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Effectiveness of Positioning on Back Pain After TACE Among Patients With HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03784469
Recruitment Status : Completed
First Posted : December 24, 2018
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Changing patients' position in the bed after TACE can decrease the level of back pain without increasing the amount of bleeding and hematoma,bring patients some comfort and relieving abdominal bloating, increase patients' satisfaction.

Condition or disease Intervention/treatment Phase
Liver Cancer Transcatheter Arterial Chemoembolization Other: Changing body position in bed Not Applicable

Detailed Description:

Background:During the treatment for the liver cancer patients who are treated by Transcatheter Arterial Chemoembolization (TACE), the embolic agent with chemotherapeutic drugs are injected through a catheter into a femoral artery directly supplying the tumor. Hence, after the procedure, to avoid bleeding and hematoma at the puncture site, the puncture site at groin needs to be pressed by sandbag and the affected limb needs to remain straight. These patients have to lay down on beds and are not allowed to move for at least 4 hours. Due to pressure exerted continuously to the same muscles, may cause back muscle rigidity and spasms, these patients may suffer from back pain and discomfort. In addition to usual pharmacological treatment, nursing intervention aimed at decreasing patient discomfort, therefore, this study will refer to the previous researches to develop the methods and procedures of changing body positions and apply these methods to the liver cancer patients who are treated by TACE.

Purpose:The aim of this study was to compare the level of back pain and on the amount of bleeding and hematoma between those patients changing body positions in bed and those patients not changing body positions after TACE.

Methods: This study was a randomized clinical trial. The sample consisted of 78 patients who had undergone TACE via the femoral artery, patients by using a convenience sampling assigned to either the control or experimental group (each group consisting 39 participants). All patients need to be pressed on the puncture site at groin with a sand bag of 2.5 kg for 2 hours and lie down for 4 hours. The control group received the usual care, remaining supine position in complete bed rest and immobilized. Experimental group patients received position changes in the second hour and the fourth hour after TACE.

Results: The overall trend of back pain is different between the two groups ( p <.001) , the mean of pain intensity in the second ( p =.006) and the forth hour ( p <.001) showed a significant difference. Experimental group patients had significantly less back pain than the control group after TACE . For the within subjects factor of time, the levels of back pain differed significantly across the five-time periods in experimental group ( p < .05) . In the aspect of post embolization syndrome , control group patients had significantly abdominal bloating than the experimental group ( p =.003) . None of patients developed hematoma, there was no significant difference between the two groups in terms of amount of bleeding. On the whole, experimental group patients had significantly higher satisfaction than the control group ( p =.018).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Effectiveness of Positioning on Back Pain After Transcatheter Arterial Chemoembolization Among Patients With Hepatocellular Carcinoma
Actual Study Start Date : February 21, 2018
Actual Primary Completion Date : August 28, 2018
Actual Study Completion Date : August 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Changing body position in bed
The first hour:Supine position. The second hour:lateral position (right or left). The third hour:Supine position. The fourth hour:lateral position (right or left).
Other: Changing body position in bed
The first hour:Supine position. The second hour:lateral position (right or left). The third hour:Supine position. The fourth hour:lateral position (right or left).

No Intervention: Control group
No changing body position in bed,remaining supine position in complete bed rest and immobilized for four hours.



Primary Outcome Measures :
  1. The overall trend of back pain [ Time Frame: Within 4 hours after TACE ]
    The patients were asked to describe their back pain and rate its severity by using the Numerical Rating Scale (NRS-11).To determine if there is any significant difference the two groups. The NRS-11 with scores of 0 and 10 indicating no pain and excruciating pain, respectively.


Secondary Outcome Measures :
  1. The mean of back pain between two groups [ Time Frame: Within 4 hours after TACE ]
    The patients were asked to describe their back pain and rate its severity by using the Numerical Rating Scale (NRS).To determine if there is any significant difference the two groups.

  2. The mean of back pain in the experimental group [ Time Frame: Within 4 hours after TACE ]
    To determine if there is any significant difference across the five-time periods in experimental group.

  3. The mean of back pain in the control group [ Time Frame: Within 4 hours after TACE ]
    To determine if there is any significant difference across the five-time periods in control group.

  4. Vascular complication [ Time Frame: Femoral puncture sites were assessed every hourly for the following 4 hours by researcher and a nurse. ]
    The hematoma in femoral access site or there is blood on the yarn roll were visually checked, its margin was marked by a marker and its size was measured by using measuring paper. (The area equal to a square that is 1 millimeter on each side).

  5. Post embolization syndrome [ Time Frame: Within 4 hours after TACE. ]
    This is a dichotomized variable. Various common symptoms were listed and checked off based on the patient's report.

  6. Patients' satisfaction [ Time Frame: Patient's satisfaction will be evaluated at the 4th hour. ]
    5-Point Likert Scale: with scores of 5, 4, 3, 2, and 1 indicating highly satisfied, satisfied, neutral, dissatisfied, and highly dissatisfied, respectively. Higher scores mean higher satisfaction.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient with hepatocellular carcinoma hospitalized for TACE .
  2. Age ≧ 18.
  3. Consciousness can be communicated in Mandarin and Taiwanese.

Exclusion Criteria:

  1. Symptoms of back pain before TACE.
  2. Under the treatment of analagesics within 24 hours before TACE.
  3. Anticoagulant was not discontinued for at least 7 days before TACE.
  4. Inguinal hemorrhage or hematoma during the TACE or before removal of the vascular sheath.
  5. Hemological diseases that are prone to bleeding, i.e. hemophilia and leukemia.
  6. Platelet count lower than 70K or INR (international normalized ratio) is greater than 1.4.
  7. No hemostatic cotton use.
  8. Can not change the position in bed after TACE.

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): NCT03784469


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Tse-Pin Hsu, M.S.N. National Taiwan University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03784469    
Other Study ID Numbers: 201712022RIND
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: February 2018

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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 National Taiwan University Hospital:
Transcatheter Arterial Chemoembolization
position change
back pain
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations