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

Not Applicable

• Conditions: Treatment Complication
• Interventions: Device: acupuncture needles; Other: placebo

• Registration Number: NCT04748133
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-10
• Study Start: 2021-02-20
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-24
• Primary Completion: 2021-06-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture	acupuncture needles	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.
placebo	placebo	no treatment

Primary Outcome Measures

Name	Time	Method
incidence of postoperative nausea and vomiting	up to 24 hours postoperative	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

Secondary Outcome Measures

Name	Time	Method
recovery time	up to 30 minutes postoperative	time from discontinuation of isoflurane to first response to verbal command
The total number of rescue antiemetic (metoclopramide)	in the first 24 hour postoperative	Any patient will receive 10 mg intravenous metoclopramide immediately if there is nausea and vomiting
Postoperative Pain	up to 30 minutes, 2 hours and 4 hours postoperative	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
number of participant with side effects of acupuncture	up to 24 hours postoperative	bleeding, soreness, or bruising at the site of needle insertion
The time of discharge	up to 30 minutes postoperative	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
extubation time	up to 10 minutes postoperative	time from discontinuation of isoflurane to extubation

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Egypt