Unique ID issued by UMIN | UMIN000042898 |
---|---|
Receipt number | R000048969 |
Scientific Title | Efficacy of Mirogabalin and pain after total hip arthroplasty: a randomized controlled trial |
Date of disclosure of the study information | 2021/01/05 |
Last modified on | 2023/11/21 15:33:15 |
Efficacy of Mirogabalin and pain after total hip arthroplasty: a randomized controlled trial
Efficacy of Mirogabalin and pain after total hip arthroplasty: a randomized controlled trial
Efficacy of Mirogabalin and pain after total hip arthroplasty: a randomized controlled trial
Efficacy of Mirogabalin and pain after total hip arthroplasty: a randomized controlled trial
Japan |
Hip osteoarthritis
Orthopedics |
Others
NO
The authors of the present study conducted a randomized controlled trial to investigate the efficacy of milogabalin on the postoperative morphine consumption and side-effects, and pain score in patients undergoing THA.
Efficacy
The primary outcome was total fentanyl consumption over the initial 24h postoperatively.
The postoperative numerical rating scale (NRS) at rest, the active, and passive NRS score during hip exercise.
Chronic pain was evaluated using a chronic pain grading scale (CPGS) at 6 months after surgery.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Mirogabalin 15mg was given at 2 hours before surgery.
From 24 hours after surgery, study group patients received mirogabalin (15mg twice per day) for 2 days.
On the day of surgery, postoperative pain treatment consisted of two times intravenous acetaminophen 1000mg every 6 hours and an intravenous patient-controlled analgesia (PCA) fentanyl pump for 24 hours (The total volume of PCA was calculated from patient body weight) initiated immediately after back to the ward. The PCA pump was set to deliver fentanyl 50microgram/dose on demand with a 30 min lockout interval and no background infusion. However, the administration of intravenous acetaminophen was reduced to15mg/kg for patients with less than 50kg of body weight. From 24 hours after surgery, all patients were given oral acetaminophen (500mg every 8h) and celecoxib (100mg twice per day) for 7 days.
18 | years-old | <= |
80 | years-old | >= |
Male and Female
Patients recruited were of the American Society of Anesthesiologists (ASA) grade 1-3 rating, unilateral primary THA under general anesthesia, and the ability to cooperate with the investigation and understand the pain scale.
Exclusion criteria included patients with dementia or mental disorders, known drug allergy or tolerance to study drugs, renal insufficiency or abnormal liver enzymes, severe cardiovascular disease, severe diabetes, who have not been used the modified Watson-Jones approach, who have undergone bilateral simultaneous THA, and who have not passed more than 6 months from previous the other side THA.
80
1st name | Shigeo |
Middle name | |
Last name | Fukunishi |
Nishinomiya Kaisei hospital
Department of Orthopaedics
662-0957
4-1, Ohama-cho, Nishinomiya, Hyogo, Japan
0798-33-0601
fukunishi.shigeo@hmw.gr.jp
1st name | Yu |
Middle name | |
Last name | Takeda |
Nishinomiya Kaisei hospital
Department of Orthopaedics
662-0957
4-1, Ohama-cho, Nishinomiya, Hyogo, Japan
0798-33-0601
takeda.yu.0127@gmail.com
Nishinomiya Kaisei hospital
None
Other
Nishinomiya Kaisei hospital
4-1, Ohama-cho, Nishinomiya, Hyogo, Japan
0798-33-0601
None
NO
医療法人社団 西宮回生病院
2021 | Year | 01 | Month | 05 | Day |
Unpublished
Completed
2020 | Year | 07 | Month | 20 | Day |
2020 | Year | 06 | Month | 20 | Day |
2020 | Year | 07 | Month | 20 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 09 | Month | 07 | Day |
2023 | Year | 09 | Month | 20 | Day |
2023 | Year | 11 | Month | 30 | Day |
2021 | Year | 01 | Month | 04 | Day |
2023 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048969