Effect of Acupuncture on Postoperative Nausea and Vomiting

March 14, 2025 updated by: Gökhan Erdem, Ankara City Hospital Bilkent

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PONV
Time Frame: 24 hours
The primary outcome of the study was the incidence of postoperative nausea and/or vomiting
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of nausea
Time Frame: 24 hours
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)
Time Frame: 24 hours
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
24 hours
Rescue emetic requirement
Time Frame: 24 hours
Number of additional emetic applications
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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