Clinical trial NCT03762486: 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
Overall status: COMPLETED
Phase: NA
Conditions: Transcutaneous Electric Nerve Stimulation
Keywords: Postoperative pain
Alternative therapy
Acupuncture
TENS
Surgical nursing
Randomised controlled trial
Lead sponsor: Yuksek Ihtisas University
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Postoperative pain intensity
timeFrame: The pain levels were evaluated and compared within postoperative first 48 hours.
Secondary outcomes:
measure: Nausea severity
timeFrame: 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.
measure: Antiemetic drug consumption
timeFrame: 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.
measure: Pulmonary function tests
timeFrame: Pulmonary function evaluations of the patients were performed at the 24th and 48th hours. Patients were assessed in postoperative first 48 hours.
measure: Vomiting
timeFrame: 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.
measure: Analgesic drug consumption
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Turkish Nurses Society
name: Emine Iyigun, Professor
role: STUDY_DIRECTOR
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