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The Pain Intensity of the Patients Who Had Undergone Abdominal Surgery With a Midline Incision

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ClinicalTrials.gov Identifier: NCT03762486
Recruitment Status : Completed
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Bediye Oztas, Yuksek Ihtisas University

Study Description
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Brief Summary:
The purpose of this study is to determine the effects of transcutaneous electrical nerve stimulation (TENS) and transcutaneous acupoint electrical stimulation (TAES) on pain and analgesic drug consumption in patients who had undergone abdominal surgery with a midline incision. Evidence for the effects of and transcutaneous electrical stimulation on pain and analgesic consumption on patients undergoing abdominal surgery with severe pain experience and high levels of neuroendocrine stress response is uncertain.

Condition or disease Intervention/treatment Phase
Transcutaneous Electric Nerve Stimulation Other: TENS Other: TAES Not Applicable

Detailed Description:
This research was conducted as a randomized controlled trial. 158 patients who had undergone abdominal surgery with diagnosis of gastric and colorectal cancer were assessed for eligibility. This research sample consisted of 48 patients who underwent abdominal surgery with a midline incision. The patients were randomized into three groups, the first intervention group, which used TENS (around the incision), the second intervention group, which used TAES (ST25, P6, ST36, Lİ4 acupuncture points) and the control group, which did not. Electric stimulation was performed at the 30th minute, second, 18th, 21st, 40th, and 45th hours after the operation. Pain scores and analgesic consumption were assessed in the first 48 hours after surgical intervention.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

TENS was applied to around the insicion: Transcutaneous electrical nerve stimulation was applied to around the incision.

TAES was applied to acupuncture points: Transcutaneous electrical stimulation was applied to acupuncture points.

No intervention: No stimulation was performed to the patients.

A standard analgesia protocol for post-operative pain control was used in all patients included in the study. A standard antiemetic protocol was used for all patients after surgery.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Two Different Electrical Stimulation Methods on the Pain Intensity of the Patients Who Had Undergone Abdominal Surgery With a Midline Incision: Randomized Controlled Clinical Trial
Actual Study Start Date : May 12, 2015
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: TENS to around the incision
The Patient Controlled Analgesia infusion was started right after the surgery. TENS was applied to around the incision.
 Other: TENS
4 electrodes were placed 2-3 cm lateral to the incision of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min
Other Name: First Intervention Group
Active Comparator: TAES to the acupuncture points
The Patient Controlled Analgesia infusion was started right after the surgery. TAES was applied to acupuncture points.
 Other: TAES
4 electrodes were placed at the ST25, P6, ST36, and LI4 acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min
Other Name: Second Intervention Group
No Intervention: No stimulation
No stimulation was performed to the patients in the control group.


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative pain intensity [ Time Frame: The pain levels were evaluated and compared within postoperative first 48 hours. ]

    First Intervention Group: Electrical stimulation was implemented at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery.

    Second Intervention Group: Electrical stimulation was implemented at acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery.

    Control Group: No intervention was performed to the patients in the control group.

    The pain intensity of each groups' patients were recorded and compred at the post-operative 2, 18, 22, 42, and 46th hours. Pain intensity was evaluated with VAS. VAS with a range of 1-10 points was used while evaluating the pain intensity of all patients .The increase of the scale score shows that the pain intensity increases.



Secondary Outcome Measures :
  1. Nausea severity [ Time Frame: The nausea severity of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours. ]
    VAS with a range of 1-10 points was used while evaluating the nausea severity of all patients .The increase of the scale score shows that the nausea severity increases.

  2. Antiemetic drug consumption [ Time Frame: Antiemetic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours. ]
    The antiemetic drug amount administered to the patients was recorded in mg.

  3. Pulmonary function tests [ Time Frame: Pulmonary function evaluations of the patients were performed at the 24th and 48th hours. Patients were assessed in postoperative first 48 hours. ]
    The pulmonary functions of the patients were evaluated with a portable spirometer. Peak expiratory flow (PEF) and forced vital capacity (FVC) values were recorded. The measurement of respiratory functions was performed with the patient wrapping the disposable mouthpiece well with the lips during the measurement. The patient was asked to breathe deeply and exhale suddenly and quickly. This process was repeated three times and the best performance was taken as the base value.

  4. Vomiting [ Time Frame: Vomiting status of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours. ]
    Vomiting: The number of times the patients vomited was recorded

  5. Analgesic drug consumption [ Time Frame: Analgesic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours. ]
    All patients were administered intravenous tramadol hydrochloride infusion with the Patient Controlled Analgesia for the first 48 hours. Dexketoprofen trometamol vial intravenous and/or 50 mg. Pethidine hydrochloride intramuscular was used as the rescue analgesic.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who had an American Society of Anesthesiologists (ASA) score of I-II
  • Patients were aged over 18 years
  • Patients who could read and write Turkish
  • Patients who were scheduled to undergo elective abdominal surgery with a midline incision for a diagnosis of stomach or colorectal cancer
  • Patients without any impairment of vision, hearing or speech

Exclusion Criteria:

  • Patients who had a pacemaker
  • Patients whose skin integrity around the incision was degraded
  • Patients had a cognitive disorder, had a history of chronic pain, or were suffering from neurological, renal, cardiac or pulmonary disorders that could affect the test results
  • Patients with an opioid addiction
  • Patients those who had previously undergone electrical stimulation treatment
  • Morbidly obese subjects
  • Patients using psychoactive drugs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762486


Sponsors and Collaborators
Yuksek Ihtisas University
Investigators
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Study Director: Emine Iyigun, Professor Turkish Nurses Society
  Study Documents (Full-Text)

Documents provided by Bediye Oztas, Yuksek Ihtisas University:
Study Protocol and Statistical Analysis Plan  [PDF] May 1, 2015

More Information
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Additional Information:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

Publications of Results:

Other Publications:

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Responsible Party: Bediye Oztas, Teaching Staff, Yuksek Ihtisas University
ClinicalTrials.gov Identifier: NCT03762486    
Other Study ID Numbers: YuksekIU
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bediye Oztas, Yuksek Ihtisas University:
Postoperative pain
Alternative therapy
Acupuncture
 TENS
Surgical nursing
Randomised controlled trial
Additional relevant MeSH terms:
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Pain
Neurologic Manifestations