nausea and Vomiting After Middle Ear Surgeries: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Treatment Complication
• Intervention / Treatment: Device: acupuncture needles; Other: placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Recruiting
    • Zagazig University
    • Contact: Marwa Zakzouk, MD; Phone Number: 002 01004178761; Email: dr.marwa.zu@gmail.com
    • Contact: Alshaimaa Kamel; Phone Number: 01005593169; Email: Alshaimaakamel80@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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
Placebo Comparator: placebo; no treatment	Other: placebo; no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postoperative nausea and vomiting	Postoperative nausea and vomiting impact scale score . Questions Answers score Did you have vomiting or dry retching? No 0 Once 1 Twice 2 Three or more times 3 Have you experienced a feeling of nausea? If yes, has it interfered with your daily activities? Not at all 0 Sometimes 1 Often/most of the times 2 All the time 3 Summation of numerical answer to question 1 plus 2 equal the PONV impact scale. PONV Impact Scale Score of ≥5 represents clinically important PONV	up to 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
extubation time	time from discontinuation of isoflurane to extubation	up to 10 minutes postoperative
recovery time	time from discontinuation of isoflurane to first response to verbal command	up to 30 minutes postoperative
The time of discharge	The time from arrival to PACU to discharge to the ward) according to Modified Aldert score Modified Aldert score . Assessment item Condition Grade Activity, able to move, voluntarily or on command 4 extremities 2 2 extremities 1 No 0 Breathing Able to breathe deeply & cough freely 2 Dyspnea, shallow or limited breathing 1 Apnea 0 Consciousness Fully awake 2 Arousable on calling 1 Unresponsive 0 Circulation (blood pressure) ±20% of pre-anesthesia level 2; 20% to 49% of pre-anesthesia level 1; 50% of pre-anesthesia level 0 SPO2 Maintain SPO2 >92% in ambient air 2 Maintain SPO2 >90% with O2 1 Maintain SPO2 <90% with O2 0 Patient having a score of 9 or higher is discharged	up to 30 minutes postoperative
The total number of rescue antiemetic (metoclopramide)	Any patient will receive 10 mg intravenous metoclopramide immediately if there is nausea and vomiting	in the first 24 hour postoperative
Postoperative Pain	Visual Analogue Scale (VAS) . A commonly used scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. IV paracetamol 1 gm every 6hs as a protocol for pain management and IV pethidine 30 mg as rescue analgesic will be given if VAS ≥ 4. Total doses and number of analgesics will be recorded	up to 30 minutes, 2 hours and 4 hours postoperative
number of participant with side effects of acupuncture	bleeding, soreness, or bruising at the site of needle insertion	up to 24 hours postoperative

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Marwa Zakzouk, MD, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 6658

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No