Clinical trial NCT03784469: Effectiveness of Positioning on Back Pain After TACE Among Patients With HCC
Official title: Effectiveness of Positioning on Back Pain After Transcatheter Arterial Chemoembolization Among Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Transcatheter Arterial Chemoembolization
Keywords: Transcatheter Arterial Chemoembolization
position change
back pain
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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).

Eligibility 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.

Primary outcomes:
measure: The overall trend of back pain
timeFrame: Within 4 hours after TACE
Secondary outcomes:
measure: The mean of back pain between two groups
timeFrame: Within 4 hours after TACE
measure: The mean of back pain in the experimental group
timeFrame: Within 4 hours after TACE
measure: The mean of back pain in the control group
timeFrame: Within 4 hours after TACE
measure: Vascular complication
timeFrame: Femoral puncture sites were assessed every hourly for the following 4 hours by researcher and a nurse.
measure: Post embolization syndrome
timeFrame: Within 4 hours after TACE.
measure: Patients' satisfaction
timeFrame: Patient's satisfaction will be evaluated at the 4th hour.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Tse-Pin Hsu, M.S.N.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang KT, Liu CJ, Tsai HT, Hsu TP, Chen PT, Hu SH. Effects and safety of body positioning on back pain after transcatheter arterial chemoembolization in people with hepatocellular carcinoma: A randomized controlled study. Int J Nurs Stud. 2020 Sep;109:103641. doi: 10.1016/j.ijnurstu.2020.103641. Epub 2020 May 16.