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

Primary Purpose

Transcutaneous Electric Nerve Stimulation

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

TENS

TAES

About this trial

This is an interventional supportive care trial for Transcutaneous Electric Nerve Stimulation focused on measuring Postoperative pain, Alternative therapy, Acupuncture, TENS, Surgical nursing, Randomised controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

TENS to around the incision

TAES to the acupuncture points

No stimulation

Arm Description

The Patient Controlled Analgesia infusion was started right after the surgery. TENS was applied to around the incision.

The Patient Controlled Analgesia infusion was started right after the surgery. TAES was applied to acupuncture points.

No stimulation was performed to the patients in the control group.

Outcomes

Primary Outcome Measures

Postoperative pain intensity

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

Nausea severity

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.

Antiemetic drug consumption

The antiemetic drug amount administered to the patients was recorded in mg.

Pulmonary function tests

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.

Vomiting

Vomiting: The number of times the patients vomited was recorded

Analgesic drug consumption

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.

Full Information

NCT ID

NCT03762486

First Posted

January 5, 2018

Last Updated

November 30, 2018

Sponsor

Yuksek Ihtisas University

1. Study Identification

Unique Protocol Identification Number

NCT03762486

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

May 12, 2015 (Actual)

Primary Completion Date

November 30, 2016 (Actual)

Study Completion Date

November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yuksek Ihtisas University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Transcutaneous Electric Nerve Stimulation

Keywords

Postoperative pain, Alternative therapy, Acupuncture, TENS, Surgical nursing, Randomised controlled trial

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

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)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TENS to around the incision

Arm Type

Active Comparator

Arm Description

The Patient Controlled Analgesia infusion was started right after the surgery. TENS was applied to around the incision.

Arm Title

TAES to the acupuncture points

Arm Type

Active Comparator

Arm Description

The Patient Controlled Analgesia infusion was started right after the surgery. TAES was applied to acupuncture points.

Arm Title

No stimulation

Arm Type

No Intervention

Arm Description

No stimulation was performed to the patients in the control group.

Intervention Type

Other

Intervention Name(s)

TENS

Other Intervention Name(s)

First Intervention Group

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

TAES

Other Intervention Name(s)

Second Intervention Group

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative pain intensity

Description

Time Frame

The pain levels were evaluated and compared within postoperative first 48 hours.

Secondary Outcome Measure Information:

Title

Nausea severity

Description

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.

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.

Title

Antiemetic drug consumption

Description

The antiemetic drug amount administered to the patients was recorded in mg.

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.

Title

Pulmonary function tests

Description

Time Frame

Pulmonary function evaluations of the patients were performed at the 24th and 48th hours. Patients were assessed in postoperative first 48 hours.

Title

Vomiting

Description

Vomiting: The number of times the patients vomited was recorded

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.

Title

Analgesic drug consumption

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emine Iyigun, Professor

Organizational Affiliation

Turkish Nurses Society

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

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Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/citmatch

Description

for access to resources

Available IPD and Supporting Information:

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.ncbi.nlm.nih.gov/pubmed/citmatch

Learn more about this trial

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

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