Effect of Acupuncture on Postoperative Nausea and Vomiting

Effect of Acupuncture on Postoperative Nausea and Vomiting in Lumbar Disc Herniation Surgeries

In this study, the hypothesis that bilateral acupuncture needling at the Neiguan (PC6) point during the intraoperative period, in addition to the 0.15 mg/kg dose of ondansetron (5-HT3 antagonist) frequently used for postoperative nausea and vomiting (PONV) prophylaxis in patients undergoing lumbar disc herniation surgery, would reduce the incidence of PONV was investigated. PONV was defined as the presence of nausea and vomiting within 24 hours postoperatively.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Nausea and Vomiting, Postoperative
• Intervention / Treatment: Other: acupuncture; Other: No acupuncture

Detailed Description

The study will include patients aged 18 years and over, with (American Society of Anesthesiologists) ASA physical status I to II, and scheduled for one or two-level lumbar disc herniation surgery under general anesthesia. Patient characteristics (age, gender, body mass index, etc.) and postoperative nausea and vomiting (PONV) risk factors such as history of PONV, motion sickness, and history of not smoking will be recorded. The primary outcome parameter will be the incidence of PONV within 24 hours postoperatively. The severity of nausea in patients who develop nausea in the postoperative period will be assessed using a Likert scale between 0 and 10. PONV will be defined as vomiting, significant nausea (numerical rating scale [NRS] ≥4), and/or need for rescue medication. Patients will be assessed for PONV at 0, 2, 4, 12, and 24 hours using a Likert scale. Emetic attacks, pain and severity of pain, nausea and severity of nausea, need for additional analgesics, and administration of antiemetic rescue medication will be assessed as secondary outcome parameters. The severity of pain and nausea in patients who develop postoperative pain will be assessed using an 11-point numerical rating scale, where '0' indicates the absence of symptoms and '10' indicates the maximum severity. PONV within the first two hours will be defined as 'early', and within 2-24 hours after awakening will be defined as 'late'. Nausea will be defined as the desire to vomit, and vomiting will be defined as the forceful expulsion of stomach contents.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Çankaya
    • Ankara, Ankara, Çankaya, Turkey, 06800
      • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 and above
• ASA physical status I to II
• One or two level lumbar disc herniation surgery under general anesthesia

Exclusion Criteria:

• body mass index >35 kg/m²)
• history of drug use
• nausea and vomiting before surgery
• psychiatric disorders
• use of antipsychotic or antiemetic drugs
• severe heart disease
• central nervous system diseases
• vertebrobasilar artery insufficiency
• cytostatic therapy
• vestibular diseases
• renal and/or hepatic dysfunction
• presence of fistula, neuropathy and paralysis in the extremity to be treated
• patient's refusal to accept acupuncture
• pregnant patients
• presence of bleeding diathesis
• patients in a condition where cooperation cannot be established in the post-operative period (mental retardation etc.)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acupuncture; patients will be given acupuncture in addition to standard medical treatment to prevent ponv	Other: acupuncture; patients will be given acupuncture in addition to standard medical treatment to prevent ponv
Active Comparator: No Acupuncture; patients will be given acupuncture in addition to standard medical treatment to prevent ponv	Other: No acupuncture; patients will be given standard medical treatment to prevent ponv

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PONV	The primary outcome of the study was the incidence of postoperative nausea and/or vomiting	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of nausea	The degree of nausea was evaluated using the visual analogue scale (VAS), with 0 indicating no nausea or vomiting and 10 indicating the most severe form of unbearable nausea or vomiting. When the PONV score was greater than 4 or vomiting occurs	24 hours
11 - point numerical rating scale (NRS)	11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.	24 hours
Rescue emetic requirement	Number of additional emetic applications	24 hours

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Actual): February 15, 2025
• Study Completion (Actual): March 15, 2025

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: acupuncture; postoperative nausea vomiting; apfel score
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: PONV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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